Cleared Traditional

K964916 - GAMMA-GLUTAMYL TRANSPEPTIDASE

K964916 is an FDA 510(k) clearance for GAMMA-GLUTAMYL TRANSPEPTIDASE, manufactured by Derma Media Lab., Inc.. The device is a Class 1 Chemistry device with product code JQB cleared through the Traditional 510(k) pathway after a 32-day FDA review.

K964916 · Derma Media Lab., Inc. · Chemistry device
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Jan 1997
Decision
32d
Days
Class 1
Risk

K964916 is an FDA 510(k) clearance for the GAMMA-GLUTAMYL TRANSPEPTIDASE. Classified as Kinetic Method, Gamma-glutamyl Transpeptidase (product code JQB), Class I - General Controls.

Submitted by Derma Media Lab., Inc. (Santa Fe Springs, US). The FDA issued a Cleared decision on January 10, 1997 after a review of 32 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 Derma Media Lab., Inc. devices

FDA 510(k) Submission Details - K964916

510(k) Number K964916 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 09, 1996
Decision Date January 10, 1997
Days to Decision 32 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
56d faster than avg
Panel avg: 88d · This submission: 32d
Pathway characteristics
Predicate-based equivalence.

JQB Device Classification - Class 1, General Controls

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 K964916.
LIQUID GGT (GAMMA GLUTAMYL TRANSFERASE) REAGENT SET
K973157 · Pointe Scientific, Inc., · Oct 1997
SYNCHRON CX SYSTEMS GAMMA-GLUTAMYL TRANSFERASE REAGENT (GGT)
K971466 · Carolina Liquid Chemistries Corp. · May 1997
ROCHE COBAS IBTEGRA REAGENT CASSETTES
K964457 · Roche Diagnostic Systems, Inc. · Jan 1997
GAMMA GLUTAMYL TRANSFERASE TEST SYSTEM
K955770 · Abaxis, Inc. · Sep 1996
Y-GLUTAMYLTRANSFERASE ASSAY, CATALOGUE NUMBER 308-05
K945800 · Diagnostic Chemicals , Ltd. · Jun 1995
HICHEM Y-GT REAGENT KIT
K946192 · Hichem Diagnostics · May 1995