Cleared Traditional

K071692 - THERATEST EL-TTG IGA/IGG AND THERATEST EL-GLIA IGA/IGG TEST SYSTEMS

K071692 is an FDA 510(k) clearance for THERATEST EL-TTG IGA/IGG AND THERATEST ..., manufactured by Theratest Laboratories, Inc.. The device is a Class 2 Immunology device with product code MVM cleared through the Traditional 510(k) pathway after a 138-day FDA review.

K071692 · Theratest Laboratories, Inc. · Immunology device
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Nov 2007
Decision
138d
Days
Class 2
Risk

K071692 is an FDA 510(k) clearance for the THERATEST EL-TTG IGA/IGG AND THERATEST EL-GLIA IGA/IGG TEST SYSTEMS. Classified as Autoantibodies, Endomysial(tissue Transglutaminase) (product code MVM), Class II - Special Controls.

Submitted by Theratest Laboratories, Inc. (Lombard, US). The FDA issued a Cleared decision on November 5, 2007 after a review of 138 days - within the typical 510(k) review window.

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 Theratest Laboratories, Inc. devices

FDA 510(k) Submission Details - K071692

510(k) Number K071692 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 20, 2007
Decision Date November 05, 2007
Days to Decision 138 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
33d slower than avg
Panel avg: 105d · This submission: 138d
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 28
Devices cleared under the same product code (MVM) and FDA review panel - the closest regulatory comparables to K071692.
QUANTA LITE H-TTG SCREEN
K073145 · Inova Diagnostics, Inc. · Feb 2008
QUANTA PLEX CELIAC IGG PROFILE
K072632 · Inova Diagnostics, Inc. · Feb 2008
QUANTA LITE F-ACTIN IGA ELISA
K072967 · Inova Diagnostics, Inc. · Jan 2008
QUANTA PLEX CELIAC IGA PROFILE
K063818 · Inova Diagnostics, Inc. · Jun 2007
ELIA CELIKEY IGA WELL, MODEL 14-5517-01
K062787 · Phadia US, Inc. · Dec 2006
ELIA CELIKEY IGG WELL, MODEL 14-5518-01, ELIA CELIAC CONTROL, MODEL 83-1011-01
K062583 · Phadia US, Inc. · Dec 2006