Cleared Traditional

K955770 - GAMMA GLUTAMYL TRANSFERASE TEST SYSTEM

K955770 is an FDA 510(k) clearance for GAMMA GLUTAMYL TRANSFERASE TEST SYSTEM, manufactured by Abaxis, Inc.. The device is a Class 1 Chemistry device with product code JQB cleared through the Traditional 510(k) pathway after a 263-day FDA review.

K955770 · Abaxis, Inc. · Chemistry device
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Sep 1996
Decision
263d
Days
Class 1
Risk

K955770 is an FDA 510(k) clearance for the GAMMA GLUTAMYL TRANSFERASE TEST SYSTEM. Classified as Kinetic Method, Gamma-glutamyl Transpeptidase (product code JQB), Class I - General Controls.

Submitted by Abaxis, Inc. (Sunnyvale, US). The FDA issued a Cleared decision on September 9, 1996 after a review of 263 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.

View all Abaxis, Inc. devices

FDA 510(k) Submission Details - K955770

510(k) Number K955770 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 21, 1995
Decision Date September 09, 1996
Days to Decision 263 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
175d slower than avg
Panel avg: 88d · This submission: 263d
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 48
Devices cleared under the same product code (JQB) and FDA review panel - the closest regulatory comparables to K955770.
Y-GLUTAMYLTRANSFERASE-SL ASSAY , CATALOGE NUMBER 324-10, 324-30
K974000 · Diagnostic Chemicals , Ltd. · Nov 1997
LIQUID GGT (GAMMA GLUTAMYL TRANSFERASE) REAGENT SET
K973157 · Pointe Scientific, Inc., · Oct 1997
ROCHE COBAS IBTEGRA REAGENT CASSETTES
K964457 · Roche Diagnostic Systems, Inc. · Jan 1997
Y-GLUTAMYLTRANSFERASE ASSAY, CATALOGUE NUMBER 308-05
K945800 · Diagnostic Chemicals , Ltd. · Jun 1995
HICHEM Y-GT REAGENT KIT
K946192 · Hichem Diagnostics · May 1995
GGT QVET
K942962 · Prisma Systems · Dec 1994