TESTS GRANTED WAIVED STATUS UNDER CLIA
This list includes updates from Change Request FFS 10418
CPT CODE(S)
TEST NAME
MANUFACTURER
USE
81002
Dipstick or tablet reagent urinalysis –
non-automated for bilirubin, glucose,
hemoglobin, ketone, leukocytes, nitrite,
pH, protein, specific gravity, and
urobilinogen
Various
Screening of urine to monitor/diagnose various diseases/conditions, such as
diabetes, the state of the kidney or urinary tract, and urinary tract infections
81025
Urine pregnancy tests by visual color
comparison
Various
Diagnosis of pregnancy
82270
82272
(Contact your Medicare
carrier for claims
instructions.)
Fecal occult blood
Various
Detection of blood in feces from whatever cause, benign or malignant
(colorectal cancer screening)
82962
Blood glucose by glucose monitoring
devices cleared by the FDA for home
use
Various
Monitoring of blood glucose levels
83026
Hemoglobin by copper sulfate – non-
automated
Various
Monitors hemoglobin level in blood
84830
Ovulation tests by visual color
comparison for human luteinizing
hormone
Various
Detection of ovulation (optimal for conception)
85013
Blood count; spun microhematocrit
Various
Screen for anemia
85651
Erythrocyte sedimentation rate – non-
automated
Various
Nonspecific screening test for inflammatory activity, increased for majority
of infections, and most cases of carcinoma and leukemia
TESTS GRANTED WAIVED STATUS UNDER CLIA
This list includes updates from Change Request FFS 10418
* Newly added waived test system
2
CPT CODE(S)
TEST NAME
MANUFACTURER
USE
80047QW, 82330QW,
82374QW, 82435QW,
82565QW, 82947QW,
82950QW, 82951QW,
82952QW,
84132QW, 84295QW,
84520QW, 85014QW
Abbott i-STAT Chem8+ Cartridge
{Whole Blood}
i-STAT Corporation
Measures ionized calcium, carbon dioxide, chloride, creatinine, glucose,
potassium, sodium, urea nitrogen, and hematocrit in whole blood
80048QW
1. Abaxis Piccolo Blood Chemistry
Analyzer (Basic Metabolic
Reagent Disc){Whole Blood}
Abaxis, Inc
Measures total calcium, carbon dioxide, chloride, creatinine, glucose,
potassium, sodium, and urea nitrogen in whole blood
2. Abaxis Piccolo xpress Chemistry
Analyzer (Basic Metabolic
Reagent Disc){Whole Blood}
Abaxis, Inc
80051QW
1. Abaxis Piccolo Blood Chemistry
Analyzer (Electrolyte Metabolic
Reagent Disc){Whole Blood}
Abaxis, Inc.
Measures carbon dioxide, chloride, potassium, and sodium in whole blood
2. Abaxis Piccolo xpress Chemistry
Analyzer (Electrolyte Metabolic
Reagent Disc){Whole Blood}
Abaxis, Inc.
80053QW
1. Abaxis Piccolo Blood Chemistry
Analyzer (Comprehensive
Metabolic Reagent Disc){Whole
Blood}
Abaxis, Inc.
Measures alanine amino transferase, aspartate amino transferase, albumin,
total bilirubin, total calcium, carbon dioxide, chloride, creatinine, glucose,
alkaline phosphatase, potassium, total protein, sodium, and urea nitrogen in
whole blood
2. Abaxis Piccolo xpress Chemistry
Analyzer (Comprehensive
Metabolic Reagent Disc){Whole
Blood}
Abaxis, Inc.
TESTS GRANTED WAIVED STATUS UNDER CLIA
This list includes updates from Change Request FFS 10418
* Newly added waived test system
3
CPT CODE(S)
TEST NAME
MANUFACTURER
USE
80061QW, 82465QW
(Contact your Medicare
carrier for claims
instructions.),
83718QW,
84478QW
1. Abaxis, Piccolo xpress Chemistry
Analyzer {Lipid Panel Reagent
Disc} (Whole Blood)
Abaxis, Incorporated
Measures total cholesterol, HDL cholesterol, and triglycerides in whole
blood
2. Infopia USA LipidPro lipid profile
and glucose measuring system
(LipidPro Lipid Profile test strips)
Infopia Co., Ltd.
3. Jant Pharmacal Corp, LipidPlus
Professional Lipid Profile and
Glucose Measuring System
(LipidPlus Lipid Profile test strips)
Infopia Co., Ltd.
4. Piccolo Point of Care Chemistry
Analyzer (Lipid Panel Reagent
Disc) (Whole Blood)
Abaxis, Incorporated
5. Polymer Technology Systems
CardioChek PA Analyzer {PTS
Panels Lipid Panel Test Strips}
Polymer Technology
Systems, Inc.
6. Poylmer Technology Systems,
Inc., CardioChek Home Test
Systems (CardioChek Home Lipid
Panel test strips)
Polymer Technology
Systems, Inc.
7. Poylmer Technology Systems,
Inc., CardioChek Plus Test
Systems (PTS Panels Lipid Panel
test strips)
Polymer Technology
Systems, Inc.
80061QW, 82465QW
(Contact your Medicare
carrier for claims
instructions.),
82962,
83718QW,
84478QW
1. Jant Pharmacal LipidPlus Lipid
Profile and Glucose Measuring
System
Infopia Co., Ltd.
Monitoring of blood glucose levels and measures total cholesterol, HDL
cholesterol, and triglycerides in whole blood
TESTS GRANTED WAIVED STATUS UNDER CLIA
This list includes updates from Change Request FFS 10418
* Newly added waived test system
4
CPT CODE(S)
TEST NAME
MANUFACTURER
USE
80061QW, 82465QW
(cont.)(Contact your
Medicare carrier for
claims instructions.),
82962,
83718QW,
84478QW
2. Jant Pharmacal Corp, LipidPlus
Professional Lipid Profile and
Glucose Measuring System
Infopia Co., Ltd
Monitoring of blood glucose levels and measures total cholesterol, HDL
cholesterol, and triglycerides in whole blood
3. Infopia USA LipidPro lipid profile
and glucose measuring system
Infopia Co., Ltd.
4. Infopia USA LipidPro
Professional Lipid Profile and
Glucose Measuring System
Infopia Co., Ltd
80061QW, 82465QW
(Contact your Medicare
carrier for claims
instructions.),
83718QW,
84460QW,
84478QW
Cholestech LDX (Lipid Profile – ALT
(GPT)){Whole Blood}
Cholestech Corp.
Measures alanine aminotransferase, total cholesterol, HDL cholesterol, and
triglycerides in whole blood
80061QW, 82465QW
82465QW (Contact your
Medicare carrier for
claims instructions.),
82947QW, 82950QW,
82951QW, 82952QW,
83718QW, 84450QW,
84460QW, 84478QW
Alere Cholestech LDX {Whole Blood}
Alere, Inc.
