# K982701: Unicap Gliadin Igg Assay

- Pathway: 510(k) (Traditional)
- Applicant: Pharmacia & Upjohn Co.
- Decided: Oct 22, 1998 after 94 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The summary cites one number, which could not be confirmed as its predicate (listed below).
- (no number) ImmuLisa™ IgG Anti-Gliadin Antibody: named in the summary without a submission number

## Cited in the summary but kept off the family tree
- K982533: Unicap Gliadin Iga Assay, Pharmacia & Upjohn Co. (1998). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Indications for use
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. UniCAP Gliadin IgA/IgG ImmunoCAP is intended to be used with the instrument UniCAP together with reagents as stated in the Directions for Use provided with UniCAP Specific IgA. It is intended for in vitro diagnostic use as an aid in the diagnosis of patients with celiac disease. 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 UniCAP Specific IgA is bound to the Antigen ImmunoCAP solid phase component of the UniCAP Specific IgA system. UniCAP Specific IgA assay is to be used with the instrument 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. 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. UniCAP Gliadin IgA/IgG ImmunoCAP is intended to be used with the instrument UniCAP together with reagents as stated in the Directions for Use provided with UniCAP Specific IgG. It is intended for in vitro diagnostic use as an aid in the diagnosis of patients with celiac disease. UniCAP Specific IgG is an in vitro test system for the quantitative measurement of antigen specific IgG antibodies. The corresponding antigen for the specific antibody to be measured by UniCAP Specific IgG is bound to the Antigen ImmunoCAP solid phase component of the UniCAP Specific IgG system. UniCAP Specific IgG assay is to be used with the instrument 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/K982701
Methodology: https://510kreport.com/methodology