# K961114: Ast Incorporating DST

- Pathway: 510(k) (Traditional)
- Applicant: Trace Scientific, Ltd.
- Decided: May 23, 1996 after 64 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.
2 later devices descend from it; 2 cite it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K992801: Sigma Diagnostics Infinity Astbun Reagent, Model 51-25, Sigma Diagnostics Infinity Ast Reagent, Models 51-100P,51-500P,5 (1999), 0 descendants of its own
- K980666: Infinity Ast Reagent (Procedure NO. 51) (1998), 0 descendants of its own

Source page: https://510kreport.com/device/K961114
Methodology: https://510kreport.com/methodology