Measures alanine aminotransferase, aspartate aminotransferase, total
cholesterol, HDL cholesterol, glucose, and triglycerides in whole blood
80069QW
1. Abaxis Piccolo Blood Chemistry
Analyzer (Piccolo Renal Function
Panel){Whole Blood}
Abaxis, Incorporated
Measures albumin, total calcium, total carbon dioxide, chloride, creatinine,
glucose, phosphorus, potassium, sodium and urea nitrogen in whole blood
2. Abaxis Piccolo xpress Chemistry
Analyzer (Piccolo Renal Function
Panel){Whole Blood}
Abaxis, Incorporated
TESTS GRANTED WAIVED STATUS UNDER CLIA
This list includes updates from Change Request FFS 10418
* Newly added waived test system
5
CPT CODE(S)
TEST NAME
MANUFACTURER
USE
80178QW
ReliaLAB Inc. InstaRead Lithium
System {fingerstick or venipuncture
whole blood}
Akers Laboratories, Inc.
Measures lithium blood levels in whole blood
80305QW (This test
may not be covered in
all instances. Contact
your Medicare carrier
for claims instructions.)
Drug test(s), presumptive, any number
of drug classes; any number of devices
or procedures, (e.g., immunoassay)
capable of being read by direct optical
observation only (e.g., dipsticks, cups,
cards, cartridges) categorized as
waived complexity. Refer to the FDA
website
http://www.accessdata.fda.gov/scripts/
cdrh/cfdocs/cfClia/analyteswaived.cfm
for the currently waived test systems
and analytes.
Various
Screening test for the presence/detection of any number of drug classes in
urine
81003QW
Dipstick or tablet reagent urinalysis –
automated for bilirubin, glucose,
hemoglobin, ketone, leukocytes, nitrite,
pH, protein, specific gravity, and
urobilinogen categorized as waived
complexity. Refer to the FDA website
http://www.accessdata.fda.gov/scripts/
cdrh/cfdocs/cfClia/analyteswaived.cfm
for the currently waived test systems.
Various
Screening of urine to monitor/diagnose various diseases/conditions, such as
diabetes, the state of the kidney or urinary tract, and urinary tract infections
81003QW, 82044QW,
82570QW
1. Siemens Clinitek 50 Urine
Chemistry Analyzer
Siemens Healthcare
Diagnostics Inc.
Screening of urine to monitor/diagnose various diseases/conditions, such as
diabetes, the state of the kidney or urinary tract, and urinary tract infections;
and the semi-quantitative measurement of albumin and creatinine in urine
81003QW, 82044QW,
82570QW,
84703QW
1. Siemens Clinitek Status Urine
Chemistry Analyzer
Siemens Healthcare
Diagnostics
Screening of urine to monitor/diagnose various diseases/conditions, such as
diabetes, the state of the kidney or urinary tract, and urinary tract infections;
the semi-quantitative measurement of albumin and creatinine in urine; and
the diagnosis of pregnancy
2. Siemens, Clinitek Status+
Analyzer
Siemens Healthcare
Diagnostics
TESTS GRANTED WAIVED STATUS UNDER CLIA
This list includes updates from Change Request FFS 10418
* Newly added waived test system
6
CPT CODE(S)
TEST NAME
MANUFACTURER
USE
81003QW, 82044QW,
82570QW,
84703QW
3. Siemens, Clinitek Status Connect
System
Siemens Healthcare
Diagnostics
Screening of urine to monitor/diagnose various diseases/conditions, such as
diabetes, the state of the kidney or urinary tract, and urinary tract infections;
the semi-quantitative measurement of albumin and creatinine in urine; and
the diagnosis of pregnancy
81007QW
1. Diatech Diagnostics Uriscreen (for
OTC use)
Savyon/USA
Detects catalase in urine which is associated with urinary tract infections
(UTIs). White blood cells and some bacteria associated with UTIs are
positive for catalase.
2. Jant Pharmacal Corporation
Accutest Uriscreen (Bacteriuria)
Savyon Diagnostics Ltd
82010QW
PTS Bioscanner (for OTC use) - for
blood ketones
Polymer Technology
Systems, Inc.
Measures ketones in whole blood
82010QW,
82962
1. Abbott Laboratories, Medisense
Products Precision Xtra
Advanced Diabetes Management
System (K983504)
Abbott Laboratories
Monitoring of blood glucose levels and measures ketones in whole blood
2. Abbott Medisense Precision Xtra
Advanced Diabetes Management
System (K040814)
Abbott Laboratories
3. Nova Biomedical Nova Max Plus
Glucose and B-Ketone Monitoring
System
Nova Biomedical Corp.
82040QW, 82150QW,
82247QW, 82310QW,
82565QW, 82947QW,
82950QW, 82951QW,
82952QW,
82977QW, 84075QW,
84155 QW, 84450QW,
84460QW, 84520QW,
84550QW
Abaxis Piccolo Blood Chemistry
Analyzer (General Chemistry 13
Panel){Whole Blood}
Abaxis, Inc.
Quantitative measurement of alanine aminotransferase, albumin, alkaline
phosphatase, amylase, aspartate aminotransferase, calcium, creatinine,
gamma glutamyltransferase, glucose, total bilirubin, total protein, urea
nitrogen and uric acid in whole blood
TESTS GRANTED WAIVED STATUS UNDER CLIA
This list includes updates from Change Request FFS 10418
* Newly added waived test system
7
CPT CODE(S)
TEST NAME
MANUFACTURER
USE
82040QW, 82150QW,
82247QW, 82310QW,
82565QW, 82947QW,
82950QW, 82951QW,
82952QW,
82977QW, 84075QW,
84155 QW, 84450QW,
84460QW, 84520QW,
84550QW
Abaxis Piccolo xpress Chemistry
Analyzer (General Chemistry 13
Panel){Whole Blood}
Abaxis, Inc.
Quantitative measurement of alanine aminotransferase, albumin, alkaline
phosphatase, amylase, aspartate aminotransferase, calcium, creatinine,
gamma glutamyltransferase, glucose, total bilirubin, total protein, urea
nitrogen and uric acid in whole blood
82040QW, 82150QW,
82247QW,
82977QW, 84075QW,
84155QW, 84450QW,
84460QW
1. Abaxis Piccolo Point of Care
Chemistry Analyzer (Liver Panel
Plus Reagent Disc){whole blood}
Abaxis, Inc.
Measures alanine aminotransferase, albumin, alkaline phosphatase, amylase,
aspartate aminotransferase, gamma glutamyltransferase, total bilirubin and
total protein levels in whole blood
2. Abaxis Piccolo xpress Chemistry
Analyzer {Liver Panel
Plus} (Whole Blood)
Abaxis, Inc
82040QW, 82310QW,
82565QW, 82947QW,
82950QW, 82951QW,
82952QW, 84520QW
Arkay SPOTCHEM EZ Chemistry
Analyzer (Spotchem II Basicpanel 1)
{Whole Blood}
Polymedco, Inc.
Measures albumin, total calcium, creatinine, glucose and total protein
levels in whole blood
82043QW
HemoCue Albumin 201 System
HemoCue, Inc.
Quantitative measurement of albumin in urine by immunoassay
82044QW, 82570QW
Acon Laboratories, Inc. Mission U120
Urine Chemistry Test System (Mission
Urinalysis Reagent Strips
(Microalbumin/Creatinine))
ACON Laboratories, Inc.
