Cleared Traditional

K813076 - PHOSPHOTUNGSTATE REDUCTION, URIC ACID

K813076 is an FDA 510(k) clearance for PHOSPHOTUNGSTATE REDUCTION, manufactured by American Monitor Corp.. The device is a Class 1 Chemistry device with product code CDH cleared through the Traditional 510(k) pathway after a 14-day FDA review.

K813076 · American Monitor Corp. · Chemistry device
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Nov 1981
Decision
14d
Days
Class 1
Risk

K813076 is an FDA 510(k) clearance for the PHOSPHOTUNGSTATE REDUCTION, URIC ACID. Classified as Acid, Uric, Phosphotungstate Reduction (product code CDH), Class I - General Controls.

Submitted by American Monitor Corp. (Mchenry, US). The FDA issued a Cleared decision on November 16, 1981 after a review of 14 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 American Monitor Corp. devices

FDA 510(k) Submission Details - K813076

510(k) Number K813076 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 02, 1981
Decision Date November 16, 1981
Days to Decision 14 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
74d faster than avg
Panel avg: 88d · This submission: 14d
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 K813076.
URIC ACID REAGENT SET
K841067 · Medical Specialties, Inc. · May 1984
URIC ACID REAGENT SET
K821213 · Omega Medical Electronics · Jul 1982
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