21 CFR 862.1360 — Colorimetric Method, Gamma-Glutamyl Transpeptidase
Clinical Chemistry (CH) · Part 862 Subpart B—Clinical Chemistry Test Systems · § 862.1360
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.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| JPZ | Colorimetric Method, Gamma-Glutamyl Transpeptidase | 1 | 33 | |
| JQA | Electrophoretic, Gamma-Glutamyl Transpeptidase Isoenzymes | 1 | 0 | |
| JQB | Kinetic Method, Gamma-Glutamyl Transpeptidase | 1 | 52 | |
| NAO | Test, Carbohydrate Deficient Transferrin | 1 | 3 |
