Cleared Traditional

COBAS READY PROFILE 2 REAGENT STRIP (K896225) - FDA 510(k) Clearance

Class I Chemistry device.

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 117
Devices cleared under the same product code (KNK) and FDA review panel - the closest regulatory comparables to K896225.
URIC ACID MODEL 3P39
K102568 · Abbott Laboratories · May 2011
IL TEST URIC ACID
K931350 · Instrumentation Laboratory CO · Oct 1993
ROCHE REAGENT FOR URIC ACID--MODIFICATION
K922762 · Roche Diagnostic Systems, Inc. · Jul 1992
ABBOTT SPECTRUM URIC ACID REAGENT KIT
K896954 · Abbott Laboratories · Feb 1990
COBAS READY URIC ACID REAGENT
K896227 · Roche Diagnostic Systems, Inc. · Feb 1990
MODIFIED PARAMAX URIC ACID REAGENT
K896521 · Baxter Healthcare Corp · Feb 1990