# K021698: MY Allergy Test

- Pathway: 510(k) (Traditional)
- Applicant: Immunetech Corporation
- Decided: Sep 19, 2002 after 120 days
- Product code: JKA (Tubes, Vials, Systems, Serum Separators, Blood Collection)
- Device class: 2
- Regulation: 21 CFR 862.1675
- Recalls of this device: 6 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K861697 (1986). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K993787: Appraise-Cardio Sample Collection Kit, Osborn Group, Inc. (2000) Summary page 2.

## Recalls of this device
- Nov 4, 2011 · Not classified · Z-0286-2012: ImmuneTech is recalling certain Specimen Collection Kits that contain Triad brand non-sterile alcohol prep pads which have been recalled by Triad Group, Hartland, WI due to Bacillus cereus, microbial 
- Nov 4, 2011 · Not classified · Z-0287-2012: ImmuneTech is recalling certain Specimen Collection Kits that contain Triad brand non-sterile alcohol prep pads which have been recalled by Triad Group, Hartland, WI due to Bacillus cereus, microbial 
- Nov 4, 2011 · Not classified · Z-0288-2012: ImmuneTech is recalling certain Specimen Collection Kits that contain Triad brand non-sterile alcohol prep pads which have been recalled by Triad Group, Hartland, WI due to Bacillus cereus, microbial 
- Nov 4, 2011 · Not classified · Z-0290-2012: ImmuneTech is recalling certain Specimen Collection Kits that contain Triad brand non-sterile alcohol prep pads which have been recalled by Triad Group, Hartland, WI due to Bacillus cereus, microbial 
- Nov 4, 2011 · Not classified · Z-0291-2012: ImmuneTech is recalling certain Specimen Collection Kits that contain Triad brand non-sterile alcohol prep pads which have been recalled by Triad Group, Hartland, WI due to Bacillus cereus, microbial 
- Nov 4, 2011 · Not classified · Z-0289-2012: ImmuneTech is recalling certain Specimen Collection Kits that contain Triad brand non-sterile alcohol prep pads which have been recalled by Triad Group, Hartland, WI due to Bacillus cereus, microbial 

## Indications for use
The MyAllergyTestTM is for the collection and transport of a capillary blood sample to a clinical laboratory for allergen specific IgE profile testing. The MyAllergyTestTM is intended for use with the MyAllergyTestTM System. The MyAllergyTestTM is intended for home use by the lay consumer (Over-the-counter).

Source page: https://510kreport.com/device/K021698
Methodology: https://510kreport.com/methodology