Cleared Traditional

K924246 - ROCHE REAGENT FOR GGT

K924246 is the FDA 510(k) clearance for ROCHE REAGENT FOR GGT by Roche Diagnostic Systems, Inc.. It is a Class 1 Chemistry device (product code JQB) cleared through the Traditional 510(k) pathway after a 86-day FDA review.

K924246 · Roche Diagnostic Systems, Inc. · Chemistry device
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Nov 1992
Decision
86d
Days
Class 1
Risk

K924246 is an FDA 510(k) clearance for the ROCHE REAGENT FOR GGT. Classified as Kinetic Method, Gamma-glutamyl Transpeptidase (product code JQB), Class I - General Controls.

Submitted by Roche Diagnostic Systems, Inc. (Branchburg, US). The FDA issued a Cleared decision on November 18, 1992 after a review of 86 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Roche Diagnostic Systems, Inc. devices

Submission Details

510(k) Number K924246 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 24, 1992
Decision Date November 18, 1992
Days to Decision 86 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
2d faster than avg
Panel avg: 88d · This submission: 86d
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 40
Devices cleared under the same product code (JQB) and FDA review panel - the closest regulatory comparables to K924246.
GAMMA-GLUTAMYL TRANSFERASE (GGT) TEST
K935177 · Em Diagnostic Systems, Inc. · Dec 1993
SYNERMED GGT REAGENT KIT
K931958 · Synermed, Inc. · Sep 1993
OLYMPUS GAMMA GLUTAMYL TRANSFERASE REAGENT
K925337 · Olympus Corp. · Jan 1993
GAMMA GULTAMYL TRANSFERASE TEST
K922947 · Em Diagnostic Systems, Inc. · Sep 1992
OLYMPUS GGT REAGENT
K922230 · Olympus Corp. · Jun 1992
TRACE GAMMA GT-SS REAGENT
K914731 · Trace Scientific , Ltd. · Nov 1991