# K993068: Vitros Immunodiagnostic Products CK-MB Reagent Pack ; Vitros Immunodiagnostic Products CK-MB Calibrators

- Pathway: 510(k) (Special)
- Applicant: Ortho-Clinical Diagnostics
- Decided: Oct 4, 1999 after 21 days
- Product code: JHX (Fluorometric Method, Cpk Or Isoenzymes)
- Device class: 2
- Regulation: 21 CFR 862.1215
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K973030 (1997). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K973030: Vitros Immunodiagnostics Products/CK-MB Reagent Pack (Gem.1300)/CK-MB Calibrators (Gem.C300), Johnson & Johnson Clinical Diagnostics, Inc. (1997) Summary page 3.

## Most influential descendants
- K212648: VITROS Immunodiagnostic Products CK-MB Reagent Pack (2022), 0 descendants of its own

## Recalls of this device
- Nov 26, 2003 · Not classified · Z-0298-04: Reagent packs may contain wells that produce a low light signal that could result in calibration failures or negatively biased results.

## Indications for use
VITROS CK-MB Reagent Pack - Creatine phosphokinase/creatine kinase or isoenzymes test systems is a device intended to measure the enzyme creatine phosphokinase or its isoenzymes in serum and plasma in the diagnosis and treatment of myocardial infarction. VITROS CK-MB Calibrators - For in vitro use in the calibration of the VITROS Immunodiagnostic System for the quantitative measurement of CK-MB in human serum and plasma.

Source page: https://510kreport.com/device/K993068
Methodology: https://510kreport.com/methodology