# K962549: Vidas Creatine Kinase MB Assay 30-421

- Pathway: 510(k) (Traditional)
- Applicant: Biomerieux Vitek, Inc.
- Decided: Aug 30, 1996 after 63 days
- Product code: JHX (Fluorometric Method, 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.
2 later devices descend from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Ciba-Corning Magic Lite CK-MB assay: named in the summary without a submission number

## Most influential descendants
- K120326: AQT90 Flex CKMB Test Kit, AQT90 Flex LQC Multi-Check, Levels 1-3, AQT90 Flex CKMB Cal Cartridge (2012), 1 descendant of its own
- K163462: AQT90 FLEX Myo Test Kit, AQT90 FLEX CKMB Test Kit, AQT90 FLEX (2017), 0 descendants of its own

## Indications for use
The VIDAS CKMB assay determines the concentration of creatine kinase MB isoenzyme in serum or plasma (heparin or EDTA).

Source page: https://510kreport.com/device/K962549
Methodology: https://510kreport.com/methodology