# K974001: Aspartate Aminotransferase-SL Assay, Catalogue Number 319-10, 319-30

- Pathway: 510(k) (Traditional)
- Applicant: Diagnostic Chemicals, Ltd.
- Decided: Nov 13, 1997 after 23 days
- Product code: CIT (Nadh Oxidation/Nad Reduction, Ast/Sgot)
- Device class: 2
- Regulation: 21 CFR 862.1100
- 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
For the quantitative determination of aspartate aminotransferase in serum. For IN VITRO diagnostic use. Elevated levels of aspartate aminotransferase result from a myocardial infarction, or hepatic disease. In cases of hepatic necrosis, elevations of AST levels occur prior to the onset of clinical symptoms such as jaundice. To a lesser extent elevated levels are indicative of discases of some internal organs.' 1. Burtis, C.A., Ashwood, E. R. (Ed.), Tietz Textbook of Clinical Chemistry, W.B. Saunders Co., Toronto pp790-791 (1994).

Source page: https://510kreport.com/device/K974001
Methodology: https://510kreport.com/methodology