Cleared Traditional

K970867 - URIC ACID REAGENT

K970867 is an FDA 510(k) clearance for URIC ACID REAGENT, manufactured by Derma Media Lab., Inc.. The device is a Class 1 Chemistry device with product code KNK cleared through the Traditional 510(k) pathway after a 42-day FDA review.

K970867 · Derma Media Lab., Inc. · Chemistry device
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Apr 1997
Decision
42d
Days
Class 1
Risk

K970867 is an FDA 510(k) clearance for the URIC ACID REAGENT. Classified as Acid, Uric, Uricase (colorimetric) (product code KNK), Class I - General Controls.

Submitted by Derma Media Lab., Inc. (Santa Fe Springs, US). The FDA issued a Cleared decision on April 21, 1997 after a review of 42 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 Derma Media Lab., Inc. devices

FDA 510(k) Submission Details - K970867

510(k) Number K970867 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 10, 1997
Decision Date April 21, 1997
Days to Decision 42 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
46d faster than avg
Panel avg: 88d · This submission: 42d
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 K970867.
URIC ACID, MODEL UA112-01
K991247 · A.P. Total Care, Inc. · May 1999
CARESIDE URIC ACID
K981604 · Careside, Inc. · Jun 1998
SYNCHRON CX SYSTEMS URIC ACID (URIC) REAGENT
K970919 · Beckman Instruments, Inc. · May 1997
URIC, UA, OR URIC ACID
K971133 · Carolina Liquid Chemistries Corp. · Apr 1997
URIC ACID (LIQUID) REAGENT SET
K970560 · Pointe Scientific, Inc., · Mar 1997
URIC ACID-SL ASSAY CATALOGUE NO. 237-60
K961586 · Diagnostic Chemicals , Ltd. · Jul 1996