# K150854: ImmunoCAP Specific IgE; ImmunoCAP Allergen f439, Hazelnut; ImmunoCAP Allergen f440, Hazelnut; ImmunoCAP Allergen f441, Walnut; ImmunoCAP Allergen f442, Walnut; ImmunoCAP Allergen f443, Cashew nut

- Pathway: 510(k) (Traditional)
- Applicant: Phadia AB
- Decided: Dec 14, 2015 after 258 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 K894190 (1990). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 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 5.
- K962274: Unicap 100, Pharmacia, Inc. (1996) Summary page 5.
- K974580: Allergen Immunocap F256,F245,F207,F202, Pharmacia & Upjohn Co. (1998) Summary page 5.

## Indications for use
ImmunoCAP Specific IgE is an in vitro quantitative assay for the measurement of allergen specific IgE in human serum or plasma (EDTA or Na-Heparin). ImmunoCAP Specific IgE is to be used with instruments Phadia 100, Phadia 250, Phadia 1000, Phadia 2500 and Phadia 5000. 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/K150854
Methodology: https://510kreport.com/methodology