# K140267: Advia Centaur Tni-Ultra Master Curve Material (MCM), Advia Centaur Digoxin Master Curve Material (MCM)

- Pathway: 510(k) (Abbreviated)
- Applicant: Siemens Healthcare Diagnostics, Inc.
- Decided: Mar 10, 2014 after 35 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: 4 generations back to K924862 (1992). 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)
- K100594: Elecsys Troponin I Calcheck 5, Roche Diagnostics (2010) Summary page 1.
- K102044: Elecsys Digoxin Calcheck 5, Roche Diagnostics (2010) Summary page 7.

## Indications for use
The ADVIA Centaur® TnI-Ultra Master Curve Material is for in vitro diagnostic use in the verification of calibration and reportable range of the ADVIA Centaur TnI-Ultra assay. The ADVIA Centaur® Digoxin Master Curve Material is for in vitro diagnostic use in the verification of calibration and reportable range of the ADVIA Centaur Digoxin assay.

Source page: https://510kreport.com/device/K140267
Methodology: https://510kreport.com/methodology