Cleared Traditional

BINDAZYME HUMAN ANTI-GLIADIN (MGP), IGG EIA KIT; BINDAZYME HUMAN ANTI-GLIADIN (MGP) IGA EIA KIT; (IGA OR IGG)

K081674 · The Binding Site, Ltd. · Immunology
Oct 2008
Decision
120d
Days
Class 2
Risk

About This 510(k) Submission

K081674 is an FDA 510(k) clearance for the BINDAZYME HUMAN ANTI-GLIADIN (MGP), IGG EIA KIT; BINDAZYME HUMAN ANTI-GLIADIN (MGP) IGA EIA KIT; (IGA OR IGG), a Antibodies, Gliadin (Class II — Special Controls, product code MST), submitted by The Binding Site, Ltd. (Santa Monica, US). The FDA issued a Cleared decision on October 15, 2008, 120 days after receiving the submission on June 17, 2008. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5750.

Submission Details

510(k) Number K081674 FDA.gov
FDA Decision Cleared SESE
Date Received June 17, 2008
Decision Date October 15, 2008
Days to Decision 120 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Statement

Device Classification

Product Code MST — Antibodies, Gliadin
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.5750

Similar Devices — MST Antibodies, Gliadin

All 41
ImmuLisa Enhanced Gliadin IgA Antibody ELISA, ImmuLisa Enhanced Gliadin IgG Antibody ELISA
K163177 · Immco Diagnostics, Inc. · Jul 2017
AESKULISA DGP-A, AESKULISA DGP-G,AESKULISA DGP-CHECK
K132082 · Aesku Diagnostics · Dec 2013
GLIADIN IGA AND GLIADIN LGA
K113377 · Grifols USA, LLC · Dec 2012
QUANTA FLASH DGP IGA, QUANTA FLASH DGP IGG, QUANTA FLASH DGP IGA CALIBRATORS, QUANTA FLASH DGP IGG CALIBRATORS
K113863 · Inova Diagnostics, Inc. · Sep 2012
QUANTA FLASH (TM) DGP SCREEN
K111414 · Inova Diagnostics, Inc. · Oct 2011
ELIA GLIADIN DP IGA IMMUNOASSAY AND ELIA GLIADIN DP IGG IMMUNOASSAY, MODELS 14-5538-01, 14-5539-01
K093459 · Phadia US, Inc. · Aug 2010