Cleared Traditional

K903304 - ROCHE COBAS READY GGT REAGENT

K903304 is an FDA 510(k) clearance for ROCHE COBAS READY GGT REAGENT, manufactured by Roche Diagnostic Systems, Inc.. The device is a Class 1 Chemistry device with product code JPZ cleared through the Traditional 510(k) pathway after a 80-day FDA review.

K903304 · Roche Diagnostic Systems, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1990
Decision
80d
Days
Class 1
Risk

K903304 is an FDA 510(k) clearance for the ROCHE COBAS READY GGT REAGENT. Classified as Colorimetric Method, Gamma-glutamyl Transpeptidase (product code JPZ), Class I - General Controls.

Submitted by Roche Diagnostic Systems, Inc. (Montclair, US). The FDA issued a Cleared decision on October 12, 1990 after a review of 80 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

FDA 510(k) Submission Details - K903304

510(k) Number K903304 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 24, 1990
Decision Date October 12, 1990
Days to Decision 80 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
8d faster than avg
Panel avg: 88d · This submission: 80d
Pathway characteristics
Predicate-based equivalence.

JPZ Device Classification - Class 1, General Controls

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 27
Devices cleared under the same product code (JPZ) and FDA review panel - the closest regulatory comparables to K903304.
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
WAKO(TM) AUTOKIT GAMMA-GT
K895984 · Wako Chemicals USA, Inc. · Nov 1989
GAMMA GLUTAMYL TRANSFERASE REAGENT SET
K881239 · Tech-Neal Scientific, Inc. · May 1988
MULTICHEM(R) Y -GLUTAMYLTRANSFERASE (Y -GT)
K874903 · Simmler, Inc. · Feb 1988