Cleared Special

K062236 - DIMENSION VISTA CYCLOSPORINE (CSA) FLEX REAGENT CARTRIDGE

K062236 is an FDA 510(k) clearance for DIMENSION VISTA CYCLOSPORINE (CSA) FLEX..., manufactured by Dade Behring, Inc.. The device is a Class 2 Chemistry device with product code MKW cleared through the Special 510(k) pathway after a 19-day FDA review.

K062236 · Dade Behring, Inc. · Chemistry device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Aug 2006
Decision
19d
Days
Class 2
Risk

K062236 is an FDA 510(k) clearance for the DIMENSION VISTA CYCLOSPORINE (CSA) FLEX REAGENT CARTRIDGE. Classified as Cyclosporine (product code MKW), Class II - Special Controls.

Submitted by Dade Behring, Inc. (Newark, US). The FDA issued a Cleared decision on August 21, 2006 after a review of 19 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1235 - 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 - K062236

510(k) Number K062236 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 02, 2006
Decision Date August 21, 2006
Days to Decision 19 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
69d faster than avg
Panel avg: 88d · This submission: 19d
Pathway characteristics
Modification to existing cleared device.

MKW Device Classification - Class 2, Special Controls

Product Code MKW Cyclosporine
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1235
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 - MKW Cyclosporine

All 8
Devices cleared under the same product code (MKW) and FDA review panel - the closest regulatory comparables to K062236.
ADVIA CENTAUR CYCLOSPORINE ASSAY AND CALIBRATOR
K071455 · Siemens Medical Solutions Diagnostics · Sep 2008
ARCHITECT CYCLOSPORINE
K080751 · Fujirebio Diagnostics,Inc. · Sep 2008
DIMENSION VISTA CSAE FLEX REGENT CARTRIDGE, MODEL K4108
K081992 · Siemens Healthcare Diagnostics, Inc. · Aug 2008
EMIT 2000 CYCLOSPORINE SPECIFIC ASSAY
K053061 · Dade Behring, Inc. · Feb 2006
CYCLOSPORINE EXTENDED RANGE ASSAY (CSAE) FLEX REAGENT CARTRIDGE, CATALOG # DF108
K052017 · Dade Behring, Inc. · Sep 2005
AXSYM CYCLOSPORINE
K040761 · Abbott Laboratories, Inc. · Apr 2004
K062236 · DIMENSION VISTA CYCLOSPORINE (CSA) FLEX REAGENT CARTRIDGE
Download PDF FDA Summary Dade Behring, Inc.