# K022757: Spife CK Kit, Model 3332, 3333

- Pathway: 510(k) (Traditional)
- Applicant: Helena Laboratories
- Decided: Oct 11, 2002 after 52 days
- Product code: JHY (Colorimetric 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.
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. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The SPIFE CK Kit is used in the identification and quantitation of serum creatine kinase isoenzymes. This test is especially useful in detecting acute myocardial infarction (AMI) when used in conjunction with LD isoenzyme studies.

Source page: https://510kreport.com/device/K022757
Methodology: https://510kreport.com/methodology