# K021206: Immulite 2000 Specific Allergens

- Pathway: 510(k) (Traditional)
- Applicant: Diagnostic Products Corp.
- Decided: May 30, 2002 after 44 days
- Product code: DHB (System, Test, Radioallergosorbent (Rast) Immunological)
- Device class: 2
- Regulation: 21 CFR 866.5750
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
10 later devices descend from it; 8 cite it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K101572: Immulite 2000 3GALLERGY Specific Ige Assay Kit (2011), 2 descendants of its own
- K100910: Immulite 2000 3GALLERGY Specific Ige Assay Kit, Model L2KUN6 (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
- K132801: Immulite 2000 Systems 3GALLERGY Specific Ige Assay (2014), 0 descendants of its own

## Recalls of this device
- Oct 6, 2025 · Class II · Z-0491-2026: The barcode orientation on affected devices causes incorrect scanning order of tubes within the allergen holder wedge. When using an IMMULITE 2000 / IMMULITE 2000 XPi instrument in combination with a 

## Indications for use
The IMMULITE® 2000 Allergen-Specific IgE and specific allergens are 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/K021206
Methodology: https://510kreport.com/methodology