Semi-quantitative measurement of albumin and creatinine in urine
82120QW,
83986QW
Litmus Concepts FemExam TestCard
(from vaginal swab)
Litmus Concepts, Inc.
Qualitative test of a vaginal fluid sample for elevated pH (pH greater than or
equal to 4.7) and the presence of volatile amines
82247QW, 84075QW,
84155QW, 84450QW,
84460QW
Arkay SPOTCHEM EZ Chemistry
Analyer (Spotchem II Basicpanel 2)
{Whole Blood}
Polymedco, Inc.
Measures alanine aminotransferase, alkaline phosphatase, aspartate
aminotransferase, total bilirubin and urea levels in whole blood
82271QW
1. Aerscher Hemaprompt FG
Aerscher Diagnostics
Rapid screening test to detect the presence of gastric occult blood
TESTS GRANTED WAIVED STATUS UNDER CLIA
This list includes updates from Change Request FFS 10418
* Newly added waived test system
8
CPT CODE(S)
TEST NAME
MANUFACTURER
USE
82271QW (cont.)
2. SmithKline Gastroccult
SmithKline
Rapid screening test to detect the presence of gastric occult blood
82271QW,
83986QW
Beckman Coulter Primary Care
Diagnostics Gastrocult
Beckman Coulter, Inc.
Rapid screening test to detect the presence of gastric occult blood and
determine the pH (acid-base balance) of gastric aspirates
82274QW
G0328QW
Colorectal cancer screening; fecal
occult blood test, immunoassay, 1-3
simultaneous categorized as waived
complexity. . Refer to the FDA
website
http://www.accessdata.fda.gov/scripts/
cdrh/cfdocs/cfClia/analyteswaived.cfm
for the currently waived test systems.
Various
Detection of blood in feces from whatever cause, benign or malignant
(colorectal cancer screening) by immunoassay
82374QW, 82435QW,
82550QW, 82565QW,
82947QW, 84132QW,
84295QW, 84520QW
1. Abaxis Piccolo Blood Chemistry
Analyzer (Piccolo Metlyte 8 Panel
Reagent Disc) {Whole Blood}
Abaxis, Inc.
Measures chloride, creatine kinase, creatinine, glucose, potassium, sodium,
total carbon dioxide and urea nitrogen (BUN) in whole blood
2. Abaxis Piccolo xpress Chemistry
Analyzer (Piccolo Metlyte 8 Panel
Reagent Disc) {Whole Blood}
Abaxis, Inc
82435QW, 82947QW,
82950QW, 82951QW,
82952QW, 84132QW,
84295QW, 84520QW,
85014QW
Abbott i-STAT 6+ Cartridge {Whole
Blood}
i-Stat Corporation
Measures chloride, glucose, potassium, sodium, urea nitrogen, and
hematocrit in whole blood
82465QW (Contact your
Medicare carrier for
claims instructions.)
1. Advanced Care
Johnson & Johnson
Cholesterol monitoring
2. Boehringer Mannheim Accu-Chek
InstantPlus Cholesterol
Boehringer Mannheim
3. ChemTrak AccuMeter
ChemTrak
4. ENA.C.T Total Cholesterol Test
ActiMed Laboratories, Inc.
5. ActiMed Laboratories ENA.C.T.
Total Cholesterol Test (PDU)
ActiMed Laboratories, Inc.
TESTS GRANTED WAIVED STATUS UNDER CLIA
This list includes updates from Change Request FFS 10418
* Newly added waived test system
9
CPT CODE(S)
TEST NAME
MANUFACTURER
USE
82465QW (cont.)
(Contact your Medicare
carrier for claims
instructions.)
6. Lifestream Technologies
Cholesterol Monitor
Lifestream Technologies,
Inc.
Cholesterol monitoring
7. Lifestream Technologies Personal
Cholesterol Monitor
Lifestream Technologies,
Inc.
8. Polymer Technology Systems
(PTS) MTM Bioscanner 1000 (for
OTC use) for cholesterol
Polymer Technology
Systems, Inc.
9. PTS Bioscanner Test Strips
Chloesterol
Polymer Technology
Systems, Inc.
82465QW (Contact your
Medicare carrier for
claims instructions.),
82947QW, 82950QW,
82951QW, 82952QW
1. Polymer Technology Systems,
Inc., CardioChek Home Test
System (CardioChek Home
Chol+Glu test strips)
Polymer Technology
Systems, Inc.
Measures total cholesterol, and glucose in whole blood
2. Polymer Technology Systems,
Inc., CardioChek Plus Test System
(PTS Panels Chol+Glu test strips)
Polymer Technology
Systems, Inc.
82465QW (Contact your
Medicare carrier for
claims instructions.),
83718QW
1. Polymer Technology Systems
CardioChek Brand Analyzer (PTS
Panels CHOL+HDL Panel Test
Strips)
Polymer Technology
Systems, Inc.
Measures total cholesterol and HDL cholesterol in whole blood
2. Polymer Technology Systems,
Inc., CardioChek Home Test
System (CardioChek Home
Chol+HDL test strips)
3. Polymer Technology Systems
CardioChek PA Analyzer (PTS
Panels CHOL+HDL Panel Test
Strips)
Polymer Technology
Systems, Inc.
4. Polymer Technology Systems
Cardiochek PA Analyzer (PTS
Panels CHOL+HDL Test Panel
Test Strips)
Polymer Technology
Systems, Inc.
TESTS GRANTED WAIVED STATUS UNDER CLIA
This list includes updates from Change Request FFS 10418
* Newly added waived test system
10
CPT CODE(S)
TEST NAME
MANUFACTURER
USE
82465QW (Contact your
Medicare carrier for
claims instructions.),
83718QW (cont.)
5. Polymer Technology Systems
Cardiochek PA Analyzer (PTS
Panels Chol + Glu Test Panel)
Polymer Technology
Systems, Inc.
Measures total cholesterol and HDL cholesterol in whole blood
6. Polymer Technology Systems,
Inc., CardioChek Plus Test System
(PTS Panels Chol+HDL test
strips)
Polymer Technology
Systems, Inc.
7. Roche Diagnostics AccuChek
Instant Plus Dual Testing System
Roche Diagnostics
82465QW (Contact your
Medicare carrier for
claims instructions.),
83718QW,
82947QW, 82950QW,
82951QW, 82952QW
1. Polymer Technology Systems
CardioChek Brand Analyzer (PTS
Panels CHOL+HDL+GLUC Panel
Test Strips)
Polymer Technology
Systems, Inc.
Measures total cholesterol, HDL cholesterol, and glucose in whole blood
2. Polymer Technology Systems,
Inc., CardioChek Home Test
System (CardioChek Home
Chol+HDL+Glu test strips)
Polymer Technology
Systems, Inc.
3. Polymer Technology Systems,
Inc., CardioChek Plus Test System
(PTS Panels Chol+HDL+Glu test
strips)
Polymer Technology
Systems, Inc.
4. Polymer Technology Systems
CardioChek PA Analyzer (PTS
Panels CHOL+HDL+GLUC Panel
Test Strips)
Polymer Technology
Systems, Inc.
