# K071913: Immunocap Allergen F338, Scallop with Model (S): 14-4895-01

- Pathway: 510(k) (Traditional)
- Applicant: Phadia AB
- Decided: Aug 24, 2007 after 44 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)
- K051218: Modification to:  Unicap Specific Ige, Pharmacia Diagnostics AB (2005)

## Indications for use
ImmunoCAP Specific IgE is an in vitro quantitative assay for the measurement of allergen specific IgE in human serum or 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, as well as physician office laboratories. ImmunoCAP Allergen 338, Scallop is to be used with the ImmunoCAP Instrument System, ImmunoCAP 100, ImmunoCAP 250, and ImmunoCAP 1000.

Source page: https://510kreport.com/device/K071913
Methodology: https://510kreport.com/methodology