# K051677: Optigen Allergen Specific Ige Assay

- Pathway: 510(k) (Traditional)
- Applicant: Hitachi Chemical Diagnostics, Inc.
- Decided: Jan 23, 2006 after 216 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
Longest line of descent: 4 generations back to K953014 (1995). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K030590: Cla Allergen-Specific Ige Assay-Latex Allergen (K82), Hitachi Chemical Diagnostics, Inc. (2003) Summary page 2.
- K962274: Unicap 100, Pharmacia, Inc. (1996) Summary page 2.

## Recalls of this device
- Dec 21, 2012 · Class III · Z-0793-2013: There is no evidence that a visual inspection was performed on one tray of coverslips. Possibility of a low fill volume which could lead to a false negative results.

## Indications for use
The OPTIGEN assay is an in vitro test, which provides a semi quantitative measurement of circulating allergen specific IgE antibodies in human serum. The OPTIGEN assay is intended to assist in the clinical diagnosis of IgE-mediated allergic disorders. This device is designed for use in clinical laboratories.

Source page: https://510kreport.com/device/K051677
Methodology: https://510kreport.com/methodology