# K191296: Pointe Scientific Creatinine Kinase (CK) Reagent Set

- Pathway: 510(k) (Traditional)
- Applicant: Medtest DX
- Decided: Aug 11, 2020 after 455 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 K043202 (2004). 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)
- K043202: Olympus Creatine Kinase Reagent OSR6179/OSR6279, Olympus America, Inc. (2004) Summary page 4.

## Indications for use
For the quantitative determination of creatine kinase activity in serum and plasma. Rx only. Measurements of Creatine Kinase are used in the diagnosis and treatment of myocardial infarction and muscle disease, such as progressive Duchenne-type muscular dystrophy.

Source page: https://510kreport.com/device/K191296
Methodology: https://510kreport.com/methodology