Cleared Traditional

K063775 - ELIA GLIADIN IGA

K063775 is an FDA 510(k) clearance for ELIA GLIADIN IGA, manufactured by Phadia US, Inc.. The device is a Class 2 Immunology device with product code MST cleared through the Traditional 510(k) pathway after a 83-day FDA review.

K063775 · Phadia US, Inc. · Immunology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2007
Decision
83d
Days
Class 2
Risk

K063775 is an FDA 510(k) clearance for the ELIA GLIADIN IGA, IGG AND CELIAC CONTROL. Classified as Antibodies, Gliadin (product code MST), Class II - Special Controls.

Submitted by Phadia US, Inc. (Portage, US). The FDA issued a Cleared decision on March 14, 2007 after a review of 83 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Phadia US, Inc. devices

FDA 510(k) Submission Details - K063775

510(k) Number K063775 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 21, 2006
Decision Date March 14, 2007
Days to Decision 83 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
21d faster than avg
Panel avg: 104d · This submission: 83d
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 24
Devices cleared under the same product code (MST) and FDA review panel - the closest regulatory comparables to K063775.
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
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
QUANTA LITE GLIADIN IGG II
K052142 · Inova Diagnostics, Inc. · Oct 2005