Cleared Traditional

K003247 - CREATININE

K003247 is the FDA 510(k) clearance for CREATININE by Jas Diagnostics, Inc.. It is a Class 2 Chemistry device (product code CGX) cleared through the Traditional 510(k) pathway after a 58-day FDA review.

K003247 · Jas Diagnostics, Inc. · Chemistry device
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Dec 2000
Decision
58d
Days
Class 2
Risk

K003247 is an FDA 510(k) clearance for the CREATININE. Classified as Alkaline Picrate, Colorimetry, Creatinine (product code CGX), Class II - Special Controls.

Submitted by Jas Diagnostics, Inc. (Miami, US). The FDA issued a Cleared decision on December 14, 2000 after a review of 58 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 Jas Diagnostics, Inc. devices

Submission Details

510(k) Number K003247 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 17, 2000
Decision Date December 14, 2000
Days to Decision 58 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
30d faster than avg
Panel avg: 88d · This submission: 58d
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 K003247.
SYNCHRON CX DELTA CLINICAL SYSTEMS, CREATININE TEST SYSTEMS
K071280 · Beckman Coulter, Inc. · Jun 2007
SYNCHRON SYSTEMS CREATININE REAGENT
K071283 · Beckman Coulter, Inc. · Jun 2007
SYNCHRON SYSTEMS CREATININE (CREA) REAGENT
K060935 · Beckman Coulter, Inc. · Apr 2006
VITROS CHEMISTRY PRODUCTS CREA DT SLIDES
K001769 · Ortho-Clinical Diagnostics · Jun 2000
CREATININE-S ASSAY, MODEL 221-30, 221-50, 221-17
K000055 · Diagnostic Chemicals , Ltd. · Feb 2000
CREA
K981799 · Abbott Laboratories · Jul 1998