Cleared Special

K063591 - VITROS CHEMISTRY PRODUCTS CREA SLIDES

K063591 is the FDA 510(k) clearance for VITROS CHEMISTRY PRODUCTS CREA SLIDES by Ortho-Clinical Diagnostics, Inc.. It is a Class 2 Chemistry device (product code JFY) cleared through the Special 510(k) pathway after a 14-day FDA review.

K063591 · Ortho-Clinical Diagnostics, Inc. · Chemistry device
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Dec 2006
Decision
14d
Days
Class 2
Risk

K063591 is an FDA 510(k) clearance for the VITROS CHEMISTRY PRODUCTS CREA SLIDES,MODEL# 6802584, VITROS CHEMISTRY PRODUC.... Classified as Enzymatic Method, Creatinine (product code JFY), Class II - Special Controls.

Submitted by Ortho-Clinical Diagnostics, Inc. (Rochester, US). The FDA issued a Cleared decision on December 15, 2006 after a review of 14 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Ortho-Clinical Diagnostics, Inc. devices

Submission Details

510(k) Number K063591 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 01, 2006
Decision Date December 15, 2006
Days to Decision 14 days
Submission Type Special
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
74d faster than avg
Panel avg: 88d · This submission: 14d
Pathway characteristics
Modification to existing cleared device.

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 K063591.
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
WAKO L-TYPE CREATININE-M TEST, AND WAKO CREATININE CALIBRATOR
K061775 · Wako Chemicals USA, Inc. · Feb 2007
CREATININE LIQUICOLOR
K050283 · Stanbio Laboratory · Jun 2005
COBAS INTEGRA CREATININE PLUS VER.2 ASSAY
K024098 · Roche Diagnostics Corp. · Dec 2002
CLINITEK ATLAS PRO 12 REAGENT PAK SYSTEM
K021428 · Bayer Corp. · Jul 2002