# K081217: HY-Tec Specific and Total Ige Eia System

- Pathway: 510(k) (Special)
- Applicant: Hycor Biomedical, Inc.
- Decided: May 22, 2008 after 22 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: 1 generation back to K941278 (1995). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K941278: HY-Tec Automated Eia System, Hycor Biomedical, Inc. (1995) Summary page 1.

## Recalls of this device
- Jul 25, 2018 · Class II · Z-0224-2020: Some of the Stop Solution bottles, a caustic solution, have been reported to leak.

## Indications for use
The HYoTECTM Specific and Total IgE EIA System is an enzyme immunoassay (EIA) method for the quantitative determination of allergen-specific and/or total IgE concentrations in human serum. The assay is to be used with the HYoTECTM 288 instrument for in-vitro diagnostic use. Measurement of specific allergen antibodies and total IgE may aid in the diagnosis of asthma, allergies and other pulmonary disorders.

Source page: https://510kreport.com/device/K081217
Methodology: https://510kreport.com/methodology