Cleared Traditional

K961919 - DMA GAMMA GLUTAMYLTRANSFERASE (GGT) PRO...

K961919 is the FDA 510(k) clearance for DMA GAMMA GLUTAMYLTRANSFERASE (GGT) PRO... by Data Medical Associates, Inc.. It is a Class 1 Chemistry device (product code JPZ) cleared through the Traditional 510(k) pathway after a 45-day FDA review.

K961919 · Data Medical Associates, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1996
Decision
45d
Days
Class 1
Risk

K961919 is an FDA 510(k) clearance for the DMA GAMMA GLUTAMYLTRANSFERASE (GGT) PROCEDURE. Classified as Colorimetric Method, Gamma-glutamyl Transpeptidase (product code JPZ), Class I - General Controls.

Submitted by Data Medical Associates, Inc. (Arlington, US). The FDA issued a Cleared decision on July 1, 1996 after a review of 45 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 Data Medical Associates, Inc. devices

Submission Details

510(k) Number K961919 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 17, 1996
Decision Date July 01, 1996
Days to Decision 45 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
43d faster than avg
Panel avg: 88d · This submission: 45d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JPZ Colorimetric 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 - JPZ Colorimetric Method, Gamma-glutamyl Transpeptidase

All 20
Devices cleared under the same product code (JPZ) and FDA review panel - the closest regulatory comparables to K961919.
GAMMA-GT
K923509 · Randox Laboratories, Ltd. · Dec 1992
KING DIAGNOSTICS GAMMA GT REAGENT
K923091 · King Diagnostics, Inc. · Sep 1992
GGT REAGENT
K905618 · Amresco, Inc. · Feb 1991
ROCHE COBAS READY GGT REAGENT
K903304 · Roche Diagnostic Systems, Inc. · Oct 1990
WAKO(TM) AUTOKIT GAMMA-GT
K895984 · Wako Chemicals USA, Inc. · Nov 1989
VISION (TM) GGTP
K864208 · Abbott Laboratories · Nov 1986