TESTS GRANTED WAIVED STATUS UNDER CLIA
This list includes updates from Change Request FFS 10418
* Newly added waived test system
11
CPT CODE(S)
TEST NAME
MANUFACTURER
USE
82465QW (Contact your
Medicare carrier for
claims instructions.),
82947QW, 82950QW,
82951QW, 82952QW,
83718QW,
84478QW,
80061QW
Cholestech LDX
Cholestech Corp.
Measures total cholesterol, glucose, HDL cholesterol, and triglycerides in
whole blood
82465QW (Contact your
Medicare carrier for
claims instructions.),
82947QW, 82950QW,
82951QW, 82952QW,
83036QW,
84478QW
Wako APOLOWAKO Analyzer
(Whole Blood)
Wako Chemicals USA, Inc.
Measures total cholesterol, hemoglobin A1c, glucose, and triglycerides in
whole blood
82465QW(Contact your
Medicare carrier for
claims instructions.),
82947QW, 82950QW,
82951QW, 82952QW,
83718QW, 84478QW,
84450QW, 84460QW
Abaxis Piccolo xpress Chemistry
Analyzer {Lipid Panel Plus Reagent
Disc} (Whole Blood)}
Abaxis, Inc.
Measures cholesterol, HDL cholesterol, glucose, alanine aminotransferase,
aspartate aminotransferase, and triglycerides in whole blood
82523QW
Ostex International Osteomark NTX
Point of Care Prescription Home Use
Ostex International Inc.
Measures normalized cross-linked N-telopeptides of type 1 collagen in urine
82565QW
Abbott i-STAT Crea Cartridge {Whole
Blood}
i-Stat Corporation
Quantitative measurement of creatinine in whole blood
82565QW, 84520QW
Abaxis Piccolo xpress Chemistry
Analyzer (Kidney Check
Panel){Whole Blood}
Abaxis, Inc.
Quantitative measurement of creatinine and urea nitrogen in whole blood
TESTS GRANTED WAIVED STATUS UNDER CLIA
This list includes updates from Change Request FFS 10418
* Newly added waived test system
12
CPT CODE(S)
TEST NAME
MANUFACTURER
USE
82565QW, 82947QW,
82950QW, 82951QW,
82952QW,
82977QW, 84450QW,
84460QW, 84520QW
1. Abaxis Piccolo Blood Chemistry
Analyzer (General Chemistry 6
Panel){Whole Blood}
Abaxis, Inc.
Quantitative measurement of alanine aminotransferase, aspartate
aminotransferase, creatinine, gamma glutamyltransferase, glucose and urea
nitrogen in whole blood
2. Abaxis Piccolo xpress Chemistry
Analyzer (General Chemistry 6
Panel){Whole Blood}
Abaxis, Inc.
82679QW (This test
may not be covered in
all instances. Contact
your Medicare carrier
for claims instructions.),
83002QW
Clearplan Easy Fertility Monitor (for
luteinizing hormone and estrone 3
glucuronide)
Unipath Limited
Detection of luteinizing hormone and estrone 3 glucuronide in urine to
identify the optimal time for conception
82947QW, 82950QW,
82951QW, 82952QW
1. HemoCue B-Glucose Photometer
HemoCue, Inc.
Measures glucose levels in whole blood
82947QW, 82950QW,
82951QW, 82952QW
(cont.)
2. HemoCue Glucose 201
Microcuvettes and Glucose 201
Analyzer
HemoCue, Inc.
Measures glucose levels in whole blood
3. Abbott i-STAT G Cartridge
{Whole Blood}
i-Stat Corporation
82947QW, 82950QW,
82951QW, 82952QW,
84132QW, 84295QW,
85014QW
Abbott i-STAT EC4+ Cartridge
{Whole Blood}
i-Stat Corporation
Measures glucose, potassium, sodium, and hematocrit in whole blood
82962,
82465QW (Contact your
Medicare carrier for
claims instructions.)
Roche Diagnostics Accutrend Plus
System {fingerstick whole blood}
Roche Diagnostics
Monitoring of blood glucose levels and cholesterol
82962,
82985QW
1. LXN Duet Glucose Control
Monitoring System
LXN Corporation
Monitoring of blood glucose levels and measures fructosamine, which is
used to evaluate diabetic control, reflecting diabetic control over a 2-3 week
period
TESTS GRANTED WAIVED STATUS UNDER CLIA
This list includes updates from Change Request FFS 10418
* Newly added waived test system
13
CPT CODE(S)
TEST NAME
MANUFACTURER
USE
82962,
82985QW (cont.)
2. LXN IN CHARGE Diabetes
Control System
LXN Corporation
Monitoring of blood glucose levels and measures fructosamine, which is
used to evaluate diabetic control, reflecting diabetic control over a 2-3 week
period
82985QW
LXN Fructosamine Test System
LXN Corporation
Used to evaluate diabetic control, reflecting diabetic control over a 2-3 week
period (Not a useful test for screening diabetes mellitus)
82947QW
1. Poylmer Technology Systems,
Inc., CardioChek Home Test
Systems (CardioChek Home
Glucose test strips)
Polymer Technology
Systems, Inc.
Measures glucose in whole blood
2. Poylmer Technology Systems,
Inc., CardioChek Home Test
Systems (CardioChek Home
eGLU test strips)
Polymer Technology
Systems, Inc.
3. Poylmer Technology Systems,
Inc., CardioChek Plus Test
Systems (PTS Panels Glucose test
strips
Polymer Technology
Systems, Inc.
4. Poylmer Technology Systems,
Inc., CardioChek Plus Test
Systems (PTS Panels eGLU test
strips)
Polymer Technology
Systems, Inc.
83001QW
1. Acon Laboratories, Inc. FSH
Menopause Predictor Test
ACON Laboratories, Inc.
Detects follicle stimulating hormone in urine
2. Acon Laboratories, Inc. FSH One
Step Menopause Test Device
{Professional Use}
ACON Laboratories, Inc.
3. Acon Laboratories, Inc. FSH One
Step Menopause Test Strip
{Professional Use}
ACON Laboratories, Inc.
4. Applied Biotech, Inc. RU25 Plus
FSH Menopause Test
Applied Biotech, Inc.
5. Biotechnostix, Inc. Rapid
Response FSH One Step
Menopause Test Device
ACON Laboratories, Inc.
TESTS GRANTED WAIVED STATUS UNDER CLIA
This list includes updates from Change Request FFS 10418
* Newly added waived test system
14
CPT CODE(S)
TEST NAME
MANUFACTURER
USE
83001QW (cont.)
6. Genosis Fertell Female Fertility
Test
Genosis, Inc.
Detects follicle stimulating hormone in urine
7. Genua Menopause Monitor Test
Genua 1944 Inc
8. Synova Healthcare MenocheckPro
(Professional Use)
Applied Biotech, Inc.
83036QW
1. Axis-Shield Afinion AS100
Analyzer
Axis-Shield Poc
Measures the percent concentration of hemoglobin A1c in blood, which is
used in monitoring the long-term care of people with diabetes
2. Alere Technologies AS, Alere
Afinion AS101 Analyzer
Axis-Shield Poc
3. Bayer AICNow+ Professional Use
Bayer Healthcare, LLC
4. Siemens Medical Diagnostics
DCA Vantage Analyzer
Siemens Healthcare
Diagnostics, Inc.
