Cleared Traditional

K163177 - ImmuLisa Enhanced Gliadin IgA Antibody ELISA, ImmuLisa Enhanced Gliadin IgG Antibody ELISA

K163177 is an FDA 510(k) clearance for ImmuLisa Enhanced Gliadin IgA Antibody ..., manufactured by Immco Diagnostics, Inc.. The device is a Class 2 Immunology device with product code MST cleared through the Traditional 510(k) pathway after a 256-day FDA review.

K163177 · Immco Diagnostics, Inc. · Immunology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jul 2017
Decision
256d
Days
Class 2
Risk

K163177 is an FDA 510(k) clearance for the ImmuLisa Enhanced Gliadin IgA Antibody ELISA, ImmuLisa Enhanced Gliadin IgG A.... Classified as Antibodies, Gliadin (product code MST), Class II - Special Controls.

Submitted by Immco Diagnostics, Inc. (Clarence, US). The FDA issued a Cleared decision on July 28, 2017 after a review of 256 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 Immco Diagnostics, Inc. devices

FDA 510(k) Submission Details - K163177

510(k) Number K163177 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 14, 2016
Decision Date July 28, 2017
Days to Decision 256 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
151d slower than avg
Panel avg: 105d · This submission: 256d
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 41
Devices cleared under the same product code (MST) and FDA review panel - the closest regulatory comparables to K163177.
AESKULISA DGP-A, AESKULISA DGP-G,AESKULISA DGP-CHECK
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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