# K140505: Advia Centaur Vitamin B12 Master Curve Material, Total HCG Master Curve Material, and Testosterone Master Curve Material

- Pathway: 510(k) (Abbreviated)
- Applicant: Siemens Healthcare Diagnostics, Inc.
- Decided: Mar 31, 2014 after 32 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). 11 ancestors in all.
3 later devices descend from it; 1 cites it directly.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K060755: Elecsys Vitamin B12 Immunoassay, Calset II and Calcheck, Roche Diagnostics Corp. (2006) Summary page 1.
- K092168: Elecsys HCG+B Calcheck 5, Roche Diagnostics (2009) Summary page 7.
- K970146: Elecsys Calcheck Testosterone, Boehringer Mannheim Corp. (1997) Summary page 13.

## Most influential descendants
- K151986: ADVA Centaur Testosterone II (TSTII), ADVA Centaur Testosterone II (TSTII) Master Curve Material, ADVIA Centaur SHBG, ADVIA Centaur SHBG Calibrator, ADVIA Centaur SHBG Master Curve Material (2016), 2 descendants of its own
- K191533: ADVIA Centaur Testosterone II (TSTII), ADVIA Centaur SHBG (2019), 0 descendants of its own
- K190121: Ids SHBG (2019), 0 descendants of its own

## Indications for use
The ADVIA Centaur Vitamin B12 (VB12) Master Curve Material is for in vitro diagnostic use in the verification of calibration and reportable range of the ADVIA Centaur VB12 assay. The ADVIA Centaur Total hCG (ThCG) Master Curve Material is for in vitro diagnostic use in the verification of calibration and reportable range of the ADVIA Centaur ThCG assay. The ADVIA Centaur Testosterone (TSTO) Master Curve Material is for in vitro diagnostic use in the verification of calibration and reportable range of the ADVIA Centaur Testosterone assay.

Source page: https://510kreport.com/device/K140505
Methodology: https://510kreport.com/methodology