Cleared Traditional

K913706 - ABBOTT QUICKSTART URIC ACID TEST (URCA)...

K913706 is the FDA 510(k) clearance for ABBOTT QUICKSTART URIC ACID TEST (URCA)... by Em Diagnostic Systems, Inc.. It is a Class 1 Chemistry device (product code KNK) cleared through the Traditional 510(k) pathway after a 39-day FDA review.

K913706 · Em Diagnostic Systems, Inc. · Chemistry device
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Sep 1991
Decision
39d
Days
Class 1
Risk

K913706 is an FDA 510(k) clearance for the ABBOTT QUICKSTART URIC ACID TEST (URCA) ITEM# 5A34. Classified as Acid, Uric, Uricase (colorimetric) (product code KNK), Class I - General Controls.

Submitted by Em Diagnostic Systems, Inc. (Gibbstown, US). The FDA issued a Cleared decision on September 27, 1991 after a review of 39 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 Em Diagnostic Systems, Inc. devices

Submission Details

510(k) Number K913706 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 19, 1991
Decision Date September 27, 1991
Days to Decision 39 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
49d faster than avg
Panel avg: 88d · This submission: 39d
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 78
Devices cleared under the same product code (KNK) and FDA review panel - the closest regulatory comparables to K913706.
MILES AUTO METH DETERMIN OF URIC ACID IN URINE
K924129 · Heraeus Kulzer, Inc. · Sep 1992
OLYMPUS URIC ACID REAGENT
K922756 · Olympus Corp. · Jul 1992
ROCHE REAGENT FOR URIC ACID--MODIFICATION
K922762 · Roche Diagnostic Systems, Inc. · Jul 1992
SYNERMED URIC ACID REAGENT KIT
K903727 · Synermed, Inc. · Sep 1990
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