Cleared Traditional

K040976 - GENCHEM CREATININE REAGENT

K040976 is an FDA 510(k) clearance for GENCHEM CREATININE REAGENT, manufactured by Genchem, Inc.. The device is a Class 2 Chemistry device with product code CGX cleared through the Traditional 510(k) pathway after a 257-day FDA review.

K040976 · Genchem, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2004
Decision
257d
Days
Class 2
Risk

K040976 is an FDA 510(k) clearance for the GENCHEM CREATININE REAGENT. Classified as Alkaline Picrate, Colorimetry, Creatinine (product code CGX), Class II - Special Controls.

Submitted by Genchem, Inc. (Brea, US). The FDA issued a Cleared decision on December 27, 2004 after a review of 257 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 Genchem, Inc. devices

FDA 510(k) Submission Details - K040976

510(k) Number K040976 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 14, 2004
Decision Date December 27, 2004
Days to Decision 257 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
169d slower than avg
Panel avg: 88d · This submission: 257d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CGX Device Classification - Class 2, Special Controls

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 142
Devices cleared under the same product code (CGX) and FDA review panel - the closest regulatory comparables to K040976.
SYNCHRON SYSTEMS CREATININE REAGENT
K071283 · Beckman Coulter, Inc. · Jun 2007
SYNCHRON SYSTEMS CREATININE (CREA) REAGENT
K060935 · Beckman Coulter, Inc. · Apr 2006
SPOTCHEM II CREATININE, AMYLASE & ALP TESTS
K050652 · Arkray, Inc. · Apr 2005
CREATININE REAGENT KIT FOR BECKMAN SYNCHRON CX & CX DELTA SYSTEMS
K033058 · Diamond Diagnostics, Inc. · Jan 2004
CREATININE
K003247 · Jas Diagnostics, Inc. · Dec 2000
VITROS CHEMISTRY PRODUCTS CREA DT SLIDES
K001769 · Ortho-Clinical Diagnostics · Jun 2000