# K143194: ADIVA Centaur Prolactin Master Curve Material (MCM), ADIVA Centaur Cortisol Master Curve Material (MCM)

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Healthcare Diagnostics, Inc.
- Decided: Dec 5, 2014 after 29 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: 7 generations back to K001015 (2000). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K110613: Elecsys Prolactin II Calcheck 5, Roche Diagnostics (2011) Summary page 5.
- K000576: Elecsys Cortisol Calcheck, Roche Diagnostics Corp. (2000) Summary page 12.

## Indications for use
The ADVIA Centaur® Prolactin (PRL) Master Curve Material is for in vitro diagnostic use in the verification of calibration and reportable range of the ADVIA Centaur Prolactin assay. The ADVIA Centaur® Cortisol (COR) Master Curve Material is for in vitro diagnostic use in the verification of calibration and reportable range of the ADVIA Centaur Cortisol assay.

Source page: https://510kreport.com/device/K143194
Methodology: https://510kreport.com/methodology