5. PTS Diagnostics A1CNow +
Professional Use
Polymer Technology
Systems, Inc.
6. Siemens DCA 2000 Analyzer
Siemens Healthcare
Diagnostics, Inc.
7. Siemens DCA 2000+ Analyzer
Siemens Healthcare
Diagnostics, Inc
83037QW
1. Bayer A1CNow+ {For
professional use}
Bayer Corp.
Measures the percent concentration of hemoglobin A1c in blood, which is
used in monitoring the long-term care of people with diabetes using devices
cleared by the FDA for home use
2. Bayer A1C Now SelfCheck
Bayer Healthcare, Llc.
3. BIO-RAD in2it (II) System
Analyzer Prescription Home Use
Bio-Rad Laboratories, Inc.
4. Bio-Rad Micromat II Hemoglobin
A1c Prescription Home Use Test
Bio-Rad Laboratories, Inc.
5. Cholestech GDX A1C Test
(Prescription Home Use)
Cholestech Corporation
6. Provalis Diagnostics Glycosal
HbA1c Test
Provalis Diagnostics Ltd.
TESTS GRANTED WAIVED STATUS UNDER CLIA
This list includes updates from Change Request FFS 10418
* Newly added waived test system
15
CPT CODE(S)
TEST NAME
MANUFACTURER
USE
83037QW (cont.)
7. Provalis Diagnostics In2it In-
Office Analyzer (II) Prescription
Home Use Test System
Provalis Diagnostics Ltd
Measures the percent concentration of hemoglobin A1c in blood, which is
used in monitoring the long-term care of people with diabetes using devices
cleared by the FDA for home use
83516QW
1. Rapid Pathogen Screening, Inc.
InflammaDry
Rapid Pathogen Screening,
Inc.
Detection of elevated levels of the MMP-9 protein in human tears, from
patients suspected of having dry eye.
2. Quidel Corporation,
InflammaDry*
Quidel Corporation
82044QW
1. Beckman Coulter ICON Microalb
Beckman Coulter, Inc.
Determination of low concentrations of albumin in urine by immunoassay,
which is helpful for early detection in patients at risk for developing renal
disease
2. Boehringer Mannheim Chemstrip
Micral
Boehringer Mannheim
3. Diagnostic Chemicals
ImmunoDip Urinary Albumin
Test
Diagnostic Chemicals
Limited
4. Diagnostic Chemicals
ImmunoDip Urinary Albumin
Screen (Urine Dipstick)
Diagnostic Chemicals
Limited (USA)
5. Genzyme Diagnostics OSOM
ImmunoDip Urinary Albumin Test
Genzyme Diagnositcs
6. Roche Diagnostics Chemstrip
Micral (urine dipstick)
Roche Diagnostics
Corporation
83605QW
KDK Corporation Lactate Pro System
KDK Corporation
Quantitative measurement of lactate in whole blood
83655QW
ESA Biosciences LeadCare II Blood
Lead Testing System (whole blood)
ESA Biosciences, Inc.
Quantitative measurement of blood lead in whole blood
83718QW,
84478QW,
82947QW, 82950QW,
82951QW, 82952QW
Polymer Technology Systems
CardioChek PA Analyzer (PTS Panels
Metabolic Chemistry Panel Test Strips)
Polymer Technology
Systems, Inc.
Measures HDL cholesterol, triglycerides, and glucose in whole blood
83721QW
Polymer Technology Systems
Cardiochek PA Analyzer
Polymer Technology
Systems, Inc.
Measures LDL cholesterol in whole blood
TESTS GRANTED WAIVED STATUS UNDER CLIA
This list includes updates from Change Request FFS 10418
* Newly added waived test system
16
CPT CODE(S)
TEST NAME
MANUFACTURER
USE
83861QW
TearLab Corporation TearLab
Osmolarity System
TearLab Corporation
Impedance measurement of tear fluid to provide an indirect assessment of
osmolarity.
83880QW
1. Biosite Triage Meter {Whole
Blood}
2. Biosite Triage Meter Plus {Whole
Blood}
Biosite Incorporated
Quantitative measurement of B-type natriuretic peptide (BNP)
83986QW
All qualitative color comparison pH
testing - body fluids (other than blood)
Various
pH detection (acid-base balance) in body fluids such as semen, amniotic
fluid, and gastric aspirates
83986QW
1. Dale Medical Products, Inc.
RightLevel pH
EZ-NG, LLC.
Gastric pH detection (acid-base balance)
2. Dale Medical Products, Inc.
RightSpot pH
EZ-NG, LLC.
3. RightBio Metrics, RightSpot
Infant pH Indicator
Right BioMetrics
4. RightBio Metrics, RightSpot pH
Detector
Right BioMetrics
5. RightBio Metrics, RightSpot pH
Indicator
Right BioMetrics
83986QW
1. FemTek pHEM-ALERT
FemTek, LLC
Vaginal pH detection (acid-base balance)
2. Common Sense Ltd. Norma-Sense
Vaginal Discharge pH Test
Common Sense Ltd.
3. Common Sense Ltd. VA-Sense Kit
Common Sense, Ltd.
4. Common Sense Ltd. VS-Sense
Test {qualitative}
Common Sense, Ltd
5. Lil’ Drug Store Products Inc.
Vagi-Screen Vaginal Health Test
Lil’ Drug Store Products Inc.
6. Teco Diagnostics OBGYN-VpH
Vaginal pH Screening Kit
Teco Diagnositcs
84295QW, 84132QW,
85014QW
Abbott i-STAT E3+ Cartridge {Whole
Blood}
i-Stat Corporation
Measures potassium, sodium, and hematocrit in whole blood
TESTS GRANTED WAIVED STATUS UNDER CLIA
This list includes updates from Change Request FFS 10418
* Newly added waived test system
17
CPT CODE(S)
TEST NAME
MANUFACTURER
USE
84443QW
1. Aventir Biotech LLC, Forsure
TSH Test {Whole Blood}
Screening Devices Canada
Inc.
Qualitative determination of human thyroid stimulating hormone (TSH) in
whole blood, which is a rapid TSH assay for hypothyroidism screening in
adults
2. BTNX, Rapid Response Thyroid
Stimulating Hormone (TSH) Test
Cassette
Screening Devices Canada
Inc.
3. BTNX, Inc Rapid Response
Thyroid Stimulating Hormone
(TSH) Test Cassette
Screening Devices Canada
Inc.
4. CLIAwaived Inc. Thyroid Test
Rapid TSH Cassette {Whole
Blood}
Screening Devices Canada
Inc.
5. Germaine Laboratories, Inc.
AimStep Thyroid Screen {whole
blood}
Screening Devices Canada
Inc.
6. ThyroTec, Inc. ThyroTest Whole
Blood TSH Test
ThyroTec, Inc.
7. Jant Pharmacal Accutest TSH
{Whole Blood}
Screening Devices Canada
Inc.
8. Qualigen, Inc. FastChek TSH
{Whole blood}
Screening Devices Canada
Inc.
