# K013698: Ast (Sgot)

- Pathway: 510(k) (Traditional)
- Applicant: Jas Diagnostics, Inc.
- Decided: Dec 21, 2001 after 44 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
Intended for the In Vitro, quantitative determination of aspartate amino transferase (AST) in human serum on automated chemistry analyzers. Aspartate amino transferase measurements are used in the diagnosis and treatment of certain types of liver and heart diseases.

Source page: https://510kreport.com/device/K013698
Methodology: https://510kreport.com/methodology