# K984326: Elecys Ige Assay

- Pathway: 510(k) (Traditional)
- Applicant: Boehringer Mannheim Corp.
- Decided: Feb 8, 1999 after 67 days
- Product code: JHR (Radioimmunoassay, Immunoglobulins (D, E))
- 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; 1 cites 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. The FDA summary names its predicate without a number.
- (no number) Boehringer Mannheim Enzymun-Test IgE: named in the summary without a submission number

## Most influential descendants
- K061970: Elecsys Ige II Immunoassay (2006), 1 descendant of its own
- K220178: Total Immunoglobulin E (IgE) (2022), 0 descendants of its own

## Indications for use
For in vitro quantitative determination of immunoglobulin E in human serum and plasma. The electrochemiluminescence immunoassay “ECLIA” is intended for use on the Bocehringer Mannheim Elecsys 1010 and 2010 immunoassay analyzers. Determination of total serum IgE is useful as an aid in the disgnosis of allergic disease.

Source page: https://510kreport.com/device/K984326
Methodology: https://510kreport.com/methodology