# K013134: Immulite 2000 Allergen-Specific Ige and Specific Allergens, Mdoel L2KUN6 (600 Tests)

- Pathway: 510(k) (Special)
- Applicant: Diagnostic Products Corp.
- Decided: Oct 15, 2001 after 26 days
- Product code: DHB (System, Test, Radioallergosorbent (Rast) Immunological)
- Device class: 2
- Regulation: 21 CFR 866.5750
- Recalls of this device: 2 (0 Class I)
- 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.
10 later devices descend from it; 8 cite it directly.
0 of 12 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
- K093987: Immulite 2000 3G Allergy Specific Ige Assay Kit Model L2KUN6 (2011), 2 descendants of its own
- K112523: Immulite 2000 3GALLERGY Specific Ige Assay Kit (2012), 1 descendant of its own
- K260331: IMMULITE 2000 3gAllergy Specific IgE Vantage; IMMULITE 2000 Systems Peanut Allergen (F13) (2026), 0 descendants of its own
- K132801: Immulite 2000 Systems 3GALLERGY Specific Ige Assay (2014), 0 descendants of its own

## Recalls of this device
- Jan 2, 2018 · Class II · Z-1674-2018: Concentrations for the level of biotin that does not interfere is not currently listed in the instruction for use for the Dimension Vista CTNI, Dimension Vista MMB, Dimension Sirolimus, ADVIA Centaur 
- May 6, 2015 · Class II · Z-1843-2015: IMMULITE 2000/2000XPi Italian Cypress (T23L4), Lots 206 and 208, fail to meet specifications to support the shelf-life stability of 2 years (24 months) expiration date as indicated on the products lab

## 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/K013134
Methodology: https://510kreport.com/methodology