Cleared Traditional

ABBOTT SPECTRUM URIC ACID REAGENT KIT (K896954) - FDA 510(k) Clearance

Class I Chemistry device.

K896954 · Abbott Laboratories · Chemistry device
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Feb 1990
Decision
71d
Days
Class 1
Risk

K896954 is an FDA 510(k) clearance for the ABBOTT SPECTRUM URIC ACID REAGENT KIT. Classified as Acid, Uric, Uricase (colorimetric) (product code KNK), Class I - General Controls.

Submitted by Abbott Laboratories (Abbott Park, US). The FDA issued a Cleared decision on February 23, 1990 after a review of 71 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 K896954 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 14, 1989
Decision Date February 23, 1990
Days to Decision 71 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
17d faster than avg
Panel avg: 88d · This submission: 71d
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 45
Devices cleared under the same product code (KNK) and FDA review panel - the closest regulatory comparables to K896954.
COBAS READY PROFILE 2 REAGENT STRIP
K896225 · Roche Diagnostic Systems, Inc. · Jun 1990
WAKO(TM) AUTOKIT URIC ACID
K901544 · Wako Chemicals USA, Inc. · May 1990
TECHNICON CHEM 1 CLINICAL ANALYZER FOR URINE URIC
K901693 · Technicon Instruments Corp. · Apr 1990
COBAS READY URIC ACID REAGENT
K896227 · Roche Diagnostic Systems, Inc. · Feb 1990
MODIFIED PARAMAX URIC ACID REAGENT
K896521 · Baxter Healthcare Corp · Feb 1990
URIC ACID PAP
K895665 · Boehringer Mannheim Corp. · Oct 1989