Cleared Traditional

K955770 - GAMMA GLUTAMYL TRANSFERASE TEST SYSTEM (FDA 510(k) Clearance)

Class I Chemistry device.

K955770 · Abaxis, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

Submission Details

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.

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.