Cleared Special

K063591 - VITROS CHEMISTRY PRODUCTS CREA SLIDES,MODEL# 6802584, VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 1,MODEL#1882208

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

K063591 · Ortho-Clinical Diagnostics, Inc. · Chemistry device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
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.

FDA 510(k) Submission Details - K063591

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
75d faster than avg
Panel avg: 89d · This submission: 14d
Pathway characteristics
Modification to existing cleared device.

JFY Device Classification - Class 2, Special Controls

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 48
Devices cleared under the same product code (JFY) and FDA review panel - the closest regulatory comparables to K063591.
DIAZYME CREATININE LIQUID REAGENTS ASSAY
K062105 · Diazyme Laboratories · Apr 2007
THERMO ELECTRON ENZYMATIC CREATININE, MODEL TR35401
K061412 · Thermo-Electron Corp. · Mar 2007
WAKO L-TYPE CREATININE-M TEST, AND WAKO CREATININE CALIBRATOR
K061775 · Wako Chemicals USA, Inc. · Feb 2007
POLY-CHEM CREATININE
K061944 · Polymedco, Inc. · Nov 2006
CREATININE LIQUICOLOR
K050283 · Stanbio Laboratory · Jun 2005
IRMA SL BLOOD ANALYSIS SYSTEM CR CARTRIDGE
K030035 · Diametrics Medical, Inc. · Jun 2003
K063591 · VITROS CHEMISTRY PRODUCTS CREA SLIDES,MODEL# 6802584, VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 1,MODEL#1882208
Download PDF FDA Summary Ortho-Clinical Diagno…