# K972068: Unicap Specific Ige Feia Assay, Latex Allergen Immunocap K82

- Pathway: 510(k) (Traditional)
- Applicant: Pharmacia, Inc.
- Decided: Jul 3, 1997 after 30 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 K953014 (1995). 2 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K962976: Pharmacia Cap System Rast Feia, Pharmacia & Upjohn Co. (1996) Summary page 2.

## Most influential descendants
- K030590: Cla Allergen-Specific Ige Assay-Latex Allergen (K82) (2003), 1 descendant of its own
- K121463: Immunocap Allergen K82 (2013), 0 descendants of its own
- K051677: Optigen Allergen Specific Ige Assay (2006), 0 descendants of its own

## Indications for use
UniCAP Specific IgE Assay is an in vitro semi-quantitative assay for the measurement of allergen Specific IgE in human serum or plasma. UniCAP Specific IgE 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. UniCAP Specific IgE Assay, Latex k82 test result may be used as an aid in the clinical diagnosis of patients with suspected latex allergy.

Source page: https://510kreport.com/device/K972068
Methodology: https://510kreport.com/methodology