# K071525: Activated Aspartate Aminotransferase

- Pathway: 510(k) (Traditional)
- Applicant: Abbott Laboratories
- Decided: Mar 19, 2008 after 289 days
- Product code: CIT (Nadh Oxidation/Nad Reduction, Ast/Sgot)
- Device class: 2
- Regulation: 21 CFR 862.1100
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K861792 (1986). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K981221: Aspartate Aminotransferase Activated ( Ast Activated), Abbott Laboratories (1998) Summary page 2.

## Recalls of this device
- Jun 30, 2008 · Not classified · Z-1447-2012: This letter is to inform you that some samples may generate A-AST results of less than (<) 5 U/L or results within the reference range when actual concentration exceeds the non-Flex linearity of 1985 

## Indications for use
Activated Aspartate Aminotransferase (AST/SGOT) test system is a device intended to measure the activity of the enzyme aspartate aminotransferase (AST) (also known as a serum glutamic oxaloacetic transferase or SGOT) in 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/K071525
Methodology: https://510kreport.com/methodology