# K103548: Advia Centaur Calibarator 80 Model 10492491

- Pathway: 510(k) (Abbreviated)
- Applicant: Siemens Healthcare Diagnostics, Inc.
- Decided: Jun 2, 2011 after 181 days
- Product code: JIT (Calibrator, Secondary)
- Device class: 2
- Regulation: 21 CFR 862.1150
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K920372 (1992). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K920372: Acs Total Ige Immunoassay, Ciba Corning Diagnostics Corp. (1992) Summary page 1.

## Indications for use
For in vitro diagnostic use in calibrating the ADVIA Centaur® Total IgE (tIgE) quantitative assay on the ADVIA Centaur system.

Source page: https://510kreport.com/device/K103548
Methodology: https://510kreport.com/methodology