# K974833: CK-Nac Reagent

- Pathway: 510(k) (Traditional)
- Applicant: Intersect Systems, Inc.
- Decided: Feb 13, 1998 after 51 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
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 Intersect CK Reagent is an in-vitro diagnostic product intended for use in the quantitative determination of creatine kinase in human serum.

Source page: https://510kreport.com/device/K974833
Methodology: https://510kreport.com/methodology