# K980900: N-Assay CPK-L

- Pathway: 510(k) (Traditional)
- Applicant: Crestat Diagnostics, Inc.
- Decided: Mar 26, 1998 after 16 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
Longest line of descent: 1 generation back to K781719 (1978). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K781719: CPK Reagent Set, Nad Reduction, Medical Analysis Systems, Inc. (1978) Summary page 2.

## Indications for use
The intended use for the N-ASSAY CPK-L Reagent is for the quantitative determination of serum creatine phosphokinase (CPK) activity in human serum in the diagnosis and treatment of myocardial infarction and muscle diseases such as muscular dystrophy.

Source page: https://510kreport.com/device/K980900
Methodology: https://510kreport.com/methodology