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Ig_plex Celiac Dgp Panel

by Sqi Diagnostics Systems, Inc.

510(k) K140691

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 6 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK140691 Date6 Nov 2014ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 6 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
MVM
Device Class
Class II
Regulation
21 CFR Part 866.5660
Advisory Committee
Immunology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 26 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Igplex Celiac DGP Panel is a multiplexed immunoassay used on the sqid-X system to detect celiac disease-related autoantibodies. It is an in vitro diagnostic test for the semi-quantitative detection of IgA and IgG immunoglobulin classes of antibodies to deamidated gliadin peptide (DGP) and tissue transglutaminase (tTG) in human serum. The device utilizes a 96-well microarray plate containing capture spots for DGP, tTG, and internal controls.

The Igplex Celiac DGP Panel is manufactured by SQI Diagnostics Systems, Inc. and is supplied as a single-use device. It is regulated under FDA 510(k) with product code MVM and regulation number 866.5660, classified as Autoantibodies, Endomysial (tissue Transglutaminase) with medical specialty in Immunology. The device received FDA clearance on November 6, 2014, with K number K140691.

Other devices from Sqi Diagnostics Systems, Inc.

Questions

AI-generated answers, 26 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the Igplex Celiac DGP Panel used for?

    The Igplex Celiac DGP Panel is an in vitro diagnostic test used to detect celiac disease-related autoantibodies. It semi-quantitatively measures IgA and IgG immunoglobulin classes of antibodies to deamidated gliadin peptide (DGP) and tissue transglutaminase (tTG) in human serum.

  • How is the Igplex Celiac DGP Panel supplied?

    The Igplex Celiac DGP Panel is supplied as a single-use device. It includes a 96-well microarray plate containing capture spots for DGP, tTG, and internal controls, designed to be used with the sqid-X system.

  • Is the Igplex Celiac DGP Panel reusable or single-use?

    The Igplex Celiac DGP Panel is a single-use device and should not be reused. Each microarray plate is designed for one testing procedure to ensure accurate and reliable results.

  • What is the regulatory status of the Igplex Celiac DGP Panel?

    The Igplex Celiac DGP Panel is regulated under FDA 510(k) with product code MVM and regulation number 866.5660. It received FDA clearance on November 6, 2014, with K number K140691, and is classified as Autoantibodies, Endomysial (tissue Transglutaminase) with medical specialty in Immunology.