# K980028: Alt (GPT) Liquid Stable 2 Vial - Incorporating Dynamic Stabilization Technology - (DST)

- Pathway: 510(k) (Traditional)
- Applicant: Trace America, Inc.
- Decided: Feb 2, 1998 after 28 days
- Product code: CKA (Nadh Oxidation/Nad Reduction, Alt/Sgpt)
- Device class: 1
- Regulation: 21 CFR 862.1030
- 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
Intended for the the In Vitro, quantitative determination of ALT (GPT) activity in human serum on automated chemistry analyzers. “Alanine amino transferase (ALT/SGPT) measurements are used in the diagnosis and treatment of certain types of liver (e.g. viral hepatitis and cirrhosis) and heart diseases.” CFR 862.1030

Source page: https://510kreport.com/device/K980028
Methodology: https://510kreport.com/methodology