Cleared Traditional

K841067 - URIC ACID REAGENT SET

K841067 is an FDA 510(k) clearance for URIC ACID REAGENT SET, manufactured by Medical Specialties, Inc.. The device is a Class 1 Chemistry device with product code CDH cleared through the Traditional 510(k) pathway after a 50-day FDA review.

K841067 · Medical Specialties, Inc. · Chemistry device
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May 1984
Decision
50d
Days
Class 1
Risk

K841067 is an FDA 510(k) clearance for the URIC ACID REAGENT SET. Classified as Acid, Uric, Phosphotungstate Reduction (product code CDH), Class I - General Controls.

Submitted by Medical Specialties, Inc. (Mchenry, US). The FDA issued a Cleared decision on May 1, 1984 after a review of 50 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 Medical Specialties, Inc. devices

FDA 510(k) Submission Details - K841067

510(k) Number K841067 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 12, 1984
Decision Date May 01, 1984
Days to Decision 50 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
38d faster than avg
Panel avg: 88d · This submission: 50d
Pathway characteristics
Predicate-based equivalence.

CDH Device Classification - Class 1, General Controls

Product Code CDH Acid, Uric, Phosphotungstate Reduction
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 - CDH Acid, Uric, Phosphotungstate Reduction

All 12
Devices cleared under the same product code (CDH) and FDA review panel - the closest regulatory comparables to K841067.
URIC ACID REAGENT SET
K821213 · Omega Medical Electronics · Jul 1982
PHOSPHOTUNGSTATE REDUCTION, URIC ACID
K813076 · American Monitor Corp. · Nov 1981
URIC ACID (TPTZ) COLORINMETRIC
K810088 · Bio-Analytics Laboratories, Inc. · Jan 1981
SMAC REPLACEMENT REAGENTS/DETERM-URIC-AC
K800672 · Diagnostic Solutions, Inc. · May 1980
STANBIO DIRECT URIC ACID TEST SET #0770
K800190 · Stanbio Laboratory · Feb 1980
ELVI URIC ACID-COLORIMETRIC METHOD
K792403 · Volu Sol Medical Industries · Dec 1979