# K972155: Creatine Kinase (CK)

- Pathway: 510(k) (Traditional)
- Applicant: Stanbio Laboratory
- Decided: Jul 17, 1997 after 42 days
- Product code: CGS (Nad Reduction/Nadh Oxidation, Cpk Or Isoenzymes)
- Device class: 2
- Regulation: 21 CFR 862.1215
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device 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) CK/NAC: named in the summary without a submission number

## Recalls of this device
- Oct 19, 2011 · Class III · Z-2650-2017: Linear performance information in product insert does not match that listed in the approved premarket notification

## Indications for use
Stanbio Laboratory’s Creatine Kinase (CK) Liqui-UV is a device intended to measure the activity of the enzyme creatine phosphokinase or its isoenzymes (a group of enzymes with similar biological activity) in serum. Serum creatine kinase (CK) levels have proven valuable in the assessment of cardiac and skeletal muscle diseases, including myocardial infarction and muscular dystrophy.

Source page: https://510kreport.com/device/K972155
Methodology: https://510kreport.com/methodology