# K193493: ADVIA Centaur Total IgE (tIgE)

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Healthcare Diagnostics, Inc.
- Decided: Jan 15, 2020 after 29 days
- Product code: DGC (Ige, Antigen, Antiserum, Control)
- Device class: 2
- Regulation: 21 CFR 866.5510
- 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 4.

## Indications for use
For in vitro diagnostic use in the quantitative determination of total IgE in serum and plasma (EDTA and lithium heparin) using the ADVIA Centaur®, ADVIA Centaur XP, and ADVIA Centaur XPT systems.

Source page: https://510kreport.com/device/K193493
Methodology: https://510kreport.com/methodology