# K092978: Immunocap Rapid Reader, Model 12-3600-10

- Pathway: 510(k) (Traditional)
- Applicant: Phadia US, Inc.
- Decided: Jan 19, 2010 after 113 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.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K081830: Immunocap Rapid Inhalant Profile , Immunocap Rapid Reader, Immunocap Rapid Reader Check Device, and Immunocap Rapid QC1, Phadia AB (2009) Summary page 1.

## Indications for use
ImmunoCAP Rapid Reader, part of ImmunoCAP Rapid System, is an instrument including software to be used for reading and scoring ImmunoCAP Rapid assay results. It is intended for in vitro diagnostic use and is to be used in clinical laboratories, licensed under CLIA to perform non-waived assays.

Source page: https://510kreport.com/device/K092978
Methodology: https://510kreport.com/methodology