# K143680: ADVIA Centaur IgE Master Curve Material

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Healthcare Diagnostics, Inc.
- Decided: Jan 27, 2015 after 34 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: 2 generations back to K102269 (2010). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K133122: Immulite 2000; 3GALLERGY Specific Ige Control Verification Material (CVM), Total Ige Control Verification Material (CVM), Siemens Healthcare Diagnostics, Inc. (2013) Summary page 4.

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

Source page: https://510kreport.com/device/K143680
Methodology: https://510kreport.com/methodology