# K101251: Immunocap Allergen D202, Allergen Component Nder P 1, House Dust Mite, Immunocap Allergen D203, Allergen

- Pathway: 510(k) (Traditional)
- Applicant: Phadia AB
- Decided: May 27, 2011 after 388 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: 2 generations back to K962274 (1996). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K051218: Modification to:  Unicap Specific Ige, Pharmacia Diagnostics AB (2005) Summary page 2.
- K962274: Unicap 100, Pharmacia, Inc. (1996) Summary page 2.

## Most influential descendants
- K150597: ImmunoCAP Allergen d202, Allergen component rDer p 1,House dust mite (2016), 0 descendants of its own

## Indications for use
ImmunoCAP Specific IgE is an in vitro quantitative assay for the measurement of allergen specific IgE in human serum or plasma. ImmunoCAP Specific IgE is to be used with instruments Phadia 100, Phadia 250, and Phadia 1000. It is intended for in vitro diagnostic use as an aid in the clinical diagnosis of IgE mediated allergic disorders in conjunction with other clinical findings, and is to be used in clinical laboratories.

Source page: https://510kreport.com/device/K101251
Methodology: https://510kreport.com/methodology