# K973157: Liquid GGT (Gamma Glutamyl Transferase) Reagent Set

- Pathway: 510(k) (Traditional)
- Applicant: Pointe Scientific, Inc.,
- Decided: Oct 10, 1997 after 49 days
- Product code: JQB (Kinetic Method, Gamma-Glutamyl Transpeptidase)
- Device class: 1
- Regulation: 21 CFR 862.1360
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
This product is to be used in a diagnostic laboratory setting, by qualified laboratory technologists, for the quantitative kinetic determination of gamma glutamy! transferase in serum. lt is intended for in vitro diagnostic use only. The determination of gamma glutamyl transferase in serum is most commonly performed for the diagnosis and treatment of liver diseases such as alcoholic cirrhosis and secondary liver tumors.

Source page: https://510kreport.com/device/K973157
Methodology: https://510kreport.com/methodology