# K980666: Infinity Ast Reagent (Procedure NO. 51)

- Pathway: 510(k) (Traditional)
- Applicant: Sigma Diagnostics, Inc.
- Decided: Mar 20, 1998 after 28 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 K961114 (1996). 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)
- K961114: Ast Incorporating DST, Trace Scientific, Ltd. (1996) Summary page 1.

## Indications for use
Sigma Diagnostics INFINITY™ AST Reagent is a device intended to measure the activity of the enzyme aspartate amino transferase (AST) in serum. Aspartate amino transferase measurements are used in the diagnosis and treatment of certain types of liver and heart disease.

Source page: https://510kreport.com/device/K980666
Methodology: https://510kreport.com/methodology