Identifiers
- 510(k) Number
- K982701 FDA 510(k)
- FDA Product Code
- MST FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 866.5750 FDA 510(k)
- Regulation Number
- 866.5750 FDA 510(k)
- Advisory Committee
- Immunology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The UniCAP Gliadin IgG Assay is an in vitro diagnostic device designed for the semi-quantitative measurement of IgG antibodies specific to gliadin in human serum. It falls under the category of antibody-based assays and is intended for use in immunology testing to aid in the diagnosis of gluten-related disorders, such as celiac disease.
This assay is supplied as a single-use diagnostic test and is intended for use in clinical laboratory settings. It requires compatibility with the UniCAP instrument for analysis and is regulated under FDA 510(k) clearance (K982701) as a Class II device under product code MST. The device is not sterile and must be handled according to standard laboratory protocols for in vitro diagnostics.
Frequently asked questions
What clinical conditions is the UniCAP Gliadin IgG Assay intended to help diagnose?
The UniCAP Gliadin IgG Assay is designed to aid in the diagnosis of gluten-related disorders, specifically celiac disease. It measures IgG antibodies specific to gliadin in human serum, helping clinicians identify potential gluten sensitivity or celiac disease in patients.
Is the UniCAP Gliadin IgG Assay single-use or reusable, and where should it be used?
The UniCAP Gliadin IgG Assay is a single-use diagnostic test, meaning each test kit is intended for one use only. It is specifically designed for use in clinical laboratory settings, where it requires compatibility with the UniCAP instrument for analysis.
How is the sterility of the UniCAP Gliadin IgG Assay handled, and what precautions should be taken?
The UniCAP Gliadin IgG Assay is not sterile, so it must be handled according to standard laboratory protocols for in vitro diagnostics. Users should follow general aseptic techniques and manufacturer guidelines to prevent contamination during testing.
What regulatory pathway was followed for the FDA clearance of this device, and what class does it belong to?
The UniCAP Gliadin IgG Assay received FDA clearance through a Traditional 510(k) pathway (K982701) and is classified as a Class II device under product code MST. The clearance was determined under the Immunology advisory committee (IM) and was deemed substantially equivalent to a predicate device.
Does this assay require a specific instrument for operation, and if so, what is it?
Yes, the UniCAP Gliadin IgG Assay requires compatibility with the UniCAP instrument for analysis. The test cannot be performed independently—it must be used with this specific system in a clinical laboratory setting.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: UNICAP GLIADIN IGG ASSAY (K982701) — FDA 510 (k) | Innolitics, K982701 FDA 510 (k) - UNICAP GLIADIN IGG ASSAY, UNICAP GLIADIN IGG ASSAY 510 (k) K982701 - FDA.report, fda.innolitics.com
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K982701 | Class II | Active |
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Manufacturer
- Manufacturer
- Pharmacia & Upjohn Co.
Sources (1)
- FDA 510(k) K982701 24 fields · synced Sep 19, 2026