# CKA: Nadh Oxidation/Nad Reduction, Alt/Sgpt

- Device class: 1; regulation: 21 CFR 862.1030; FDA's rule: 510(k) exempt
- FDA decisions: 127
- Recalls: 10 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026; MAUDE to Sep 30, 2026

## Decisions per year (last 10)
- 1993: 2
- 1994: 5
- 1995: 4
- 1996: 1
- 1997: 3
- 1998: 2
- 2002: 1
- 2006: 1
- 2012: 1
- 2013: 1

## Most-cited predicates
- K883181: Synchron CX4/CX5 Clinical Chemistry Analyzer Reage (1988), cited by 3
- K861792: Twin Got-Ast Ifcc/GPT-Alt Ifcc (1986), cited by 3
- K113382: Ace Alt Reagent (2012), cited by 2
- K974003: Alanine Aminotransferase-SL Assay Catalogue Number 318-10, 318-30 (1997), cited by 1
- K973869: Trace Reagent Line for the Cobas Mira (1998), cited by 1

Source page: https://510kreport.com/product-code/CKA
Data by year (CSV): https://510kreport.com/product-code/CKA.csv