# K974003: Alanine Aminotransferase-SL Assay Catalogue Number 318-10, 318-30

- Pathway: 510(k) (Traditional)
- Applicant: Diagnostic Chemicals, Ltd.
- Decided: Dec 5, 1997 after 45 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.
1 later device descends from it; 1 cites it directly.
0 of 2 devices 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.

## Most influential descendants
- K120945: Hitachi Clinical Analyzer S Test Reagent Cartridge Alt, Hitachi Clinical Analyzer S Test Reagent Cartridge Ast (2013), 0 descendants of its own

## Indications for use
For the quantitative determination of alanine aminotransferase in serum. For IN VITRO diagnostic use. Elevated levels of alanine aminotransferase result from a myocardial infarction, or hepatic disease. In cases of hepatic necrosis, elevations of ALT levels occur prior to the onset of clinical symptoms such as jaundice. To a lesser extent levels are indicative of diseases of some internal organs.' 1. Burtis, C.A., Ashwood, E.R. (Ed.), Tietz Textbook of Clinical Chemistry, W.B. Saunders Co., Toronto, p 790-791 (1994).

Source page: https://510kreport.com/device/K974003
Methodology: https://510kreport.com/methodology