# K983131: AST

- Pathway: 510(k) (Traditional)
- Applicant: Abbott Laboratories
- Decided: Sep 28, 1998 after 20 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
Longest line of descent: 1 generation back to K861792 (1986). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K861792: Twin Got-Ast Ifcc/GPT-Alt Ifcc, Boehringer Mannheim Corp. (1986) Summary page 1.

## Indications for use
The Aspartate Aminotransferase assay is used for the quantitation of aspartate aminotransferase in human serum or plasma. Measurement of aspartate aminotransferase is used in the diagnosis and treatment of certain types of liver and heart disease.

Source page: https://510kreport.com/device/K983131
Methodology: https://510kreport.com/methodology