84450QW, 84520QW
Arkray SPOTCHEM EZ Chemistry
Analyzer{whole blood}
Arkray, Inc.
Quantitative determination of blood urea nitrogen (BUN) and aspartate
aminotransferase in whole blood
84450QW
Cholestech LDX Aspartate
Aminotransferase (AST)(SGOT)
Cholestech Corporation
Quantitative determination of aspartate aminotransferase in whole blood
84460QW
Cholestech LDX Alanine
Aminotransferase (ALT) Test
Cholestech Corporation
Quantitative determination of alanine aminotransferase in whole blood
84703QW
Bayer Clinitek 50 Urine Chemistry
Analyzer - for HCG, urine
Bayer Corp.
Diagnosis of pregnancy
85014QW
Wampole STAT-CRIT Hct
Wampole Laboratories
Screen for anemia
85018QW
1. AimStrip Hb Hemoglobin (Hb)
Testing System
Acon Laboratories, Inc.
Measures hemoglobin level in whole blood
2. Alere HemoPoint H2 System
Stanbio Laboratory
TESTS GRANTED WAIVED STATUS UNDER CLIA
This list includes updates from Change Request FFS 10418
* Newly added waived test system
18
CPT CODE(S)
TEST NAME
MANUFACTURER
USE
85018QW (cont.)
3. Biosafe Laboratories, Inc.,
Anemiapro Self Screener
Biosafe Laboratories, Inc.
Measures hemoglobin level in whole blood
4. Clarity HbCheck Hemoglobin
Testing System
Acon Laboratories, Inc.
5. HemoCue Donor Hemoglobin
Checker System HemoCue
HemoCue, Inc.
6. HemoCue Hemoglobin System
HemoCue, Inc.
7. HemoCue Hemoglobin 201+
(Capillary, Venous, Arterial
Whole Blood)
HemoCue, Inc.
8. HemoCue Hemoglobin
201+/HemoCue Hemoglobin
Microcuvette System
HemoCue, Inc.
9. HemoCue Hb 301 System
HemoCue, Inc.
10. GDS Diagnostics HemoSite Meter
- for hemoglobin
GDS Technology, Inc.
11. GDS Technology STAT-Site
MHgb Test System
GDS Technology
85025QW
Sysmex XW-100*
Sysmex America, Inc.
Quantitative automated hematology analyzer intended using anticoagulated
venous whole blood for WBC count, RBC count, hematocrit, hemoglobin,
platelet count and WBC differential
85576QW
Accumetrics VerifyNow Aspirin Assay
Accumetrics Inc.
Qualitative assay to measure platelet aggregation
85610QW (Contact your
Medicare carrier for
claims instructions.)
1. AlereINRatio®2 PT/INR Home
Monitoring System {Prescription
Home Use}
Alere San Diego, Inc.
Aid in screening for congenital deficiencies of Factors II, V, VII, X; screen
for deficiency of prothrombin; evaluate heparin effect, coumadin or warfarin
effect; screen for Vitamin K deficiency
2. AvoSure PT System (prescription
home use)
Avocet Medical, Inc.
3. AvoSure Pro (professional use)
Avocet Medical, Inc.
4. CoaguChek PST for Prothrombin
Time
Boehringer Mannheim
Corporation
TESTS GRANTED WAIVED STATUS UNDER CLIA
This list includes updates from Change Request FFS 10418
* Newly added waived test system
19
CPT CODE(S)
TEST NAME
MANUFACTURER
USE
85610QW (cont.)
(Contact your Medicare
carrier for claims
instructions.)
5. Coag-Sense Prothrombin Time
(PT/INR) Monitoring system
(Professional use)
CoaguSense, Inc.
Aid in screening for congenital deficiencies of Factors II, V, VII, X; screen
for deficiency of prothrombin; evaluate heparin effect, coumadin or warfarin
effect; screen for Vitamin K deficiency
6. CoaguSense Self-Test
Prothrombin Time/INR
Monitoring System (Prescription
Home Use)
CoaguSense, Inc.
7. HemoSense INRatio System
HemoSense, Inc.
8. ITC Protime Microcoagulation
System for Prothrombin Time
International Technidyne
Corporation (ITC)
9. International Technidyne ProTime
Microcoagulation System
(ProTime 3 Cuvette) Prescription
Home Use
International Technidyne
Corporation
10. International Technidyne ProTime
Microcoagulation System
(ProTime 3 Cuvette) Professional
Use
International Technidyne
Corporation
11. Lifescan Harmony INR
Monitoring System -- Prescription
Home Use and Professional Use
Lifescan, Inc.
12. Roche/Boehringer Mannheim
CoaguChek System for
Professional Use
Roche Diagnostics/
Boehringer Mannheim
Corporation
13. Roche Diagnostics Coaguchek
PST
Roche Diagnostics
14. Roche Diagnostics Coagu Chek S
Systems Test (for prothrombin
time)
Roche Diagnostics
15. Roche Diagnostics CoaguChek XS
Roche Diagnostics
16. Roche Diagnostics CoaguChek XS
Plus System
Roche Diagnostics
TESTS GRANTED WAIVED STATUS UNDER CLIA
This list includes updates from Change Request FFS 10418
* Newly added waived test system
20
CPT CODE(S)
TEST NAME
MANUFACTURER
USE
86294QW
1. Bion Diagnostic Sciences BTA
stat Test (for home use)
Bion Diagnostic Sciences,
Inc.
Immunoassay for the qualitative detection of bladder tumor associated
antigen in urine of persons diagnosed with bladder cancer, and used as an
aid in the management of bladder cancer patients
2. LifeSign Status BTA
Polymedco, Inc.
86308QW
Screening test for mononucleosis
(mono) categorized as waived
complexity. Refer to the FDA website
http://www.accessdata.fda.gov/scripts/
cdrh/cfdocs/cfClia/analyteswaived.cfm
for the currently waived test systems.
Various
Qualitative screening test for the presence of heterophile antibodies in
human whole blood, which is used as an aid in the diagnosis of infectious
mononucleosis
86318QW
Immunoassay for Helicobacter pylori
antibodies, single step method,
categorized as waived complexity.
Refer to the FDA website
http://www.accessdata.fda.gov/scripts/
cdrh/cfdocs/cfClia/analyteswaived.cfm
for the currently waived test systems.
Various
Immunoassay for rapid, qualitative detection of IgG antibodies specific to
Helicobacter pylori in whole blood
86386QW
1. Alere NMP22 BladderChek Test
(Prescription Home Use) and
(Professional Use)
Alere
Immunoassay for the qualitative detection of nuclear matrix protein NMP22
in urine for use as an aid in monitoring bladder cancer patients
2. Matritech, Inc. NMP22
BladderCheck Test for
Professional and Prescription
Home Use
Maritech, Inc.
86618QW
Wampole PreVue B. burgdorferi
Antibody Detection Assay
Wampole Laboratories
Qualitative detection of IgG/IgM antibodies to Borrelia burgdorferi
(causative agent of Lyme disease) in whole blood
86701QW
1. bioLytical INSTI HIV-1 Antibody
Test {Fingerstick Whole Blood}
BioLytical Laboratories, Inc.
