# K193613: Allergen-Specific IgE Assay 12 Allergen Bundle

- Pathway: 510(k) (Traditional)
- Applicant: Hitachi Chemical Diagnostics, Inc.
- Decided: Oct 18, 2021 after 662 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device 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.

## Indications for use
The OPTIGEN® Allergen-Specific IgE Assay 12 Allergen Bundle A is an in vitro test for use in the semi-quantitative determination of circulating allergen specific IgE concentrations in human serum. OPTIGEN® Allergen-Specific IgE assays are meant to be included in panel tests to be used with the AP3600™ instrument. Each assay is intended for in vitro diagnostic use as an aid in the clinical diagnosis of IgE mediated allergenic disorders in conjunction with other clinical findings and are to be used in clinical laboratories. The OPTIGEN® 12 Allergen Bundle A includes Almond (f20), Bermuda Grass (g2), Cashew (£202), Clam (f207), Crab (f23), Hazelnut (Food) (f17), Oak, White (t7), Salmon (f41), Sesame Seed (f10), Shrimp (f24), Tuna (f40), and Walnut (Food) (£256).

Source page: https://510kreport.com/device/K193613
Methodology: https://510kreport.com/methodology