Cleared Traditional

Y-GLUTAMYLTRANSFERASE ASSAY, CATALOGUE NUMBER 308-05 (K945800) - FDA 510(k) Clearance

Class I Chemistry device.

K945800 · Diagnostic Chemicals , Ltd. · Chemistry device
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Jun 1995
Decision
193d
Days
Class 1
Risk

K945800 is an FDA 510(k) clearance for the Y-GLUTAMYLTRANSFERASE ASSAY, CATALOGUE NUMBER 308-05. Classified as Kinetic Method, Gamma-glutamyl Transpeptidase (product code JQB), Class I - General Controls.

Submitted by Diagnostic Chemicals , Ltd. (Charlottestown,Pei,Canada, CA). The FDA issued a Cleared decision on June 9, 1995 after a review of 193 days - an extended review cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1360 - the FDA in vitro diagnostics and chemistry 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 Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

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Submission Details

510(k) Number K945800 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 28, 1994
Decision Date June 09, 1995
Days to Decision 193 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
105d slower than avg
Panel avg: 88d · This submission: 193d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JQB Kinetic Method, Gamma-glutamyl Transpeptidase
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1360
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - JQB Kinetic Method, Gamma-glutamyl Transpeptidase

All 51
Devices cleared under the same product code (JQB) and FDA review panel - the closest regulatory comparables to K945800.
ROCHE COBAS IBTEGRA REAGENT CASSETTES
K964457 · Roche Diagnostic Systems, Inc. · Jan 1997
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ROCHE REAGENT FOR GGT
K924246 · Roche Diagnostic Systems, Inc. · Nov 1992
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K922947 · Em Diagnostic Systems, Inc. · Sep 1992
ABBOTT QUICKSTART GAMMA-GLUTAMYTRANSFERASE TEST
K913024 · Em Diagnostic Systems, Inc. · Jul 1991
SYSTEMATE GGT (EPOS APPLICATION) #65414
K905662 · Em Diagnostic Systems, Inc. · Jan 1991