Cleared Special

K082099 - VITROS CHEMISTRY PRODUCTS CI-DT SLIDES

Also marketed or referenced as:
VITROS CHEMISTRY PRODUCTS DT CALIBRATOR KIT, MODELS CI-DT SLIDES:131 4905

K082099 is an FDA 510(k) clearance for VITROS CHEMISTRY PRODUCTS CI-DT SLIDES, manufactured by Ortho-Clinical Diagnostics, Inc.. The device is a Class 2 Chemistry device with product code CGZ cleared through the Special 510(k) pathway after a 27-day FDA review.

K082099 · Ortho-Clinical Diagnostics, Inc. · Chemistry device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Aug 2008
Decision
27d
Days
Class 2
Risk

K082099 is an FDA 510(k) clearance for the VITROS CHEMISTRY PRODUCTS CI-DT SLIDES. Classified as Electrode, Ion-specific, Chloride (product code CGZ), Class II - Special Controls.

Submitted by Ortho-Clinical Diagnostics, Inc. (Rochester, US). The FDA issued a Cleared decision on August 21, 2008 after a review of 27 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1170 - 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 - K082099

510(k) Number K082099 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 25, 2008
Decision Date August 21, 2008
Days to Decision 27 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
62d faster than avg
Panel avg: 89d · This submission: 27d
Pathway characteristics
Modification to existing cleared device.

CGZ Device Classification - Class 2, Special Controls

Product Code CGZ Electrode, Ion-specific, Chloride
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1170
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 - CGZ Electrode, Ion-specific, Chloride

All 37
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K082099 · VITROS CHEMISTRY PRODUCTS CI-DT SLIDES
Download PDF FDA Summary Ortho-Clinical Diagno…