Qualitative immunoassay to detect antibodies to Human Immunodeficiency
Virus Type 1 (HIV-1)
2. OraSure Technologies OraQuick
Rapid HIV-1 Antibody Test
OraSure Technologies, Inc
3. OraSure OraQuick Rapid HIV-1
Antibody Test – fingerstick and
venipuncture whole blood
OraSure Technologies, Inc.
TESTS GRANTED WAIVED STATUS UNDER CLIA
This list includes updates from Change Request FFS 10418
* Newly added waived test system
21
CPT CODE(S)
TEST NAME
MANUFACTURER
USE
86701QW(cont.)
4. Trinity Biotech Uni-Gold
Recombigen HIV Test
(Fingerstick, Venipuncture Whole
Blood)
Trinity Biotech
Qualitative immunoassay to detect antibodies to Human Immunodeficiency
Virus Type 1 (HIV-1)
86780QW
Diagnostics Direct LLC Syphilis
Health Check {FingerStick Whole
Blood}
Diagnostics Direct LLC
Immunochromatographic assay for the detection of Treponema pallidum
(syphilis) antibodies in whole blood
G0433QW
1. OraSure OraQuick Advance Rapid
HIV-1/2 Antibody Test {oral fluid,
fingerstick whole blood and
venipuncture whole blood}
OraSure Technologies, Inc.
Qualitative immunoassay to detect antibodies to Human Immunodeficiency
Virus Type 1 (HIV-1) and Type 2 (HIV-2) in fingerstick whole blood ,
venipuncture whole blood and/or oral fluid specimens
2. OraSure Technologies OraQuick
In-Home HIV Test {Oral Fluid}
OraSure Technologies, Inc.
3. Chembio Diagnostic Systems, Inc,
DPP HIV 1/2 Assay {Oral Fluid}
Chembio Diagnostic
Systems, Inc.
4. Clearview Complete HIV 1/2
{Fingerstick Venipuncture, whole
blood}
Chembio Diagnostic
Systems, Inc.
86803QW,
G0472QW
OraQuick HCV Rapid Antibody Test
and OraQuick Visual Reference Panel
Orasure Technologies Inc.
Qualitative immunoassay to detect antibodies to hepatitis C virus in
fingerstick whole blood and venipuncture whole blood specimens
87077QW
1. Ballard Medical Products CLOtest
Ballard Medical Products
Presumptive identification of Helicobacter pylori in gastric biopsy tissue,
which has been shown to cause chronic active gastritis (ulcers)
2. Delta West CLOtest
Delta West
Tri-Med Specialties
3. GI Supply HP-FAST
Mycoscience Labs, Inc.
4. GI Supply, Div. Chek-Med
Systems HP One
GI Supply
5. Jant Accutest Rapid Urease test
(H. pylori detection)
ARJ Medical, Inc.
6. Medical Instruments Corporation
Pronto Dry H. pylori
Medical Instruments
Corporation
7. Serim Pyloritek Test Kit
Serim
TESTS GRANTED WAIVED STATUS UNDER CLIA
This list includes updates from Change Request FFS 10418
* Newly added waived test system
22
CPT CODE(S)
TEST NAME
MANUFACTURER
USE
87210QW
1. Stesans Maybe?Mom Mini
Ovulation Microscope
LEC Associates
Detects ferning pattern in saliva which is used in the determination of
ovulation (optimal for conception)
2. O2 Unlimited Donna Ovulation
Tester
O2 Unlimited Corp.
87338QW
Meridian Bioscience Immunocard
STAT! HpSA (Stool)
Meridian Bioscience, Inc.
Immunoassay for rapid, qualitative detection of Helicobacter pylori antigens
in stool
87389QW[from
December 5, 2014 to
December 31, 2014],
87806QW [on and after
January 1, 2015],
G0475QW [on and after
January 1, 2017]
Orgenics, Alere Determine HIV-1/2
Ag/Ab Combo {fingerstick Whole
Blood}
Detects antigen to HIV-1, and antibodies to HIV-1 and HIV-2 in whole
blood
87449QW
ZymeTx Zstatflu Test
Zymetx, Inc.
Qualitative determination of influenza types A and B from throat swab
specimens that does not differentiate between types A and B
87502QW
1. Alere i Influenza A & B Test
{Direct Nasal swab only}
Alere Scarborough, Inc.
Differential and qualitative detection of Influenza A and Influenza B viral
nucleic acids using isothermal nucleic acid amplification technology
2. RocheMolecular, cobas Liat
System (cobas Liat Influenza A/B
Assay)
IQuum, Inc.
Real-time RT-PCR assay for detection and discrimination of Influenza A
and Influenza B in nasopharyngeal swab specimens
87631QW
1. Cepheid Gene Xpert Xpress
System (Xpert Flu+RSV Xpress)
Cepheid
Detection of influenza A, influenza B and respiratory syncytial virus (RSV)
viral RNA by reverse transcriptase polymerase chain reaction assay
2. Roche Molecular, cobas Liat
System cobas Liat Influenza A/B
& RSV Assay
IQUUM, INC.
87633QW
BioFire Diagnostics, FilmArray 2.0 EZ
Configuration Instrument (Viral and
Bacterial Nucleic
Acids){Nasopharyngeal Swabs}
BioFire Diagnostics, LLC
Multiplexed nucleic acid test for detection and identification of multiple
respiratory pathogen nucleic acids in nasopharyngeal swabs
87634QW
Alere i System Respiratory Syncytial
Virus
Alere Scarborough, Inc.
Qualitative detection of RSV viral RNA in direct nasopharyngeal swabs and
nasopharyngeal swabs eluted in viral transport media utilizing isothermal nucleic
acid amplification technology
TESTS GRANTED WAIVED STATUS UNDER CLIA
This list includes updates from Change Request FFS 10418
* Newly added waived test system
23
CPT CODE(S)
TEST NAME
MANUFACTURER
USE
87651QW
1. Alere i Instrument
Alere Scarborough, Inc.
Detection of Group A Strep bacterial nucleic acids utilizing isothermal
nucleic acid amplification technology
2. Roche Molecular, cobas Liat
System
IQuum, Inc.
Detection of Streptococcus group A utilizing nucleic acid purification and
polymerase chain reaction (PCR) technology (automation and integration of
sample purification, nucleic acid amplification, and detection of the target
sequence using real-time PCR) to detect Streptococcus pyogenes
87804QW
Quidel QuickVue® Influenza Test
Quidel Corporation
Qualitative detection of influenza type A and type B antigens from nasal
swab, nasal wash or nasal aspirate specimens that does not differentiate
between influenza types A and B
87804QW
1. Alere Influenza A & B Test (For
use with nasal Swabs only.)
Alere Scarborough, Inc.
Qualitative detection of influenza type A and type B antigens from nasal
swab, nasopharyngeal (NP) swab, nasal wash, nasal aspirate or nasal
specimens that does differentiate between influenza types A and B
2. Alere BinaxNow Influenza A & B
Card {Nasopharyngeal (Np) Swab
and Nasal Wash/Aspirate
Specimens}
Alere Scarborough, Inc.
