# K071580: Ast/Got (Ifcc), Pyridoxal Phosphate, Ecal, Nortrol and Abtrol

- Pathway: 510(k) (Traditional)
- Applicant: Thermofisher Scientific OY
- Decided: Oct 3, 2007 after 117 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 K992136 (1999). 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)
- K992136: Bayer Advia Integrated Modular System (Ims), Bayer Corp. (1999) Summary page 3.

## Indications for use
AST I GOT (IFCC) The AST/ GOT (IFCC) test system is intended for quantitative in-vitro diagnostic determination of the activity of the enzyme aspartate amino transferase (AST) (also known as a serum glutamic oxaloacetic transferase or SGOT) in serum and plasma on T60 instrument. Measurement of aspartate amino transferase levels aids in tile diagnosis and treatment of certain types of liver and heart disease Auxiliary product: Pyridoxal Phosphate Auxiliary reagent for in vitro diagnostic use in the quantitative determination of AST (GOT) codes 981363 and 981771, activity according to the IFCC recommendations with 3-reagent method on T60 instrument. eCal! For in vitro diagnostic use on T60 instrument. eCal is used as a calibrator for enzyme tests using methods defined by Thermo Fisher Scientific Oy Nortrol For in vitro diagnostic use for quantitative testing on T60 instrument. Nortrol is a control serum to monitor precision of the analytes listed in the separate Nortrol value sheet. The given values are valid for T60 Clinical Chemistry Instruments using methods defined by Thermo Fisher Scientific Oy. Abtrol For in vitro diagnostic use for quantitative testing on T60 instrument. Abtrol is a control serum to monitor precision of the analytes listed in the separate Abtrol value sheet. The given values are valid for T60 Clinical Chemistry Instruments using methods defined by Thermo Fisher Scientific Oy.

Source page: https://510kreport.com/device/K071580
Methodology: https://510kreport.com/methodology