Cleared Traditional

K111414 - QUANTA FLASH (TM) DGP SCREEN

K111414 is the FDA 510(k) clearance for QUANTA FLASH (TM) DGP SCREEN by Inova Diagnostics, Inc.. It is a Class 2 Immunology device (product code MST) cleared through the Traditional 510(k) pathway after a 153-day FDA review.

K111414 · Inova Diagnostics, Inc. · Immunology device
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Oct 2011
Decision
153d
Days
Class 2
Risk

K111414 is an FDA 510(k) clearance for the QUANTA FLASH (TM) DGP SCREEN. Classified as Antibodies, Gliadin (product code MST), Class II - Special Controls.

Submitted by Inova Diagnostics, Inc. (San Diego, US). The FDA issued a Cleared decision on October 20, 2011 after a review of 153 days - an extended review cycle.

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. Standard predicate reliance. 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 Inova Diagnostics, Inc. devices

Submission Details

510(k) Number K111414 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 20, 2011
Decision Date October 20, 2011
Days to Decision 153 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
49d slower than avg
Panel avg: 104d · This submission: 153d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 20
Devices cleared under the same product code (MST) and FDA review panel - the closest regulatory comparables to K111414.
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
IMMULISA CELIAC G+ (GLIADIN) IGA AND IGG ANTIBODY ELISA
K091522 · Immco Diagnostics, Inc. · Feb 2010
BINDAZYME HUMAN ANTI-GLIADIN (MGP), IGG EIA KIT
K081674 · The Binding Site, Ltd. · Oct 2008
QUANTA LITE H-TTG/DGP SCREEN
K070083 · Inova Diagnostics, Inc. · Mar 2007
QUANTA LITE CELIAC DGP SCREEN
K062708 · Inova Diagnostics, Inc. · Dec 2006