# K964152: Unicap Total Ige Assay/Pharmacia Total Ige Controls LMH

- Pathway: 510(k) (Traditional)
- Applicant: Pharmacia, Inc.
- Decided: Apr 23, 1997 after 189 days
- Product code: DGC (Ige, Antigen, Antiserum, Control)
- Device class: 2
- Regulation: 21 CFR 866.5510
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
6 later devices descend from it; 3 cite it directly.
0 of 7 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 IgE FEIA: named in the summary without a submission number

## Most influential descendants
- K133404: Immunocap Total Ige: Conjugate, Anti-Ige, Calibrators, Curve Controls, Control LMH (2014), 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
- K050493: Quantia Ige (2005), 1 descendant of its own
- K231151: Kenota 1 Total IgE; Kenota 1 (instrument) (2024), 0 descendants of its own
- K214068: Quantia IgE (2023), 0 descendants of its own

## Indications for use
UniCAP Total IgE Flurorimmunoassay is an in vitro assay for the quantitative measurement of circulating total IgE in human serum or plasma. UniCAP Total 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 clinical findings, and is to be used in clinical laboratories, as well as, physician office laboratories. Pharmacia Total IgE Control LMH is intended for laboratory use in monitoring the performance of total IgE measurements as determined by Phadebas IgE PRIST /Phadezym IgE PRIST, Pharmacia IgE RIA, Pharmacia IgE RIACT, Pharmacia CAP System IgE RIA/FEIA and UniCAP Total IgE.

Source page: https://510kreport.com/device/K964152
Methodology: https://510kreport.com/methodology