# K981221: Aspartate Aminotransferase Activated ( Ast Activated)

- Pathway: 510(k) (Traditional)
- Applicant: Abbott Laboratories
- Decided: Apr 23, 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.
1 later device descends from it; 1 cites 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)
- K861792: Twin Got-Ast Ifcc/GPT-Alt Ifcc, Boehringer Mannheim Corp. (1986) Summary page 2.

## Most influential descendants
- K071525: Activated Aspartate Aminotransferase (2008), 0 descendants of its own

## Indications for use
The Aspartate Aminotransferase Activated is used for the quantitation of aspartate aminotransferase (also known as a serum glutamic oxaloacetic transferase or SGOT) in human serum and plasma. Aspartate aminotransferase measurements are used in the diagnosis and treatment of certain types of liver and heart disease.

Source page: https://510kreport.com/device/K981221
Methodology: https://510kreport.com/methodology