# K143376: ADIVA Centaur Progesterone Master Curve Material (MCM), ADIVA Centaur Ferritin Master Curve Material

- Pathway: 510(k) (Abbreviated)
- Applicant: Siemens Healthcare Diagnostics, Inc.
- Decided: Dec 23, 2014 after 28 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: 5 generations back to K950469 (1995). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K103683: Immulite/Immulite 1000 Progesterone Calibration Verification (CVM), Siemens Healthcare Diagnostics (2011) Summary page 5.
- K102267: Elecsys Ferritin Calcheck 5, Roche Diagnostics (2010) Summary page 11.

## Indications for use
The ADVIA Centaur® Progesterone (PRGE) Master Curve Material is for in vitro diagnostic use in the verification of calibration and reportable range of the ADVIA Centaur Progesterone assay. The ADVIA Centaur® Ferritin (FER) Master Curve Material is for in vitro diagnostic use in the verification of calibration and reportable range of the ADVIA Centaur Ferritin assay.

Source page: https://510kreport.com/device/K143376
Methodology: https://510kreport.com/methodology