# K962274: Unicap 100

- Pathway: 510(k) (Traditional)
- Applicant: Pharmacia, Inc.
- Decided: Sep 12, 1996 after 91 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.
37 later devices descend from it; 17 cite it directly.
0 of 38 devices 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 RAST FEIA: named in the summary without a submission number
- (no number) Positioning Guide 96: named in the summary without a submission number
- (no number) AutoCAP: named in the summary without a submission number
- (no number) FluoroCount 96: named in the summary without a submission number
- (no number) MasterCAP: named in the summary without a submission number
- (no number) Pharmacia Specific IgE Control: named in the summary without a submission number
- (no number) Phadexact Negative Control: named in the summary without a submission number

## Most influential descendants
- K051218: Modification to:  Unicap Specific Ige (2005), 30 descendants of its own
- K991048: Allergen Immunocap, Models E7, F93, F94, F95, F203, F204, F208, F209, F210, F214, F216, F235, F237, F242, F255, F259, F2 (1999), 2 descendants of its own
- K161899: ImmunoCAP Total IgE Calibrator Strip/Total IgE Curve Control Strip, ImmunoCAP Total IgE Calibrators/Total IgE Curve Controls, ImmunoCAP Specific IgE Calibrator Strip/Specific IgE Curve Control Strip, ImmunoCAP Specific IgE Calibrators/Specific IgE Curve Controls (2016), 1 descendant of its own
- K113841: Immunocap Allergen Components Bundle (2012), 1 descendant of its own
- K101251: Immunocap Allergen D202, Allergen Component Nder P 1, House Dust Mite, Immunocap Allergen D203, Allergen (2011), 1 descendant 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 100 is a fully integrated and automated instrument including software for immunodiagnostic testing. UniCAP 100 is a user friendly instrument designed to handle all steps from sample and reagent handling to processing of results. UniCAP 100 RM External Software is intended to be used with a Windows-based PC operating up to five UniCAP 100 instruments. The external software creates requests and assay runs, retrieves the test results from the instrument, and prints reports. It can also import requests from, and export requests to, a connected mainframe computer or network server. Pharmacia Specific IgE Control is intended for laboratory use in monitoring the performance of specific IgE measurements as determined by UniCAP™ Specific IgE and Pharmacia CAP System™ RAST® RIA/FEIA. Pharmacia Specific IgE Negative Control is intended for laboratory use in monitoring the performance of specific IgE measurements as determined by UniCAP™ Specific IgE, Pharmacia CAP System™, RAST® RIA/FEIA and Phadebas RAST® RIA/FEIA and Phadebas RAST®/Phadezym®.

Source page: https://510kreport.com/device/K962274
Methodology: https://510kreport.com/methodology