3. BD Veritor System for Rapid
Detection of Flu A+B (For use
with nasal and nasopharyngeal
swabs) {Includes a Reader}
Becton, Dickinson and
Company
4. BinaxNow Influenza A & B Test,
K092223
Binax, Inc
5. BinaxNOW® Influenza A & B
Test in nasopharyngeal (NP) swab
and nasal wash/aspirate
specimens, K041049
Binax, Inc.
6. BinaxNOW Influenza A & B Test
{Nasopharyngeal (Np) Swab and
Nasal Wash/Aspirate Specimens},
K053126
Binax, Inc.
7. BinaxNOW Influenza A & B Test
{Nasopharyngeal (Np) Swab and
Nasal Wash/Aspirate Specimens
and Nasal Specimens (NS)}
Binax, Inc.
TESTS GRANTED WAIVED STATUS UNDER CLIA
This list includes updates from Change Request FFS 10418
* Newly added waived test system
24
CPT CODE(S)
TEST NAME
MANUFACTURER
USE
87804QW (cont.)
8. BioSignFlu A+B {Nasal and
nasopharyngeal swabs}
Princeton Biomeditech
Corporation
Qualitative detection of influenza type A and type B antigens from nasal
swab, nasopharyngeal (NP) swab, nasal wash, nasal aspirate or nasal
specimens that does differentiate between influenza types A and B
9. Henry Schein OneStep+ Influenza
A&B Test
Alere Scarborough, Inc.
10. LifeSign LLC, Status Flu A+B
{Nasal and Nasopharyngeal
Swabs}
Princeton Biomeditech
Corporation
11. McKesson Consult Influenza A &
B {Nasal and Nasopharyngeal
Swabs}
Princeton Biomeditech
Corporation
12. OraSure QuickFlu Rapid A+B
Test {Nasal and Nasopharyngeal
Swabs}
Princeton Biomeditech
Corporation
13. PBM Princeton Biomedical Corp.
ImmunoCard STAT! Flu A&B
{Nasal and Nasopharyngeal
Swabs}
Princeton Biomeditech
Corporation
14. Quidel Quickvue Influenza A+B
Test
Quidel Corporation
15. Quidel Sofia 2 {Sofia Influenza
A+B FIA}
Quidel Corporation
16. Sekisui Diagnostics LLC, OSOM
Ultra Flu A&B Test {Nasal and
Nasopharyngeal Swabs}
Princeton Biomeditech
Corporation
17. Sofia Analyzer and Influenza A+B
FIA
Quidel Corporation
18. Sofia Analyzer and Influenza A+B
FIA (for user with nasal swabs and
nasopharyngeal swabs)
Quidel Corporation
87804QW
1. Binax Now Flu A Test
Binax, Inc.
Qualitative detection of influenza type A antigen in nasopharyngeal
specimens
2. BTNX, Inc. Rapid Response
Influenza A Test Cassette
SA Scientific, Inc.
TESTS GRANTED WAIVED STATUS UNDER CLIA
This list includes updates from Change Request FFS 10418
* Newly added waived test system
25
CPT CODE(S)
TEST NAME
MANUFACTURER
USE
87804QW (cont.)
3. EarlyDetect Pro Influenza A Test
SA Scientific, Inc.
Qualitative detection of influenza type A antigen in nasopharyngeal
specimens
4. SA Scientific SAS Influenza A
Test
SA Scientific, Inc.
87804QW
1. Binax Now Flu B Test
Binax, Inc.
Qualitative detection of influenza type B antigen in nasopharyngeal
specimens
2. BTNX, Inc. Rapid Response
Influenza BTest Cassette
SA Scientific, Inc.
3. EarlyDetect Pro Influenza B Test
SA Scientific, Inc.
4. SA Scientific SAS Influenza B
Test
SA Scientific, Inc.
87807QW
1. Alere BinaxNOW RSV Card
Alere Scarborough, Inc.
Rapid immunoassay for the qualitative detection of RSV antigen
2. BD Veritor System for Rapid
Detection of RSV (For use with
nasopharyngeal
specimens){Includes a reader}
Becton, Dickinson and
Company
3. Binax NOW RSV Test (K021687)
Binax, Inc.
4. Binax NOW RSV Test
(K032166/A005)
Binax, Inc.
5. Fisher Scientific Sure-Vue RSV
Test
SA Scientific, Inc.
6. Integrated Biotechnology Quick
Lab RSV Test
Integrated Biotechnology
Corp.
7. Quidel Quick Vue RSV Test
Quidel Corporation
8. SA Scientific SAS RSV Alert
SA Scientific, Inc.
9. Sofia RSV
Quidel Corp.
10. Quidel Sofia 2 {Sofia RSV FIA}
Quidel Corp.
87808QW
1. Genzyme OSOM Trichomonas
Rapid Test
Genzyme Corp.
Immunoassay for the qualitative detection of Trichomonas vaginalis
antigens from vaginal swabs
2. Sekisui Diagnostics, LLC OSOM
Trichomonas Rapid Test
Genzyme Corp.
TESTS GRANTED WAIVED STATUS UNDER CLIA
This list includes updates from Change Request FFS 10418
* Newly added waived test system
26
CPT CODE(S)
TEST NAME
MANUFACTURER
USE
87809QW
1. AdenoPlus (human eye fluid)
Rapid Pathogen Screening,
Inc.
Immunochromatographic test for the qualitative detection of adenoviral
antigens from eye fluid
2. Quidel, AdenoPlus {Tear fluid}*
Quidel Corp.
3. Rapid Pathogen Screening RPS
Adeno Detector
Rapid Pathogen Screening
Immunochromatographic test for the qualitative detection of adenoviral
antigens from eye fluid
87880QW
Streptococcus group A antigen
detection by immunoassay with direct
optical observation categorized as
waived complexity. Refer to the FDA
website
http://www.accessdata.fda.gov/scripts/
cdrh/cfdocs/cfClia/analyteswaived.cfm
for the currently waived test systems.
Various
Rapidly detects GAS antigen from throat swabs and used as an aid in the
diagnosis of GAS infection, which typically causes strep throat, tonsillitis,
and scarlet fever
87899QW
Meridian Bioscience Immunocard
STAT! HpSA {Stool}
Meridian Bioscience, Inc.
Immunoassay for the qualitative detection of Helicobacter pylori antigens
in stool specimens
87905QW
Gryphus Diagnostics BVBlue
Gryphus Diagnositcs, LLC
Enzyme activity test for the detection of sialidase activity in vaginal fluid
specimens, an enzyme produced by bacterial pathogens such as Gardnerella
vaginais, Bacteroides spp., Prevotella spp., and Mobiluncus spp.
89300 QW (This test
may not be covered in
all instances. Contact
your Medicare carrier
for claims instructions)
1. Embryotech Laboratories
FertilMARQ Home Diagnostic
Screening Test for Male Infertility
Embryotech Laboratories,
Inc.
Screening test to measure sperm concentration
2. SpermCheck Vasectomy
Princeton BioMeditech Corp.
Detects sperm in semen following a vasectomy
89321QW
Fertell Male Fertility Test
Genosis Ltd.
Determines whether the concentration of motile sperm is above a cut-off
level of 10 million motile sperm cells per ml
