# K220178: Total Immunoglobulin E (IgE)

- Pathway: 510(k) (Traditional)
- Applicant: Beckman Coulter, Inc.
- Decided: Mar 23, 2022 after 61 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: 2 generations back to K961481 (1996). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K061970: Elecsys Ige II Immunoassay, Roche Diagnostics (2006) Summary page 4.

## Indications for use
The IgE assay is intended for use in the quantitative determination of Total Immunoglobulin E (IgE) concentration in human serum and plasma (lithium heparin, sodium heparin, K2-EDTA, K3-EDTA) on Beckman Coulter AU/DxC AU clinical chemistry analyzers. The determination aids in the diagnosis of IgE-mediated allergic disorders in conjunction with other clinical findings. For in vitro diagnostic use only.

Source page: https://510kreport.com/device/K220178
Methodology: https://510kreport.com/methodology