Product Code: CDH FDA class 1 21 CFR 862.1775

Acid, Uric, Phosphotungstate Reduction

Clinical Chemistry

The Phosphotungstate Reduction Uric Acid Test is a clinical chemistry device that measures uric acid concentration in blood or urine using a colorimetric reaction in which uric acid reduces phosphotungstic acid to produce a blue color proportional to the uric acid content, used in the diagnosis and monitoring of gout and hyperuricemia. It is classified as FDA Class 1 (lowest risk), subject only to general controls, and is exempt from premarket notification. The product code is CDH, regulated under 21 CFR 862.1775, within the Clinical Chemistry medical specialty. No special flags apply to this device.

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510(k)s

FEI Numbers

Registration Numbers

Unique Applicants

Years Active

Basic Information

Product Code: CDH
Device Class: FDA class 1
Regulation Number: 862.1775
Medical Specialty: Clinical Chemistry
Review Panel: CH
Submission Type: 4

Device Characteristics

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GMP Exempt

✗

Implant

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Life Sustain/Support

✗

Third Party

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Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 15 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K850933	URIC ACID	Jun 25, 1985	Substantially Equivalent	Dilab, Inc.
K841067	URIC ACID REAGENT SET	May 01, 1984	Substantially Equivalent	Medical Specialties, Inc.
K821213	URIC ACID REAGENT SET	Jul 13, 1982	Substantially Equivalent	Omega Medical Electronics
K813076	PHOSPHOTUNGSTATE REDUCTION, URIC ACID	Nov 16, 1981	Substantially Equivalent	American Monitor Corp.
K810088	URIC ACID (TPTZ) COLORINMETRIC	Jan 28, 1981	Substantially Equivalent	Bio-Analytics Laboratories, Inc.
K800672	SMAC REPLACEMENT REAGENTS/DETERM-URIC-AC	May 28, 1980	Substantially Equivalent	Diagnostic Solutions, Inc.
K800190	STANBIO DIRECT URIC ACID TEST SET #0770	Feb 13, 1980	Substantially Equivalent	Stanbio Laboratory
K792412	ELVI URIC ACID	Dec 07, 1979	Substantially Equivalent	Volu Sol Medical Industries
K792403	ELVI URIC ACID-COLORIMETRIC METHOD	Dec 07, 1979	Substantially Equivalent	Volu Sol Medical Industries
K790019	SERUM, URIC ACID DETERMINATION	Feb 26, 1979	Substantially Equivalent	Fisher Scientific Co., LLC
K772082	ENZAC URIC ACID 100-TEST KIT	Nov 28, 1977	Substantially Equivalent	Bd Becton Dickinson Vacutainer Systems Preanalytic
K771842	URIC ACID	Oct 25, 1977	Substantially Equivalent	Gamma Enterprises, Inc.
K770564	URIC ACID TEST KIT	Jun 03, 1977	Substantially Equivalent	Mallinckrodt Critical Care
K770459	URIC ACID PROCEDURE, TEKPOINT DIRECT	Apr 29, 1977	Substantially Equivalent	Icn Pharmaceuticals, Inc.
K760477	REAGENTS-4 FOR URIC ACID DETERMINATION	Oct 29, 1976	Substantially Equivalent	Simmler & Son, Inc.