Cleared Traditional

K896225 - COBAS READY PROFILE 2 REAGENT STRIP

K896225 is an FDA 510(k) clearance for COBAS READY PROFILE 2 REAGENT STRIP, manufactured by Roche Diagnostic Systems, Inc.. The device is a Class 1 Chemistry device with 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

FDA 510(k) Submission Details - K896225

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.

KNK Device Classification - Class 1, General Controls

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 100
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