# K061970: Elecsys Ige II Immunoassay

- Pathway: 510(k) (Special)
- Applicant: Roche Diagnostics
- Decided: Aug 31, 2006 after 50 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
Longest line of descent: 1 generation back to K961481 (1996). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K984326: Elecys Ige Assay, Boehringer Mannheim Corp. (1999) Summary page 1.
- K961481: Elecsys 2010 Analyzer, Boehringer Mannheim Corp. (1996) Summary page 1.

## Most influential descendants
- K220178: Total Immunoglobulin E (IgE) (2022), 0 descendants of its own

## Indications for use
Immunoassay for the in vitro quantitative determination of immunoglobulin E in human serum and plasma. Determination of total IgE is useful as an aid in the diagnosis of allergic diseases. The electrochemiluminescence immunoassay "ECLIA" is intended for use on the Roche Elecsys 2010 and MODULAR ANALYTICS E170 (Elecsys module) immunoassay analyzers.

Source page: https://510kreport.com/device/K061970
Methodology: https://510kreport.com/methodology