# K102267: Elecsys Ferritin Calcheck 5

- Pathway: 510(k) (Traditional)
- Applicant: Roche Diagnostics
- Decided: Sep 10, 2010 after 32 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
Longest line of descent: 1 generation back to K981281 (1998). 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)
- K981281: Elecsys Calcheck Ferritin, Roche Diagnostics GmbH (1998) Summary page 1.

## Most influential descendants
- K143376: ADIVA Centaur Progesterone Master Curve Material (MCM), ADIVA Centaur Ferritin Master Curve Material (2014), 0 descendants of its own

## Indications for use
The Elecsys Ferritin 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 Ferritin reagent on the indicated Elecsys and cobas e immunoassay analyzers.

Source page: https://510kreport.com/device/K102267
Methodology: https://510kreport.com/methodology