# K030590: Cla Allergen-Specific Ige Assay-Latex Allergen (K82)

- Pathway: 510(k) (Special)
- Applicant: Hitachi Chemical Diagnostics, Inc.
- Decided: Mar 21, 2003 after 24 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: 3 generations back to K953014 (1995). 4 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K914850: Chemiluminescent System Allergan Specific Ige, Mast Immunosystems (1991) Summary page 2.
- K972068: Unicap Specific Ige Feia Assay, Latex Allergen Immunocap K82, Pharmacia, Inc. (1997) Summary page 2.

## Most influential descendants
- K051677: Optigen Allergen Specific Ige Assay (2006), 0 descendants of its own

## Indications for use
The CLA@Allergen-Specific IgE Assay is a single use in vitro test for the semi quantitative determination of circulating allergen-specific IgE concentrations in human serum.

Source page: https://510kreport.com/device/K030590
Methodology: https://510kreport.com/methodology