# K920372: Acs Total Ige Immunoassay

- Pathway: 510(k) (Traditional)
- Applicant: Ciba Corning Diagnostics Corp.
- Decided: Apr 8, 1992 after 71 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
No predicates in its family tree.
2 later devices descend from it; 2 cite it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K193493: ADVIA Centaur Total IgE (tIgE) (2020), 0 descendants of its own
- K103548: Advia Centaur Calibarator 80 Model 10492491 (2011), 0 descendants of its own

Source page: https://510kreport.com/device/K920372
Methodology: https://510kreport.com/methodology