Cleared Traditional

K070383 - ENZYMATIC CREATININE ASSAY (265 SERIES)

K070383 is the FDA 510(k) clearance for ENZYMATIC CREATININE ASSAY (265 SERIES) by Diagnostic Chemicals , Ltd.. It is a Class 2 Chemistry device (product code JFY) cleared through the Traditional 510(k) pathway after a 133-day FDA review.

K070383 · Diagnostic Chemicals , Ltd. · Chemistry device
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Jun 2007
Decision
133d
Days
Class 2
Risk

K070383 is an FDA 510(k) clearance for the ENZYMATIC CREATININE ASSAY (265 SERIES). Classified as Enzymatic Method, Creatinine (product code JFY), Class II - Special Controls.

Submitted by Diagnostic Chemicals , Ltd. (Charlottetown, P.E., CA). The FDA issued a Cleared decision on June 22, 2007 after a review of 133 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.

View all Diagnostic Chemicals , Ltd. devices

Submission Details

510(k) Number K070383 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 09, 2007
Decision Date June 22, 2007
Days to Decision 133 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
45d slower than avg
Panel avg: 88d · This submission: 133d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JFY Enzymatic Method, 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 - JFY Enzymatic Method, Creatinine

All 30
Devices cleared under the same product code (JFY) and FDA review panel - the closest regulatory comparables to K070383.
SYNCHRON SYSTEMS ENZYMATIC CREATININE (CR-E) REAGENT, MODEL A60298
K091742 · Beckman Coulter, Inc. · Aug 2009
DIMENSION VISTA ENZYMATIC CREATININE FLEX REAGENT CARTRIDGE, AND ENZYMATIC CREATININE CALIBRATOR, MODELS K1270, KC270
K090330 · Siemens Healthcare Diagnostics, Inc. · May 2009
DIMENSION ENZYMATIC CREATININE FLEX REAGENT CARTRIDGE WITH MODEL DF270
K073055 · Dade Behring, Inc. · Jan 2008
VITROS CHEMISTRY PRODUCTS URCR SLIDES, VITROS CHEMISTRY PRODUCTS DT CALIBRATOR KIT, MODEL 680 2722, 195 7927
K071215 · Ortho-Clinical Diagnostics, Inc. · May 2007
VITROS CHEMISTRY PRODUCTS CRSC SLIDES, VITROS CHEMISTRY PRODUCTS DT CALIBRATOR KIT, MODEL 680 2721, 195 7927
K071216 · Ortho-Clinical Diagnostics, Inc. · May 2007
DIAZYME CREATININE LIQUID REAGENTS ASSAY
K062105 · Diazyme Laboratories · Apr 2007