Accreditations

Patient Focus Africa (PFA) pride ourselves in the promoting and selling of approved POINT OF CARE TECHNOLOGY that carries with it the following Accreditations:

*CLIA WAIVED

The Clinical Laboratory Improvement Amendments (CLIA) regulate laboratory testing and require clinical laboratories to be certificated by their state before they can accept human samples for diagnostic testing.

*FDA CLEARED

Food and Drug Administration. Cleared medical devices: These medical devices are ones that FDA has determined to be substantially equivalent to another legally marketed device. A premarket notification, referred to as a 510(k), must be submitted to FDA for clearance. A 510(k) is most often submitted by the medical device manufacturer.

*CE MARKED

CE Marking is the symbol as shown on the top of this page. The letters “CE” are the abbreviation of French phrase “Conformité Européenne” which literally means “European Conformity”. The CE mark is required for all new products which are subject to one or more of the European product safety Directives. It is a visible sign that the manufacturer of the product is declaring conformity with all the Directives relating to that product.

*MEETS NCEP GUIDELINES

The CardioChek PA and CardioChek Plus systems, properly used, produce lipid results that meet the accuracy guidelines established by the National Cholesterol Education Program (NCEP) of the National Institutes of Health (NIH). The National Institutes of Health (NIH), through its National Cholesterol Education Program (NCEP), has established test protocols and guidelines for acceptable deviation from “truth,” or the NRS/Chol (the National Reference System for Cholesterol) reference value. These guidelines state that Total Analytical Error (TAE) should be within the following limits from reference when these test protocols are followed.

*CRMLN CERTIFIED Cholesterol Reference Method Laboratory Network

The Cholesterol Reference Method Laboratory Network (CRMLN) certifies manufacturers of clinical diagnostic products that measure total cholesterol, HDL-C, and LDL-C. The CRMLN laboratories use reference methods or designated comparison methods that are rigorously standardized to the CDC reference methods.

*NGSP CERTIFIED – National Glycohemoglobin Standardization Program

The purpose of the NGSP is to standardize glycated haemoglobin test results so that A1c results are comparable to those reported in the Diabetes Control and Complications Trial (DCCT) where relationships to mean blood glucose and risk for vascular complications have been established. To achieve NGSP certification, an A1c testing method must successfully complete rigorous testing requirements annually. A key component of the certification process is the Reference Laboratory Network. The network interacts with manufacturers of glycohemoglobin methods to assist them first in standardizing their methods and then in providing comparison data for certification of traceability to the DCCT. A1c test methods are awarded a ‘certificate of traceability to the DCCT reference method’ if they pass rigorous accuracy-testing criteria.

*CLIA Waived – The Clinical Laboratory Improvement Amendments (CLIA)

regulate laboratory testing and require clinical laboratories to be certificated by their state before they can accept human samples for diagnostic testing.

*CE Marked

The letters “CE” are the abbreviation of French phrase “Conformité Européenne” which literally means “European Conformity”. The CE mark is required for all new products which are subject to one or more of the European product safety Directives. It is a visible sign that the manufacturer of the product is declaring conformity with all the Directives relating to that product.

*IFCC Traceable – International Federation of Clinical Chemistry

The relationship between the National Glycohemoglobin Standardization Program (NGSP) A1c calibration (expressed as % A1c) and the International Federation of Clinical Chemistry (IFCC) network calibration (expressed as mmol/mol) has been shown to be stable and is given by the master equation: (NGSP = [0.09148 * IFCC] + 2.152). The A1CNow+ system is NGSP certified (DCCT-traceable) and results can be converted to IFCC units with the master equation. Demonstrating IFCC traceability is a formal process during which A1c blood samples are assigned values by the IFCC network. Manufacturers use these samples to verify alignment of their assay with the IFCC network. The A1CNow+ system  is now IFCC-traceable, while continuing to maintain NGSP certification (DCCT-traceable).

*NGSP CERTIFIED – National Glycohemoglobin Standardization Program

The purpose of the NGSP is to standardize glycated haemoglobin test results so that A1c results are comparable to those reported in the Diabetes Control and Complications Trial (DCCT) where relationships to mean blood glucose and risk for vascular complications have been established. To achieve NGSP certification, an A1c testing method must successfully complete rigorous testing requirements annually. A key component of the certification process is the Reference Laboratory Network. The network interacts with manufacturers of glycohemoglobin methods to assist them first in standardizing their methods and then in providing comparison data for certification of traceability to the DCCT. A1c test methods are awarded a ‘certificate of traceability to the DCCT reference method’ if they pass rigorous accuracy-testing criteria.

