# K212648: VITROS Immunodiagnostic Products CK-MB Reagent Pack

- Pathway: 510(k) (Traditional)
- Applicant: Ortho Clinical Diagnostics
- Decided: Jan 28, 2022 after 158 days
- Product code: JHX (Fluorometric 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
Longest line of descent: 2 generations back to K973030 (1997). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K993068: Vitros Immunodiagnostic Products CK-MB Reagent Pack ; Vitros Immunodiagnostic Products CK-MB Calibrators, Ortho-Clinical Diagnostics (1999) Summary page 4.

## Indications for use
For in vitro diagnostic use only. For the quantitative measurement of CK-MB in human serum and plasma (EDTA or heparin) using the VITROS 3600 Immunodiagnostic System. Measurements of creatine phosphokinase and its isoenzymes are used in the diagnosis and treatment of myocardial infarction and muscle diseases such as progressive, Duchenne-type muscular dystrophy.

Source page: https://510kreport.com/device/K212648
Methodology: https://510kreport.com/methodology