# K973030: Vitros Immunodiagnostics Products/CK-MB Reagent Pack (Gem.1300)/CK-MB Calibrators (Gem.C300)

- Pathway: 510(k) (Traditional)
- Applicant: Johnson & Johnson Clinical Diagnostics, Inc.
- Decided: Sep 4, 1997 after 21 days
- Product code: JJY (Multi-Analyte Controls, All Kinds (Assayed))
- Device class: 1
- Regulation: 21 CFR 862.1660
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
2 later devices descend 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)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K993068: Vitros Immunodiagnostic Products CK-MB Reagent Pack ; Vitros Immunodiagnostic Products CK-MB Calibrators (1999), 1 descendant of its own
- K212648: VITROS Immunodiagnostic Products CK-MB Reagent Pack (2022), 0 descendants of its own

## Recalls of this device
- Apr 3, 2013 · Class III · Z-1337-2013: Internal testing demonstrated that opened-reconstituted VITROS CK-MB Calibrators stored at -20 degrees Celsius (-4 degrees Farenheit) generated invalid calibrations that were detected by positively bi

## 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 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. VITROS Cardiology Controls - For in vitro use in monitoring the performance of the VITROS Immunodiagnostic System when used for the measurement of CK-MB.

Source page: https://510kreport.com/device/K973030
Methodology: https://510kreport.com/methodology