Cleared Traditional

K922947 - GAMMA GULTAMYL TRANSFERASE TEST

K922947 is an FDA 510(k) clearance for GAMMA GULTAMYL TRANSFERASE TEST, manufactured by Em Diagnostic Systems, Inc.. The device is a Class 1 Chemistry device with product code JQB cleared through the Traditional 510(k) pathway after a 102-day FDA review.

K922947 · Em Diagnostic Systems, Inc. · Chemistry device
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Sep 1992
Decision
102d
Days
Class 1
Risk

K922947 is an FDA 510(k) clearance for the GAMMA GULTAMYL TRANSFERASE TEST. Classified as Kinetic Method, Gamma-glutamyl Transpeptidase (product code JQB), Class I - General Controls.

Submitted by Em Diagnostic Systems, Inc. (Gibbstown, US). The FDA issued a Cleared decision on September 28, 1992 after a review of 102 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 Em Diagnostic Systems, Inc. devices

FDA 510(k) Submission Details - K922947

510(k) Number K922947 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 18, 1992
Decision Date September 28, 1992
Days to Decision 102 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
14d slower than avg
Panel avg: 88d · This submission: 102d
Pathway characteristics
Predicate-based equivalence.

JQB Device Classification - Class 1, General Controls

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 51
Devices cleared under the same product code (JQB) and FDA review panel - the closest regulatory comparables to K922947.
SYNERMED GGT REAGENT KIT
K931958 · Synermed, Inc. · Sep 1993
OLYMPUS GAMMA GLUTAMYL TRANSFERASE REAGENT
K925337 · Olympus Corp. · Jan 1993
ROCHE REAGENT FOR GGT
K924246 · Roche Diagnostic Systems, Inc. · Nov 1992
OLYMPUS GGT REAGENT
K922230 · Olympus Corp. · Jun 1992
TRACE GAMMA GT-SS REAGENT
K914731 · Trace Scientific , Ltd. · Nov 1991
ABBOTT QUICKSTART GAMMA-GLUTAMYTRANSFERASE TEST
K913024 · Em Diagnostic Systems, Inc. · Jul 1991