Cleared Traditional

K931958 - SYNERMED GGT REAGENT KIT

K931958 is the FDA 510(k) clearance for SYNERMED GGT REAGENT KIT by Synermed, Inc.. It is a Class 1 Chemistry device (product code JQB) cleared through the Traditional 510(k) pathway after a 141-day FDA review.

K931958 · Synermed, Inc. · Chemistry device
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Sep 1993
Decision
141d
Days
Class 1
Risk

K931958 is an FDA 510(k) clearance for the SYNERMED GGT REAGENT KIT. Classified as Kinetic Method, Gamma-glutamyl Transpeptidase (product code JQB), Class I - General Controls.

Submitted by Synermed, Inc. (Quebec, Canada, CA). The FDA issued a Cleared decision on September 8, 1993 after a review of 141 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 Synermed, Inc. devices

Submission Details

510(k) Number K931958 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 20, 1993
Decision Date September 08, 1993
Days to Decision 141 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
53d slower than avg
Panel avg: 88d · This submission: 141d
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 45
Devices cleared under the same product code (JQB) and FDA review panel - the closest regulatory comparables to K931958.
GLUTAMYL-TRANSFERASE, PROCEDURE NO. 419
K935984 · Sigma Diagnostics, Inc. · Jul 1994
STANBIO Y-GT (LIQUICOLOR) TEST SET
K941315 · Stanbio Laboratory · Jul 1994
GAMMA-GLUTAMYL TRANSFERASE (GGT) TEST
K935177 · Em Diagnostic Systems, Inc. · Dec 1993
OLYMPUS GAMMA GLUTAMYL TRANSFERASE REAGENT
K925337 · Olympus Corp. · Jan 1993
ROCHE REAGENT FOR GGT
K924246 · Roche Diagnostic Systems, Inc. · Nov 1992
GAMMA GULTAMYL TRANSFERASE TEST
K922947 · Em Diagnostic Systems, Inc. · Sep 1992