# K020387: Myallergytest System

- Pathway: 510(k) (Traditional)
- Applicant: Immunetech Corporation
- Decided: Apr 17, 2002 after 71 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.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Pharmacia CAP System™ Specific IgE FEIA: named in the summary without a submission number

## Most influential descendants
- K032251: Immunetech Total Ige System (2003), 0 descendants of its own

## Indications for use
The MyAllergyTest System is a quantitative in vitro diagnostic test for the measurement of allergen specific IgE antibodies in human serum samples. The MyAllergyTest System may only be run on the Luminex ™ Integrated System Version 2.0. The MyAllergyTest™ System is used as an aid in the clinical diagnosis of IgE mediated allergenic disorders. Measurement of allergen specific IgE antibodies may aid diagnosis of asthma, allergies, and other pulmonary disorders.

Source page: https://510kreport.com/device/K020387
Methodology: https://510kreport.com/methodology