# CIT: Nadh Oxidation/Nad Reduction, Ast/Sgot

- Device class: 2; regulation: 21 CFR 862.1100; FDA's rule: 510(k) exempt
- FDA decisions: 139
- Recalls: 9 (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)
- 1997: 3
- 1998: 8
- 1999: 5
- 2000: 1
- 2001: 3
- 2002: 1
- 2006: 1
- 2007: 2
- 2008: 2
- 2010: 1

## Most-cited predicates
- K954992: Roche Cobas Integra Reagent Cassettes (1996), cited by 7
- K924244: Roche Reagent for Ast (1993), cited by 2
- K961114: Ast Incorporating DST (1996), cited by 2
- K060318: Hepatic Enzymes on Abx Pentra 400 Clinical Chemistry Analyzer (2006), cited by 2
- K923505: Ast (Got) - Aspartate Aminotransferase (1992), cited by 1
- K001679: Vitros Chemistry Products Ast Slide and Chemistry Products Calibrator Kit 3 (2000), cited by 1
- K801118: Cobas Reagent for Ast (Sgot) (1980), cited by 1
- K894180: Abbott Ast-Activated (Liquid, List#01A54) (1989), cited by 1
- K981221: Aspartate Aminotransferase Activated ( Ast Activated) (1998), cited by 1
- K992136: Bayer Advia Integrated Modular System (Ims) (1999), cited by 1

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