# K101572: Immulite 2000 3GALLERGY Specific Ige Assay Kit

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Healthcare Diagnostics
- Decided: Aug 1, 2011 after 423 days
- Product code: DHB (System, Test, Radioallergosorbent (Rast) Immunological)
- Device class: 2
- Regulation: 21 CFR 866.5750
- Recalls of this device: 4 (0 Class I)
- 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.
2 later devices descend from it; 1 cites it directly.
0 of 8 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.

## Most influential descendants
- 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-0492-2026: 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 
- Nov 4, 2022 · Class II · Z-0718-2023: Potential for falsely elevated specific IgE mold allergen reactivity with quality control material and patient samples, may result in false reactive result
- Nov 4, 2022 · Class II · Z-0716-2023: Potential for falsely elevated specific IgE mold allergen reactivity with quality control material and patient samples, may result in false reactive result
- Nov 4, 2022 · Class II · Z-0717-2023: Potential for falsely elevated specific IgE mold allergen reactivity with quality control material and patient samples, may result in false reactive result

## 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. The test results are to be used in conjunction with clinical findings and other laboratory tests.

Source page: https://510kreport.com/device/K101572
Methodology: https://510kreport.com/methodology