# K052793: Immunocap/Unicap Gliadin Iga, Immunocap/Unicap Specific Iga, Models 14-4425-40, 10-9306-02

- Pathway: 510(k) (Traditional)
- Applicant: Pharmacia Diagnostics AB
- Decided: Feb 7, 2006 after 127 days
- Product code: MST (Antibodies, Gliadin)
- 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 K982533 (1998). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K982533: Unicap Gliadin Iga Assay, Pharmacia & Upjohn Co. (1998) Summary page 1.

## Indications for use
ImmunoCAP/UniCAP Gliadin IgA/IgG ImmunoCAP® is a device for the in vitro semi-quantitative measurement of IgA or IgG antibodies specific for gliadin in human serum. ImmunoCAP/UniCAP Gliadin IgA/IgG ImmunoCAP is intended to be used with the instrument immunoCAP/UniCAP together with reagents as stated in the Directions for Use provided with ImmunoCAP/UniCAP Specific IgA and ImmunoCAP/UniCAP Specific IgG. It is intended for in vitro diagnostic use as an aid in the diagnosis of patients with celiac disease. ImmunoCAP/UniCAP Specific IgA is an in vitro test system for the quantitative measurement of antigen specific IgA antibodies. The corresponding antigen for the specific antibody to be measured by ImmunoCAP/UniCAP Specific IgA is bound to the Antigen ImmunoCAP solid phase component of the ImmunoCAP/UniCAP Specific IgA system. ImmunoCAP/UniCAP Specific IgA assay is to be used with the instrument ImmunoCAP/UniCAP. It is intended for in vitro diagnostic use in conjunction with other clinical findings, and is to be used in clinical laboratories, as well as physician office laboratories.

Source page: https://510kreport.com/device/K052793
Methodology: https://510kreport.com/methodology