# K080485: Aspartate Amino Transferase (Ast/Sgot) Test System, Asat (Got) FS

- Pathway: 510(k) (Traditional)
- Applicant: Diasys Diagnostics Systems GmbH
- Decided: Dec 4, 2008 after 286 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: 3 generations back to K811832 (1981). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K924244: Roche Reagent for Ast, Roche Diagnostic Systems, Inc. (1993) Summary page 2.
- K990460: Calibrator for Automated Systems (C.F.a.S.), Roche Diagnostics Corp. (1999) Summary page 2.
- K042389: Modification to Precinorm Universal Plus and Precipath Universal Plus Control Sera, Roche Diagnostics Corp. (2004) Summary page 2.

## Indications for use
ASAT (GOT) FS The ASAT (GOT) FS assay is intended for quantitative in vitro diagnostic determination of the activity of the enzyme aspartate amino transferase (AST) in human serum and lithium heparin plasma on the Hitachi 917 instrument. Measurement of aspartate amino transferase levels aids in the diagnosis and treatment of certain types of liver and heart disease. TruCal U For In vitro diagnostic use on the Hitachi 917 instrument. TruCal U is used as a calibrator for the DiaSys ASAT (GOT) FS assay. TruLab N and TruLab P Controls For in vitro diagnostic use for quantitative testing on the Hitachi 917 instrument. TruLab N and TruLab P control sera are used to monitor accuracy and precision for the DiaSys ASAT (GOT) FS assay.

Source page: https://510kreport.com/device/K080485
Methodology: https://510kreport.com/methodology