Cleared Traditional

K023407 - ATAC PAK CREATININE REAGENT AND ATAC CALIBRATOR

K023407 is an FDA 510(k) clearance for ATAC PAK CREATININE REAGENT AND ATAC CA..., manufactured by Elan Diagnostics. The device is a Class 2 Chemistry device with product code CGX cleared through the Traditional 510(k) pathway after a 127-day FDA review.

K023407 · Elan Diagnostics · Chemistry device
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Optimized for regulatory review, auditing and printing
Feb 2003
Decision
127d
Days
Class 2
Risk

K023407 is an FDA 510(k) clearance for the ATAC PAK CREATININE REAGENT AND ATAC CALIBRATOR. Classified as Alkaline Picrate, Colorimetry, Creatinine (product code CGX), Class II - Special Controls.

Submitted by Elan Diagnostics (Brea, US). The FDA issued a Cleared decision on February 14, 2003 after a review of 127 days - within the typical 510(k) review window.

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.

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FDA 510(k) Submission Details - K023407

510(k) Number K023407 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 10, 2002
Decision Date February 14, 2003
Days to Decision 127 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
39d slower than avg
Panel avg: 88d · This submission: 127d
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 143
Devices cleared under the same product code (CGX) and FDA review panel - the closest regulatory comparables to K023407.
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
CREATININE-S ASSAY, MODEL 221-30, 221-50, 221-17
K000055 · Diagnostic Chemicals , Ltd. · Feb 2000