# K132801: Immulite 2000 Systems 3GALLERGY Specific Ige Assay

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Healthcare Diagnostics, Inc.
- Decided: May 28, 2014 after 257 days
- Product code: DHB (System, Test, Radioallergosorbent (Rast) Immunological)
- Device class: 2
- Regulation: 21 CFR 866.5750
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K911511 (1991). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K112523: Immulite 2000 3GALLERGY Specific Ige Assay Kit, Siemens Healthcare Diagnostics, Inc. (2012) Summary page 1.

## Indications for use
The 3gAllergy Specific IgE Universal Kit is for in vitro diagnostic use with the IMMULITE 2000 Analyzer - for the quantitative measurement of allergen-specific IgE in human serum, as an aid in the clinical diagnosis of IgE-mediated allergic disorders. The test results are to be used in conjunction with clinical findings and other laboratory tests.

Source page: https://510kreport.com/device/K132801
Methodology: https://510kreport.com/methodology