# K000576: Elecsys Cortisol Calcheck

- Pathway: 510(k) (Traditional)
- Applicant: Roche Diagnostics Corp.
- Decided: Mar 21, 2000 after 28 days
- Product code: JIX (Calibrator, Multi-Analyte Mixture)
- Device class: 2
- Regulation: 21 CFR 862.1150
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 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
- K143194: ADIVA Centaur Prolactin Master Curve Material (MCM), ADIVA Centaur Cortisol Master Curve Material (MCM) (2014), 0 descendants of its own

## Indications for use
Elecsys® Cortisol CalCheck calibration verification solutions comprise three levels - low, mid, and high - each with a defined Cortisol concentration. The low solution concentration is near the lower detection limit of the assay. The middle 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® Cortisol CalCheck is intended for use in periodic verification of the calibration of the Elecsys® Cortisol assay.

Source page: https://510kreport.com/device/K000576
Methodology: https://510kreport.com/methodology