NAO · Test, Carbohydrate Deficient Transferrin
Clinical Chemistry · 21 CFR 862.1360 · Class 1
Overview
| Product Code | NAO |
|---|---|
| Device Name | Test, Carbohydrate Deficient Transferrin |
| Regulation | 21 CFR 862.1360 |
| Device Class | Class 1 |
| Review Panel | Clinical Chemistry |
Identification
A gamma-glutamyl transpeptidase and isoenzymes test system is a device intended to measure the activity of the enzyme gamma-glutamyl transpeptidase (GGTP) in plasma and serum. Gamma-glutamyl transpeptidase and isoenzymes measurements are used in the diagnosis and treatment of liver diseases such as alcoholic cirrhosis and primary and secondary liver tumors.
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 862.9.
Cleared Devices (3)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K060677 | N LATEX CDT | Dade Behring, Inc. | Aug 25, 2006 | SESE |
| K001943 | CHRONALCO I.D.CDT (CARBOHYDRATE DEFICIENT TRANSFERRIN) ASSAY | Sangui Biotech, Inc. | Aug 23, 2000 | SESE |
| K992502 | AXIS %CDT TURBIDIMETRIC IMMUNOASSAY | Axis | Dec 21, 1999 | SESE |
Top Applicants
- Sangui Biotech, Inc. — 1 clearance
- Dade Behring, Inc. — 1 clearance
- Axis — 1 clearance
