# K003158: Roche Diagnostics CK-MB

- Pathway: 510(k) (Traditional)
- Applicant: Roche Diagnostics Corp.
- Decided: Dec 18, 2000 after 69 days
- Product code: JHW (U.V. Method, Cpk 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.
9 later devices descend from it; 6 cite it directly.
0 of 10 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
- K162526: Creatine Kinase-MB (2017), 0 descendants of its own
- K160724: ADVIA Chemistry Creatine Kinase (CK_L) Assay, ADVIA Chemistry Enzyme 3 Calibrator (2016), 0 descendants of its own
- K123977: Randox Liquid CK-MB, Randox CK-MB Calibrator (2013), 0 descendants of its own

Source page: https://510kreport.com/device/K003158
Methodology: https://510kreport.com/methodology