Cleared Traditional

K894101 - ROCHE REAGENT FOR URIC ACID

K894101 is the FDA 510(k) clearance for ROCHE REAGENT FOR URIC ACID by Roche Diagnostic Systems, Inc.. It is a Class 1 Chemistry device (product code KNK) cleared through the Traditional 510(k) pathway after a 88-day FDA review.

K894101 · Roche Diagnostic Systems, Inc. · Chemistry device
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Sep 1989
Decision
88d
Days
Class 1
Risk

K894101 is an FDA 510(k) clearance for the ROCHE REAGENT FOR URIC ACID. 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 September 5, 1989 after a review of 88 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 K894101 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 09, 1989
Decision Date September 05, 1989
Days to Decision 88 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
At panel average
Panel avg: 88d · This submission: 88d
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 K894101.
COBAS READY URIC ACID REAGENT
K896227 · Roche Diagnostic Systems, Inc. · Feb 1990
MODIFIED PARAMAX URIC ACID REAGENT
K896521 · Baxter Healthcare Corp · Feb 1990
URIC ACID PAP
K895665 · Boehringer Mannheim Corp. · Oct 1989
URIC ACID TEST ITEM NUMBER 65422
K894287 · Em Diagnostic Systems, Inc. · Aug 1989
URIC ACID REAGENT (PROCEDURE NUMBER 686)
K893416 · Sigma Chemical Co. · Jun 1989
AMRESCO URIC ACID REAGENTS #7628
K892395 · American Research Products Co. · May 1989