# K013135: Immunlite 2000 Allergen-Specific Ige and Mixed Allergen Panels, Model L2KUN6 (600 Tests)

- Pathway: 510(k) (Special)
- Applicant: Diagnostic Products Corp.
- Decided: Oct 19, 2001 after 30 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: 1 generation back to K911511 (1991). 1 ancestor in all.
8 later devices descend from it; 6 cite it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K911511: Alastat Allergen Specified Ige System, Modified, Diagnostic Products Corp. (1991) Summary page 1.

## Most influential descendants
- K101572: Immulite 2000 3GALLERGY Specific Ige Assay Kit (2011), 2 descendants of its own
- K112523: Immulite 2000 3GALLERGY Specific Ige Assay Kit (2012), 1 descendant of its own
- K132801: Immulite 2000 Systems 3GALLERGY Specific Ige Assay (2014), 0 descendants of its own
- K091984: Immulite 2000 3GALLERGY Specific Ige Assay Kit, Model L2KUN6 (2009), 0 descendants of its own
- K091289: Immulite 2000 3GALLERGY Specific Ige Assay Kit (2009), 0 descendants of its own

## Indications for use
The IMMULITE® 2000 Allergen-Specific IgE is for in vitro diagnostic use with the IMMULITE® 2000 Analyzer — for the 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/K013135
Methodology: https://510kreport.com/methodology