Cleared Traditional

K801243 - COBAS REAGENTS FOR URIC ACID

K801243 is an FDA 510(k) clearance for COBAS REAGENTS FOR URIC ACID, manufactured by Roche Analytical Instruments, Inc.. The device is a Class 1 Chemistry device with product code CDO cleared through the Traditional 510(k) pathway after a 30-day FDA review.

K801243 · Roche Analytical Instruments, Inc. · Chemistry device
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Jun 1980
Decision
30d
Days
Class 1
Risk

K801243 is an FDA 510(k) clearance for the COBAS REAGENTS FOR URIC ACID. Classified as Acid, Uric, Uricase (u.v.) (product code CDO), Class I - General Controls.

Submitted by Roche Analytical Instruments, Inc. (Mchenry, US). The FDA issued a Cleared decision on June 26, 1980 after a review of 30 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 Analytical Instruments, Inc. devices

FDA 510(k) Submission Details - K801243

510(k) Number K801243 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 27, 1980
Decision Date June 26, 1980
Days to Decision 30 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
58d faster than avg
Panel avg: 88d · This submission: 30d
Pathway characteristics
Predicate-based equivalence.

CDO Device Classification - Class 1, General Controls

Product Code CDO Acid, Uric, Uricase (u.v.)
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 - CDO Acid, Uric, Uricase (u.v.)

All 27
Devices cleared under the same product code (CDO) and FDA review panel - the closest regulatory comparables to K801243.
URICASE (U.V.) URIC ACID
K821167 · Syn-Kit, Inc. · May 1982
ULTRACHEM URIC ACID ALDH, ITEM #65047
K812500 · Harleco · Sep 1981
URIC ACID/ALDH
K802371 · Boehringer Mannheim Corp. · Oct 1980
CENTRIFICHEM URIC ACID
K800130 · Union Carbide Corp. · Feb 1980
UV URIC ACID DETERMINATION
K790834 · The Dow Chemical Co. · Jun 1979
ACID REAGENT, URIC SINGLE VIAL
K781996 · Calbiochem-Behring Corp. · Jan 1979