Cleared Traditional

K052793 - IMMUNOCAP/UNICAP GLIADIN IGA, IMMUNOCAP/UNICAP SPECIFIC IGA, MODELS 14-4425-40, 10-9306-02

K052793 is an FDA 510(k) clearance for IMMUNOCAP/UNICAP GLIADIN IGA, manufactured by Pharmacia Diagnostics AB. The device is a Class 2 Immunology device with product code MST cleared through the Traditional 510(k) pathway after a 127-day FDA review.

K052793 · Pharmacia Diagnostics AB · Immunology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2006
Decision
127d
Days
Class 2
Risk

K052793 is an FDA 510(k) clearance for the IMMUNOCAP/UNICAP GLIADIN IGA, IMMUNOCAP/UNICAP SPECIFIC IGA, MODELS 14-4425-4.... Classified as Antibodies, Gliadin (product code MST), Class II - Special Controls.

Submitted by Pharmacia Diagnostics AB (Portage, US). The FDA issued a Cleared decision on February 7, 2006 after a review of 127 days - within the typical 510(k) review window.

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 Pharmacia Diagnostics AB devices

FDA 510(k) Submission Details - K052793

510(k) Number K052793 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 03, 2005
Decision Date February 07, 2006
Days to Decision 127 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
22d slower than avg
Panel avg: 105d · This submission: 127d
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 30
Devices cleared under the same product code (MST) and FDA review panel - the closest regulatory comparables to K052793.
ELIA GLIADIN IGA, IGG AND CELIAC CONTROL
K063775 · Phadia US, Inc. · Mar 2007
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
QUANTA LITE GLIADIN IGA II
K052143 · Inova Diagnostics, Inc. · Oct 2005
DIAMEDIX IS-ANTI-GLIADIN IGG TEST SYSTEM
K012795 · Diamedix Corp. · Sep 2001