Cleared Traditional

K946192 - HICHEM Y-GT REAGENT KIT

K946192 is the FDA 510(k) clearance for HICHEM Y-GT REAGENT KIT by Hichem Diagnostics. It is a Class 1 Chemistry device (product code JQB) cleared through the Traditional 510(k) pathway after a 133-day FDA review.

K946192 · Hichem Diagnostics · Chemistry device
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May 1995
Decision
133d
Days
Class 1
Risk

K946192 is an FDA 510(k) clearance for the HICHEM Y-GT REAGENT KIT. Classified as Kinetic Method, Gamma-glutamyl Transpeptidase (product code JQB), Class I - General Controls.

Submitted by Hichem Diagnostics (Brea, US). The FDA issued a Cleared decision on May 2, 1995 after a review of 133 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.

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Submission Details

510(k) Number K946192 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 20, 1994
Decision Date May 02, 1995
Days to Decision 133 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
45d slower than avg
Panel avg: 88d · This submission: 133d
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 K946192.
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
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