Cleared Traditional

URIC ACID (K981766) - FDA 510(k) Clearance

Class I Chemistry device.

K981766 · Abbott Laboratories · Chemistry device

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Optimized for regulatory review, auditing and printing

Jun 1998

Decision

31d

Days

Class 1

Risk

K981766 is an FDA 510(k) clearance for the URIC ACID. Classified as Acid, Uric, Uricase (u.v.) (product code CDO), Class I - General Controls.

Submitted by Abbott Laboratories (Irving, US). The FDA issued a Cleared decision on June 19, 1998 after a review of 31 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 Abbott Laboratories devices

Submission Details

510(k) Number	K981766 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	May 19, 1998
Decision Date	June 19, 1998
Days to Decision	31 days
Submission Type	Traditional
Review Panel	Chemistry (CH)
Summary	Summary PDF
Third-party Review	No - reviewed directly by FDA
Combination Product	No
PCCP Authorized	No

Regulatory Context

Review time vs. panel average

57d faster than avg

Panel avg: 88d · This submission: 31d

Pathway characteristics

Predicate-based equivalence.

Device Classification

Product Code	CDO Acid, Uric, Uricase (u.v.)
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 - CDO Acid, Uric, Uricase (u.v.)

All 15

Devices cleared under the same product code (CDO) and FDA review panel - the closest regulatory comparables to K981766.

RANDOX URIC ACID

K033278 · Randox Laboratories, Ltd. · Feb 2004

SIGMA DIAGNOSTICS INFINITY URIC ACID REAGENT, MODELS 684-25, 684-100P, 684-500P, 684-2000P, 683-20, 683-100P

K992798 · Sigma Diagnostics, Inc. · Sep 1999

SIGMA DIAGNOSTICS INFINITY URIC ACID REAGENT KIT

K982251 · Sigma Diagnostics, Inc. · Aug 1998

URIC ACID

K981189 · Abbott Laboratories · May 1998

OLYMPUS URIC ACID REAGENT

K955752 · Olympus America, Inc. · Jan 1996

URIC ACID TEST ITEM NUMBER 65422

K932162 · Em Diagnostic Systems, Inc. · Sep 1993

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 K981766

Abbott Laboratories

Irving, TX · US

MARK LITTLEFIELD

Regulatory profile

883 submissions 868 cleared

98% clearance rate · Active in Chemistry

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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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