Cleared Traditional

K972250 - ROCHE COBAS INTEGRA REAGENT CASSETTES &...

K972250 is the FDA 510(k) clearance for ROCHE COBAS INTEGRA REAGENT CASSETTES &... by Roche Diagnostic Systems, Inc.. It is a Class 2 Chemistry device (product code JFJ) cleared through the Traditional 510(k) pathway after a 57-day FDA review.

K972250 · Roche Diagnostic Systems, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1997
Decision
57d
Days
Class 2
Risk

K972250 is an FDA 510(k) clearance for the ROCHE COBAS INTEGRA REAGENT CASSETTES & ANCILLARY REAGENTS. Classified as Catalytic Methods, Amylase (product code JFJ), Class II - Special Controls.

Submitted by Roche Diagnostic Systems, Inc. (Somerville, US). The FDA issued a Cleared decision on August 12, 1997 after a review of 57 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1070 - 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 K972250 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 16, 1997
Decision Date August 12, 1997
Days to Decision 57 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
31d faster than avg
Panel avg: 88d · This submission: 57d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JFJ Catalytic Methods, Amylase
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1070
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Chemistry devices follow this clearance model.

Regulatory Peers - JFJ Catalytic Methods, Amylase

All 70
Devices cleared under the same product code (JFJ) and FDA review panel - the closest regulatory comparables to K972250.
AMY
K981216 · Abbott Laboratories · Jun 1998
IL TEST AMYLASE
K974125 · Instrumentation Laboratory CO · Dec 1997
AMYLASE-SL ASSAY CATALOGUE NUMBER 341-10
K974053 · Diagnostic Chemicals , Ltd. · Dec 1997
PANCREATIC AMYLASE, ETHYLIDENE BLOCKED-PNPG7 ENZYME COLORIMETRIC TEST
K971825 · Randox Laboratories, Ltd. · Jul 1997
CATALOGUE NUMBER 321-07/15/50
K945243 · Diagnostic Chemicals , Ltd. · Feb 1995
OLYMPUS AMYLASE REAGENT
K944229 · Olympus America, Inc. · Dec 1994