Cleared Special

K073157 - VITROS CHEMISTRY PRODUCTS K+ SLIDES AND CALIBRATOR KIT 2

K073157 is an FDA 510(k) clearance for VITROS CHEMISTRY PRODUCTS K+ SLIDES AND..., manufactured by Ortho-Clinical Diagnostics, Inc.. The device is a Class 2 Chemistry device with product code CEM cleared through the Special 510(k) pathway after a 29-day FDA review.

K073157 · 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 2007
Decision
29d
Days
Class 2
Risk

K073157 is an FDA 510(k) clearance for the VITROS CHEMISTRY PRODUCTS K+ SLIDES AND CALIBRATOR KIT 2. Classified as Electrode, Ion Specific, Potassium (product code CEM), Class II - Special Controls.

Submitted by Ortho-Clinical Diagnostics, Inc. (Rochester, US). The FDA issued a Cleared decision on December 7, 2007 after a review of 29 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1600 - 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 - K073157

510(k) Number K073157 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 08, 2007
Decision Date December 07, 2007
Days to Decision 29 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
60d faster than avg
Panel avg: 89d · This submission: 29d
Pathway characteristics
Modification to existing cleared device.

CEM Device Classification - Class 2, Special Controls

Product Code CEM Electrode, Ion Specific, Potassium
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1600
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 - CEM Electrode, Ion Specific, Potassium

All 87
Devices cleared under the same product code (CEM) and FDA review panel - the closest regulatory comparables to K073157.
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K073157 · VITROS CHEMISTRY PRODUCTS K+ SLIDES AND CALIBRATOR KIT 2
Download PDF FDA Summary Ortho-Clinical Diagno…