Cleared Traditional

OLYMPUS GAMMA GLUTAMYL TRANSFERASE REAGENT (K925337) - FDA 510(k) Clearance

Class I Chemistry device.

K925337 · Olympus Corp. · Chemistry device
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Jan 1993
Decision
98d
Days
Class 1
Risk

K925337 is an FDA 510(k) clearance for the OLYMPUS GAMMA GLUTAMYL TRANSFERASE REAGENT. Classified as Kinetic Method, Gamma-glutamyl Transpeptidase (product code JQB), Class I - General Controls.

Submitted by Olympus Corp. (Lake Success, US). The FDA issued a Cleared decision on January 26, 1993 after a review of 98 days - within the typical 510(k) review window.

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 Olympus Corp. devices

Submission Details

510(k) Number K925337 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 20, 1992
Decision Date January 26, 1993
Days to Decision 98 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
10d slower than avg
Panel avg: 88d · This submission: 98d
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 17
Devices cleared under the same product code (JQB) and FDA review panel - the closest regulatory comparables to K925337.
ROCHE COBAS IBTEGRA REAGENT CASSETTES
K964457 · Roche Diagnostic Systems, Inc. · Jan 1997
GLUTAMYL-TRANSFERASE, PROCEDURE NO. 419
K935984 · Sigma Diagnostics, Inc. · Jul 1994
GAMMA-GLUTAMYL TRANSFERASE (GGT) TEST
K935177 · Em Diagnostic Systems, Inc. · Dec 1993
ROCHE REAGENT FOR GGT
K924246 · Roche Diagnostic Systems, Inc. · Nov 1992
GAMMA GULTAMYL TRANSFERASE TEST
K922947 · Em Diagnostic Systems, Inc. · Sep 1992
OLYMPUS GGT REAGENT
K922230 · Olympus Corp. · Jun 1992