Cleared Traditional

CREATININE REAGENT SET (K832439) - FDA 510(k) Clearance

Class II Chemistry device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K832439 · Amresco, Inc. · Chemistry device
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Jan 1984
Decision
176d
Days
Class 2
Risk

K832439 is an FDA 510(k) clearance for the CREATININE REAGENT SET. Classified as Alkaline Picrate, Colorimetry, Creatinine (product code CGX), Class II - Special Controls.

Submitted by Amresco, Inc. (Mchenry, US). The FDA issued a Cleared decision on January 17, 1984 after a review of 176 days - an extended review cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1225 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all Amresco, Inc. devices

Submission Details

510(k) Number K832439 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 25, 1983
Decision Date January 17, 1984
Days to Decision 176 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
88d slower than avg
Panel avg: 88d · This submission: 176d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code CGX Alkaline Picrate, Colorimetry, Creatinine
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1225
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Chemistry devices follow this clearance model.

Regulatory Peers - CGX Alkaline Picrate, Colorimetry, Creatinine

All 39
Devices cleared under the same product code (CGX) and FDA review panel - the closest regulatory comparables to K832439.
VISION CREATININE
K854846 · Abbott Laboratories · Jan 1986
TDX REA CREATININE
K843916 · Abbott Laboratories · Oct 1984
SYSTEMATE CREATININE 67223
K843105 · Em Diagnostic Systems, Inc. · Aug 1984
LANCER CREATININE MICROSAMPLE STAT ANA
K803087 · Sherwood Medical Co. · Jan 1981
PROCEDURE NO. 555
K771916 · Sigma Chemical Co. · Oct 1977
MULTISTAT III CREATININE TEST
K771443 · Instrumentation Laboratory CO · Aug 1977