Cleared Traditional

K830447 - KINETIC CREATININE

K830447 is the FDA 510(k) clearance for KINETIC CREATININE by American Monitor Corp.. It is a Class 2 Chemistry device (product code CGX) cleared through the Traditional 510(k) pathway after a 42-day FDA review.

K830447 · American Monitor Corp. · Chemistry device
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Mar 1983
Decision
42d
Days
Class 2
Risk

K830447 is an FDA 510(k) clearance for the KINETIC CREATININE. Classified as Alkaline Picrate, Colorimetry, Creatinine (product code CGX), Class II - Special Controls.

Submitted by American Monitor Corp. (Mchenry, US). The FDA issued a Cleared decision on March 24, 1983 after a review of 42 days - a notably fast clearance 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: 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 American Monitor Corp. devices

Submission Details

510(k) Number K830447 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 10, 1983
Decision Date March 24, 1983
Days to Decision 42 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
46d faster than avg
Panel avg: 88d · This submission: 42d
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 111
Devices cleared under the same product code (CGX) and FDA review panel - the closest regulatory comparables to K830447.
CREATININE ASSAY KIT-KINETIC OR ENDPOINT
K842159 · Diagnostic Chemicals, Ltd. (Usa) · Aug 1984
RAICHEM CREATININE REAGENT
K840872 · Reagents Applications, Inc. · Apr 1984
CREATININE REAGENT SET
K832439 · Amresco, Inc. · Jan 1984
FLOW-PAC CREATININE REAGENT SET
K830537 · Amresco, Inc. · Mar 1983
CREATININE
K830556 · Pointe Scientific, Inc., · Mar 1983
COBAS STANDARDS FOR CREATININE
K823572 · Hoffmann-La Roche, Inc. · Jan 1983