# K993388: Allergen Immundocap MODELC5, C6, C73, E201, E213, F50, F51,F54, F55, F56, F57, F58, F59, F60, F61, F205, F213, F218, F

- Pathway: 510(k) (Traditional)
- Applicant: Pharmacia & Upjohn Co.
- Decided: Dec 1, 1999 after 54 days
- Product code: DHB (System, Test, Radioallergosorbent (Rast) Immunological)
- Device class: 2
- Regulation: 21 CFR 866.5750
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K894190 (1990). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K894190: Pharmacia Cap System Rast Ria & Rast Feia, Pharmacia, Inc. (1990) Summary page 2.
- K911903: Allergans Pharmacia Cap Sys.Rast Ria/Feia, Pharmacia, Inc. (1991) Summary page 2.
- K962274: Unicap 100, Pharmacia, Inc. (1996) Summary page 2.

## Recalls of this device
- Dec 18, 2017 · Class II · Z-1312-2018: The stability specifications of ImmunoCAP Allergen c5, Ampicilloyl were not met.
- Dec 18, 2017 · Class II · Z-1313-2018: The stability specifications of ImmunoCAP Allergen c6, Amoxicilloyl were not met.

## Indications for use
Allergen ImmunoCAP™ is the solid phase component of the Pharmacia & Upjohn in vitro immunodiagnostic systems which measure specific IgE to the respective allergen bound to the ImmunoCAP. Allergen ImmunoCAP are intended to be used with Pharmacia CAP System RAST FEIA and UniCAP Specific IgE in vitro diagnostic assays. Pharmacia CAP System RAST® FEIA and UniCAP® Specific IgE are intended for in vitro diagnostic use as an aid in the clinical diagnosis of IgE mediated allergic disorders in conjunction with other findings, and are to be used in clinical laboratories, as well as, physician office laboratories.

Source page: https://510kreport.com/device/K993388
Methodology: https://510kreport.com/methodology