Cleared Traditional

GAMMA GLUTAMYL TRANSFERASE TEST, ITEM: 65414/R1 (K893765) - FDA 510(k) Clearance

Class I Chemistry device.

K893765 · Em Diagnostic Systems, Inc. · Chemistry device
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Jul 1989
Decision
62d
Days
Class 1
Risk

K893765 is an FDA 510(k) clearance for the GAMMA GLUTAMYL TRANSFERASE TEST, ITEM: 65414/R1. 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 July 20, 1989 after a review of 62 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 Em Diagnostic Systems, Inc. devices

Submission Details

510(k) Number K893765 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 19, 1989
Decision Date July 20, 1989
Days to Decision 62 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
26d faster than avg
Panel avg: 88d · This submission: 62d
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 51
Devices cleared under the same product code (JQB) and FDA review panel - the closest regulatory comparables to K893765.
ROCHE COBAS IBTEGRA REAGENT CASSETTES
K964457 · Roche Diagnostic Systems, Inc. · Jan 1997
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
ABBOTT QUICKSTART GAMMA-GLUTAMYTRANSFERASE TEST
K913024 · Em Diagnostic Systems, Inc. · Jul 1991
SYSTEMATE GGT (EPOS APPLICATION) #65414
K905662 · Em Diagnostic Systems, Inc. · Jan 1991