# K260331: IMMULITE 2000 3gAllergy Specific IgE Vantage; IMMULITE 2000 Systems Peanut Allergen (F13)

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Healthcare Diagnostics Products, Ltd.
- Decided: Sep 4, 2026 after 214 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). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 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 6.

## Indications for use
The IMMULITE 2000 3gAllergy Specific IgE Vantage assay is for in vitro diagnostic use with the IMMULITE 2000 Systems Analyzers — 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/K260331
Methodology: https://510kreport.com/methodology