# K182793: AP3600 Automated Instrument

- Pathway: 510(k) (Traditional)
- Applicant: Hitachi Chemical Diagnostics, Inc.
- Decided: Mar 19, 2019 after 169 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 AP 3600 Automated Instrument, in conjunction with the OPTIGEN Allergen-Specific IgE Assay, is for the semi-quantitative measurement of circulating allergen-specific IgE antibodies in human serum. The OPTIGEN Allergen-Specific IgE Assay is intended to aid in the clinical diagnosis of IgE mediated allergic disorders in conjunction with other clinical findings. The AP 3600 Automated Instrument is a software-enabled instrument designed for use with the OPTIGEN Allergen-Specific IgE Assay in clinical laboratories for sample processing, measurement analyses, and reporting of OPTIGEN Allergen-Specific IgE Assay results.

Source page: https://510kreport.com/device/K182793
Methodology: https://510kreport.com/methodology