Cleared Traditional

K102964 - EU-TTG IGA AND EU-TTG IGG

K102964 is an FDA 510(k) clearance for EU-TTG IGA AND EU-TTG IGG, manufactured by Grifols USA, Inc.. The device is a Class 2 Immunology device with product code MVM cleared through the Traditional 510(k) pathway after a 153-day FDA review.

K102964 · Grifols USA, Inc. · Immunology device
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Mar 2011
Decision
153d
Days
Class 2
Risk

K102964 is an FDA 510(k) clearance for the EU-TTG IGA AND EU-TTG IGG. Classified as Autoantibodies, Endomysial(tissue Transglutaminase) (product code MVM), Class II - Special Controls.

Submitted by Grifols USA, Inc. (Los Angeles, US). The FDA issued a Cleared decision on March 7, 2011 after a review of 153 days - an extended review cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.5660 - 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 Grifols USA, Inc. devices

FDA 510(k) Submission Details - K102964

510(k) Number K102964 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 05, 2010
Decision Date March 07, 2011
Days to Decision 153 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
48d slower than avg
Panel avg: 105d · This submission: 153d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MVM Device Classification - Class 2, Special Controls

Product Code MVM Autoantibodies, Endomysial(tissue Transglutaminase)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.5660
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 - MVM Autoantibodies, Endomysial(tissue Transglutaminase)

All 26
Devices cleared under the same product code (MVM) and FDA review panel - the closest regulatory comparables to K102964.
IMMULISA ENHANCED CELIAC FUSION (TTG/DGP) IGA/IGG ANTIBODY ELISA
K123713 · Immco Diagnostics, Inc. · Oct 2013
BIOPLEX 2200 CELIAC IGA AND IGG KITS ON THE BIOPLEX 2200 SYSTEM, BIOPLEX 2200 CELIAC IGA AND IGG CALIBRATOR SETS, AND BI
K130053 · Bio-Rad Laboratories, Inc. · Sep 2013
QUANTA FLASH H-TTG IGG
K101644 · Inova Diagnostics, Inc. · Mar 2011
QUANTA FLASH H-TTG IGA
K094060 · Inova Diagnostics, Inc. · Oct 2010
IMMULISA CELIAC TTG IGA AND IGG ANTIBODY ELISA
K091520 · Immco Diagnostics, Inc. · Mar 2010
QUANTA LITE H-TTG SCREEN
K073145 · Inova Diagnostics, Inc. · Feb 2008