Cleared Traditional

K896225 - COBAS READY PROFILE 2 REAGENT STRIP

K896225 is the FDA 510(k) clearance for COBAS READY PROFILE 2 REAGENT STRIP by Roche Diagnostic Systems, Inc.. It is a Class 1 Chemistry device (product code KNK) cleared through the Traditional 510(k) pathway after a 239-day FDA review.

K896225 · Roche Diagnostic Systems, Inc. · Chemistry device
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Jun 1990
Decision
239d
Days
Class 1
Risk

K896225 is an FDA 510(k) clearance for the COBAS READY PROFILE 2 REAGENT STRIP. Classified as Acid, Uric, Uricase (colorimetric) (product code KNK), Class I - General Controls.

Submitted by Roche Diagnostic Systems, Inc. (Montclair, US). The FDA issued a Cleared decision on June 26, 1990 after a review of 239 days - an extended review cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1775 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all Roche Diagnostic Systems, Inc. devices

Submission Details

510(k) Number K896225 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 30, 1989
Decision Date June 26, 1990
Days to Decision 239 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
151d slower than avg
Panel avg: 88d · This submission: 239d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code KNK Acid, Uric, Uricase (colorimetric)
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1775
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 - KNK Acid, Uric, Uricase (colorimetric)

All 67
Devices cleared under the same product code (KNK) and FDA review panel - the closest regulatory comparables to K896225.
ROCHE REAGENT FOR URIC ACID--MODIFICATION
K922762 · Roche Diagnostic Systems, Inc. · Jul 1992
ABBOTT QUICKSTART URIC ACID TEST (URCA) ITEM# 5A34
K913706 · Em Diagnostic Systems, Inc. · Sep 1991
SYNERMED URIC ACID REAGENT KIT
K903727 · Synermed, Inc. · Sep 1990
WAKO(TM) AUTOKIT URIC ACID
K901544 · Wako Chemicals USA, Inc. · May 1990
TECHNICON CHEM 1 CLINICAL ANALYZER FOR URINE URIC
K901693 · Technicon Instruments Corp. · Apr 1990
COULTER URIC ACID REAGENT
K897161 · Coulter Electronics, Inc. · Mar 1990