# K091289: Immulite 2000 3GALLERGY Specific Ige Assay Kit

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Healthcare Diagnostics
- Decided: Aug 6, 2009 after 97 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: 2 generations back to K911511 (1991). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K013134: Immulite 2000 Allergen-Specific Ige and Specific Allergens, Mdoel L2KUN6 (600 Tests), Diagnostic Products Corp. (2001) Summary page 2.
- K021206: Immulite 2000 Specific Allergens, Diagnostic Products Corp. (2002) Summary page 2.
- K013135: Immunlite 2000 Allergen-Specific Ige and Mixed Allergen Panels, Model L2KUN6 (600 Tests), Diagnostic Products Corp. (2001) Summary page 2.
- K021208: Immulite 2000 Mixed Allergen Panels, Diagnostic Products Corp. (2002) Summary page 2.

## Indications for use
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.

Source page: https://510kreport.com/device/K091289
Methodology: https://510kreport.com/methodology