# K081830: Immunocap Rapid Inhalant Profile , Immunocap Rapid Reader, Immunocap Rapid Reader Check Device, and Immunocap Rapid QC1

- Pathway: 510(k) (Traditional)
- Applicant: Phadia AB
- Decided: Mar 16, 2009 after 259 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 K962274 (1996). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K962274: Unicap 100, Pharmacia, Inc. (1996) Summary page 1.

## Most influential descendants
- K092978: Immunocap Rapid Reader, Model 12-3600-10 (2010), 0 descendants of its own

## Indications for use
ImmunoCAP Rapid Inhalant Profile 1, part of the ImmunoCAP Rapid System, is an in vitro semiquantitative assay for measurement of allergen specific IgE to ten inhalant allergens (house dust mite, cat, dog, mold, and pollen from common ragweed, Bermuda grass, timothy grass, oak, and elm) in heparinized human capillary whole blood, heparinized venous whole blood, or heparinized plasma. 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, licensed under CLIA to perform nonwaived assays.

Source page: https://510kreport.com/device/K081830
Methodology: https://510kreport.com/methodology