Cleared Traditional

K113377 - GLIADIN IGA AND GLIADIN LGA

K113377 is an FDA 510(k) clearance for GLIADIN IGA AND GLIADIN LGA, manufactured by Grifols USA, LLC. The device is a Class 2 Immunology device with product code MST cleared through the Traditional 510(k) pathway after a 394-day FDA review.

K113377 · Grifols USA, LLC · Immunology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2012
Decision
394d
Days
Class 2
Risk

K113377 is an FDA 510(k) clearance for the GLIADIN IGA AND GLIADIN LGA. Classified as Antibodies, Gliadin (product code MST), Class II - Special Controls.

Submitted by Grifols USA, LLC (Los Angeles, US). The FDA issued a Cleared decision on December 14, 2012 after a review of 394 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.5750 - the FDA immunology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Immunology review framework, consistent with the majority of Class II 510(k) submissions.

View all Grifols USA, LLC devices

FDA 510(k) Submission Details - K113377

510(k) Number K113377 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 16, 2011
Decision Date December 14, 2012
Days to Decision 394 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
290d slower than avg
Panel avg: 104d · This submission: 394d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MST Device Classification - Class 2, Special Controls

Product Code MST Antibodies, Gliadin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.5750
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Immunology devices follow this clearance model.

Regulatory Peers - MST Antibodies, Gliadin

All 29
Devices cleared under the same product code (MST) and FDA review panel - the closest regulatory comparables to K113377.
ImmuLisa Enhanced Gliadin IgA Antibody ELISA, ImmuLisa Enhanced Gliadin IgG Antibody ELISA
K163177 · Immco Diagnostics, Inc. · Jul 2017
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
IMMULISA CELIAC G+ (GLIADIN) IGA AND IGG ANTIBODY ELISA
K091522 · Immco Diagnostics, Inc. · Feb 2010
EUROIMMUN ANTI-GLIADIN (GAF-3X) ELISA (IGG)
K083053 · Euroimmun Us, Inc. · Aug 2009