Ig_Plex Celiac DGP Panel

FDA 510(k) K140691 · Sqi Diagnostics Systems, Inc.

Substantially Equivalent

510(k) numberK140691

Submission

Device name
Ig_Plex Celiac DGP Panel
Applicant
Sqi Diagnostics Systems, Inc.
Toronto, On, CA
Received
March 19, 2014
Decision date
November 6, 2014
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
MVM – Autoantibodies, Endomysial(Tissue Transglutaminase)
Device class
Class II (moderate risk)
Regulation
21 CFR 866.5660
Specialty
Immunology

Other 510(k)s with product code MVM

510(k)DeviceApplicantDecision
K200230Aptiva Celiac Disease IgG ReagentMVM · Traditional Inova Diagnostics, Inc.08/26/2021SE
K193604Aptiva Celiac Disease IgA ReagentMVM · Traditional Inova Diagnostics, Inc.06/16/2021SE
K181871EliA Celikey IgG Immunoassay; EliA GliadinDP IgA Immunoassay; EliA GliadinDP IgG…MVM · Traditional Phadia AB03/01/2019SE
K183313EUROIMMUN Anti-tissue Transglutaminase ELISA (IgA), EUROIMMUN Anti-tissue…MVM · Traditional Euroimmun Us, Inc.02/28/2019SE
K123713Immulisa Enhanced Celiac Fusion (Ttg/Dgp) Iga/Igg Antibody ElisaMVM · Traditional Immco Diagnostics, Inc.10/25/2013SE
K130053Bioplex 2200 Celiac Iga and Igg Kits on the Bioplex 2200 System, Bioplex 2200 Celiac Iga…MVM · Traditional Bio-Rad Laboratories, Inc.09/19/2013SE
K102490Igx Plex Celiac Qualitative AssayMVM · Traditional Sqi Diagnostics Systems06/02/2011SE
K101644Quanta Flash H-Ttg IggMVM · Traditional Inova Diagnostics, Inc.03/23/2011SE
K102964Eu-Ttg Iga and Eu-Ttg IggMVM · Traditional Grifols USA, Inc.03/07/2011SE
K094060Quanta Flash H-Ttg IgaMVM · Traditional Inova Diagnostics, Inc.10/13/2010SE

More from Inova Diagnostics, Inc.

510(k)DeviceDecision
K102490Igx Plex Celiac Qualitative AssayMVM · Traditional 06/02/2011SE
K083080Igx Plex Rheumatoid Arthritis (Ra) Assay and Sqidworks Diagnostics PlatformDHR · Traditional 10/29/2009SE

Questions and answers

When was Ig_Plex Celiac DGP Panel cleared by the FDA?

Ig_Plex Celiac DGP Panel (K140691) received a 510(k) decision of Substantially Equivalent on November 6, 2014, 232 days after the submission was received.

What is the product code of K140691?

The FDA product code is MVM – Autoantibodies, Endomysial(Tissue Transglutaminase), a Class II (moderate risk) device regulated under 21 CFR 866.5660.