Cleared Traditional

ROCHE REAGENT FOR URIC ACID--MODIFICATION (K922762) - FDA 510(k) Clearance

Class I Chemistry device.

K922762 · Roche Diagnostic Systems, Inc. · Chemistry device
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Jul 1992
Decision
51d
Days
Class 1
Risk

K922762 is an FDA 510(k) clearance for the ROCHE REAGENT FOR URIC ACID--MODIFICATION. Classified as Acid, Uric, Uricase (colorimetric) (product code KNK), Class I - General Controls.

Submitted by Roche Diagnostic Systems, Inc. (Branchburg, US). The FDA issued a Cleared decision on July 9, 1992 after a review of 51 days - a notably fast clearance 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: 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 K922762 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 19, 1992
Decision Date July 09, 1992
Days to Decision 51 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
37d faster than avg
Panel avg: 88d · This submission: 51d
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 K922762.
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COBAS READY PROFILE 2 REAGENT STRIP
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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