# K972364: Unicap Phadiatop

- Pathway: 510(k) (Traditional)
- Applicant: Pharmacia, Inc.
- Decided: Sep 4, 1997 after 71 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Pharmacia CAP System Phadiatop FEIA: named in the summary without a submission number

## Indications for use
UniCAP Phadiatop Assay is an in vitro qualitative assay for the differential determination of IgE antibodies specific to inhalant allergens in human serum and plasma. UniCAP Phadiatop Assay is to be used with the instrument UniCAP 100. It is intended for in vitro diagnostic use as an aid in the clinical diagnosis of IgE mediated allergic disorders in conjunction with other findings, and is to be used in clinical laboratories, as well as, physician office laboratories.

Source page: https://510kreport.com/device/K972364
Methodology: https://510kreport.com/methodology