Cleared Traditional

K905649 - GAMMA-GLUTAMYL TRANSFERASE DETERMINATION

K905649 is the FDA 510(k) clearance for GAMMA-GLUTAMYL TRANSFERASE DETERMINATION by Biochemical Trade, Inc.. It is a Class 1 Chemistry device (product code JQB) cleared through the Traditional 510(k) pathway after a 43-day FDA review.

K905649 · Biochemical Trade, Inc. · Chemistry device
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Jan 1991
Decision
43d
Days
Class 1
Risk

K905649 is an FDA 510(k) clearance for the GAMMA-GLUTAMYL TRANSFERASE DETERMINATION. Classified as Kinetic Method, Gamma-glutamyl Transpeptidase (product code JQB), Class I - General Controls.

Submitted by Biochemical Trade, Inc. (Miami, US). The FDA issued a Cleared decision on January 30, 1991 after a review of 43 days - a notably fast clearance 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: 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 Biochemical Trade, Inc. devices

Submission Details

510(k) Number K905649 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 18, 1990
Decision Date January 30, 1991
Days to Decision 43 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
45d faster than avg
Panel avg: 88d · This submission: 43d
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 46
Devices cleared under the same product code (JQB) and FDA review panel - the closest regulatory comparables to K905649.
OLYMPUS GGT REAGENT
K922230 · Olympus Corp. · Jun 1992
TRACE GAMMA GT-SS REAGENT
K914731 · Trace Scientific , Ltd. · Nov 1991
ABBOTT QUICKSTART GAMMA-GLUTAMYTRANSFERASE TEST
K913024 · Em Diagnostic Systems, Inc. · Jul 1991
SYSTEMATE GGT (EPOS APPLICATION) #65414
K905662 · Em Diagnostic Systems, Inc. · Jan 1991
RAICHEM GGT REAGENT
K905085 · Reagents Applications, Inc. · Dec 1990
GGT REAGENTS, 7738, 7739, 7538, 7438 & 7138
K905096 · Amresco, Inc. · Nov 1990