# K962976: Pharmacia Cap System Rast Feia

- Pathway: 510(k) (Traditional)
- Applicant: Pharmacia & Upjohn Co.
- Decided: Dec 23, 1996 after 145 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 K953014 (1995). 1 ancestor in all.
4 later devices descend from it; 1 cites 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)
- K953014: Alastat Microplate Latex-Specific Ige Allergen, Diagnostic Products Corp. (1995) Summary page 1.

## Most influential descendants
- K972068: Unicap Specific Ige Feia Assay, Latex Allergen Immunocap K82 (1997), 3 descendants of its own
- 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
Pharmacia CAP System RAST FEIA is an in vitro test which measures the concentration of circulating allergen specific IgE in human blood samples.

Source page: https://510kreport.com/device/K962976
Methodology: https://510kreport.com/methodology