# K981281: Elecsys Calcheck Ferritin

- Pathway: 510(k) (Traditional)
- Applicant: Roche Diagnostics GmbH
- Decided: Apr 24, 1998 after 16 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.
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. The FDA summary names its predicate without a number.
- (no number) Elecsys® CalCheck™ TSH: named in the summary without a submission number

## Most influential descendants
- K102267: Elecsys Ferritin Calcheck 5 (2010), 1 descendant of its own
- K143376: ADIVA Centaur Progesterone Master Curve Material (MCM), ADIVA Centaur Ferritin Master Curve Material (2014), 0 descendants of its own

## Indications for use
Elecsys CalCheck Ferritin calibration verification solutions comprise three levels - low, mid, and high - each with a defined Ferritin concentration. The low solution concentration is near the lower detection limit of the assay. The mid solution is in the middle or at the clinically critical point of the measuring range. The high solution is near the upper limit of the measuring range. The Elecsys CalCheck Ferritin is intended for use in periodic verification of the calibration of the Elecsys Ferritin assay.

Source page: https://510kreport.com/device/K981281
Methodology: https://510kreport.com/methodology