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Regulatory Clearances

The PreVu® Non-Invasive Skin Cholesterol Point of Care (POC) Test has been registered and/or received clearance for sale and distribution in a number of regulatory jurisdictions:

Canada

Health Canada
Therapeutic Products Directorate
Medical Devices Bureau
Licence Number: 88163
First Issue Date: 2012/01/31

This Device Class 2 License has been issued in accordance with the Medical Devices Regulations, Section 36. The PreVu Non-Invasive Skin Cholesterol Point of Care (POC) Test can be marketed in Canada for coronary artery disease risk assessment screening for use within the general population.

United States

Food and Drug Administration
Center for Devices and Radiological Health
Office of In Vitro Diagnostic Device Evaluation and Safety
Division of Chemistry and Toxicology Devices
FDA 510(k): K062092
Trade/Device Name: PreVu Point of Care (POC) Skin Sterol System
Regulation Number: 21 CFR 862.1475
Regulation Name: Lipoprotein Test System
Regulatory Class: Class I, subject to 21 CFR 862.9(c)(4)
Product Code: LBS
Dated: 2006/08/18

Indications For Use:
Skin cholesterol as measured by the PreVu Non-Invasive Skin Cholesterol Point of Care (POC) Test can be used as part of risk assessment for coronary heart disease in persons with a history of myocardial infarction and/or in persons suspected of having significant multi-vessel coronary artery disease (>50% stenosis in >1 vessel as diagnosed by coronary angiography) where further diagnostic evaluation is being considered. Test results, when considered in conjunction with clinical evaluation, blood cholesterol tests and other risk factors identified for coronary artery disease, will aid the physician in focusing diagnostic and patient management options.

European Union

Dutch Health Care Inspectorate (IGZ)
EC Rep: Emergo Europe
Molenstraat 15
2513 BH The Hague
The Netherlands
Official Registration: January 25, 2012

The Competent Authority of The Netherlands has been notified. With this notification the PreVu Non-Invasive Skin Cholesterol Point of Care (POC) Test has met the provision of the Council Directive 98/79/EC for In Vitro Diagnostic Medical Devices. It has been CE Marked and is officially registered with various Member States within the European Union. CE Marking allows the PreVu POC test to be marketed in the European Union for coronary artery disease risk assessment screening for use within the general population.