# K834502: CK-Nac Reagent

- Pathway: 510(k) (Traditional)
- Applicant: Roche Diagnostic Systems, Inc.
- Decided: Feb 27, 1984 after 68 days
- Product code: CGS (Nad Reduction/Nadh Oxidation, Cpk Or Isoenzymes)
- Device class: 2
- Regulation: 21 CFR 862.1215
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
8 later devices descend from it; 4 cite it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K081731: Dimension Cki Flex Reagent Cartridge, Dimension Mbi Flex Reagent Cartridge, and Cki/Mbi Calibrator, Models DF38, DF32 (2008), 3 descendants of its own
- K083579: Dimension Vista System Enzyme 6 Calibrator, Model KC360 (2009), 1 descendant of its own
- K992140: Piccolo Metlyte 7 Reagent Disc (1999), 1 descendant of its own
- K200865: Piccolo Potassium Test System (2021), 0 descendants of its own
- K160724: ADVIA Chemistry Creatine Kinase (CK_L) Assay, ADVIA Chemistry Enzyme 3 Calibrator (2016), 0 descendants of its own

Source page: https://510kreport.com/device/K834502
Methodology: https://510kreport.com/methodology