# K093582: Elecsys CK-MB Calcheck 5

- Pathway: 510(k) (Traditional)
- Applicant: Roche Diagnostics
- Decided: Mar 29, 2010 after 130 days
- Product code: JJX (Single (Specified) Analyte Controls (Assayed And Unassayed))
- Device class: 1
- Regulation: 21 CFR 862.1660
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
5 later devices descend from it; 1 cites it directly.
0 of 6 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
- K133284: Elecsys CK-MB Calcheck 5 (2013), 4 descendants of its own
- K142127: Elecsys Estradiol Iii Calcheck 5 (2014), 3 descendants of its own
- K150955: Elecsys Progesterone III Cal Check 5 (2015), 2 descendants of its own
- K162173: Elecsys CYFRA 21-1 CalCheck 5 (2017), 0 descendants of its own
- K160729: Elecys BRAHMS PCT, Elecys BRAHMS PCT CalCheck 5 (2016), 0 descendants of its own

## Indications for use
The Elecsys CK-MB CalCheck 5 is an assayed control for use in calibration verification and for use in the verification of the assay range established by the Elecsys CK-MB reagent on the indicated Elecsys and cobas e immunoassay analyzers.

Source page: https://510kreport.com/device/K093582
Methodology: https://510kreport.com/methodology