# K080322: HY*Tec Extended Specific Ige Eia, MCS Assay Using Tecan Freedom Evo RSP 200

- Pathway: 510(k) (Special)
- Applicant: Hycor Biomedical, Inc.
- Decided: Mar 5, 2008 after 28 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: 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.

## Indications for use
The HYoTECTM Extended Specific IgE EIA, MCS Assay Using The Tecan Freedom EVO® RSP 200 is an enzyme inmmunoassay (EIA) method for the quantitative determination of allergen-specific IgE concentrations in human serum. The assay system is for in-vitro diagnostic use. Measurement of specific allergen antibodies may aid in the diagnosis of asthma, allergies, and other pulmonary disorders.

Source page: https://510kreport.com/device/K080322
Methodology: https://510kreport.com/methodology