Cleared Traditional

K831983 - DATA-ZYME URIC ACID PROCEDURE

K831983 is the FDA 510(k) clearance for DATA-ZYME URIC ACID PROCEDURE by Data Medical Associates, Inc.. It is a Class 1 Chemistry device (product code KNK) cleared through the Traditional 510(k) pathway after a 49-day FDA review.

K831983 · Data Medical Associates, Inc. · Chemistry device

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Aug 1983

Decision

49d

Days

Class 1

Risk

K831983 is an FDA 510(k) clearance for the DATA-ZYME URIC ACID PROCEDURE. Classified as Acid, Uric, Uricase (colorimetric) (product code KNK), Class I - General Controls.

Submitted by Data Medical Associates, Inc. (Mchenry, US). The FDA issued a Cleared decision on August 8, 1983 after a review of 49 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 Data Medical Associates, Inc. devices

Submission Details

510(k) Number	K831983 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	June 20, 1983
Decision Date	August 08, 1983
Days to Decision	49 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

39d faster than avg

Panel avg: 88d · This submission: 49d

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 79

Devices cleared under the same product code (KNK) and FDA review panel - the closest regulatory comparables to K831983.

TDX REA URIC ACID

K841702 · Abbott Laboratories · May 1984

URIC ACID REAGENT SET ENZYMATIC

K841049 · Medical Specialties, Inc. · May 1984

URIC ACID REAGENT

K840781 · American Dade · Apr 1984

URIC-ACID TEST ENZYMATIC COLORIMETRIC

K831864 · Stanbio Laboratory · Jul 1983

BECKMAN URIC ACID REAGENT

K821812 · Beckman Instruments, Inc. · Jul 1982

URIC-ACID

K813511 · Medical Analysis Systems, Inc. · Dec 1981

Related FDA 510(k) Regulatory Insights

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.

Manufacturer of K831983

Data Medical Associates, Inc.

Mchenry, IL · US

Regulatory profile

111 submissions 111 cleared

100% clearance rate · Active in Chemistry

Data Intelligence Layer

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Classification enrichment, manufacturer tracking and cross-device links are added to support regulatory research and predicate analysis workflows.

Sourced from FDA 510(k) public files . Updated monthly.

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