Cleared Traditional

K964457 - ROCHE COBAS IBTEGRA REAGENT CASSETTES

K964457 is the FDA 510(k) clearance for ROCHE COBAS IBTEGRA REAGENT CASSETTES by Roche Diagnostic Systems, Inc.. It is a Class 1 Chemistry device (product code JQB) cleared through the Traditional 510(k) pathway after a 68-day FDA review.

K964457 · Roche Diagnostic Systems, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1997
Decision
68d
Days
Class 1
Risk

K964457 is an FDA 510(k) clearance for the ROCHE COBAS IBTEGRA REAGENT CASSETTES. 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 January 13, 1997 after a review of 68 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 K964457 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 06, 1996
Decision Date January 13, 1997
Days to Decision 68 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
20d faster than avg
Panel avg: 88d · This submission: 68d
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 K964457.
Y-GLUTAMYLTRANSFERASE-SL ASSAY , CATALOGE NUMBER 324-10, 324-30
K974000 · Diagnostic Chemicals , Ltd. · Nov 1997
LIQUID GGT (GAMMA GLUTAMYL TRANSFERASE) REAGENT SET
K973157 · Pointe Scientific, Inc., · Oct 1997
Y-GLUTAMYLTRANSFERASE ASSAY, CATALOGUE NUMBER 308-05
K945800 · Diagnostic Chemicals , Ltd. · Jun 1995
GLUTAMYL-TRANSFERASE, PROCEDURE NO. 419
K935984 · Sigma Diagnostics, Inc. · Jul 1994
STANBIO Y-GT (LIQUICOLOR) TEST SET
K941315 · Stanbio Laboratory · Jul 1994
GAMMA-GLUTAMYL TRANSFERASE (GGT) TEST
K935177 · Em Diagnostic Systems, Inc. · Dec 1993