TESTS GRANTED WAIVED STATUS UNDER CLIA
This list includes updates from Change Request FFS 10418
* Newly added waived test system
CPT CODE(S)
TEST NAME
MANUFACTURER
USE
ReliaLAB Inc. InstaRead Lithium
System {fingerstick or venipuncture
whole blood}
Measures lithium blood levels in whole blood
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.
Screening test for the presence/detection of any number of drug classes in
urine
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.
Screening of urine to monitor/diagnose various diseases/conditions, such as
diabetes, the state of the kidney or urinary tract, and urinary tract infections
82570QW
1. Siemens Clinitek 50 Urine
Chemistry Analyzer
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
82570QW,
84703QW
1. Siemens Clinitek Status Urine
Chemistry Analyzer
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
Diagnostics