*CLIA Waived – The Clinical Laboratory Improvement Amendments (CLIA)

regulate laboratory testing and require clinical laboratories to be certificated by their state before they can accept human samples for diagnostic testing.

*CE Marked

The letters “CE” are the abbreviation of French phrase “Conformité Européenne” which literally means “European Conformity”. The CE mark is required for all new products which are subject to one or more of the European product safety Directives. It is a visible sign that the manufacturer of the product is declaring conformity with all the Directives relating to that product.

*IFCC Traceable – International Federation of Clinical Chemistry

The relationship between the National Glycohemoglobin Standardization Program (NGSP) A1c calibration (expressed as % A1c) and the International Federation of Clinical Chemistry (IFCC) network calibration (expressed as mmol/mol) has been shown to be stable and is given by the master equation: (NGSP = [0.09148 * IFCC] + 2.152). The A1CNow+ system is NGSP certified (DCCT-traceable) and results can be converted to IFCC units with the master equation. Demonstrating IFCC traceability is a formal process during which A1c blood samples are assigned values by the IFCC network. Manufacturers use these samples to verify alignment of their assay with the IFCC network. The A1CNow+ system  is now IFCC-traceable, while continuing to maintain NGSP certification (DCCT-traceable).

*ISO ACCREDITED – International Organization for Standardization

ISO 15197:2003 In vitro diagnostic test systems — Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus. ISO 15197:2003 specifies requirements for in vitro glucose monitoring systems that measure glucose concentrations in capillary blood samples and procedures for the verification and the validation of performance by the intended users. These systems are intended for self-testing by laypersons for management of diabetes mellitus.

*FDA CLEARED – Food and Drug Administration Cleared medical devices:

These medical devices are ones that FDA has determined to be substantially equivalent to another legally marketed device. A premarket notification, referred to as a 510(k), must be submitted to FDA for clearance. A 510(k) is most often submitted by the medical device manufacturer.

*CE Marked

CE Marking is the symbol as shown on the top of this page. The letters “CE” are the abbreviation of French phrase “Conformité Européenne” which literally means “European Conformity”. The CE mark is required for all new products which are subject to one or more of the European product safety Directives. It is a visible sign that the manufacturer of the product is declaring conformity with all the Directives relating to that product.

*BHS A/A

British Hypertension Society A rating for Systolic & A rating for Diastolic.

*ESH PASS

The main purpose of the European Society of Hypertension (ESH) is to provide a stable and organised European platform for scientific exchange in hypertension.

*GERMAN HYPERTENSION SOCIETY PASS

It is the aim of the German Hypertension Society to improve measurement accuracy, by testing and awarding Blood Pressure Monitoring devices that fulfil its own test criteria following the strict protocol of the German Hypertension Society

*CE Marked

CE Marking is the symbol as shown on the top of this page. The letters “CE” are the abbreviation of French phrase “Conformité Européenne” which literally means “European Conformity”. The CE mark is required for all new products which are subject to one or more of the European product safety Directives. It is a visible sign that the manufacturer of the product is declaring conformity with all the Directives relating to that product.

*BHS A/A

British Hypertension Society A rating for Systolic & A rating for Diastolic.

*ESH PASS

The main purpose of the European Society of Hypertension (ESH) is to provide a stable and organised European platform for scientific exchange in hypertension.

*ISO ACCREDITED – International Organization for Standardization

EN ISO 13485:2012 + AC:2012

Medical devices – Quality management systems -Requirements for regulatory purposes

(ISO 13485:2003 + Cor. 1 :2009)

DIN EN ISO 13485:2012

*MDD Conformity 93/42/EEC Medical devices

CE marking to the Medical Device Directive, 93/42/EEC is important if you manufacture or distribute medical devices within the European Economic Area.

The directive covers all products which claim to have a medical purpose and which are used in, and on, the human body, from heart valves to scalpels, excluding in vitro diagnostics, which are covered in a separate directive.

The exact definition of which products are covered can be found in the directive. However guidance on classification of your devices and which assessment route is most appropriate to meet your business needs is available directly from the LRQA Medical Device team.

Devices covered by the Medical Device Directive are grouped into four classes, according to the level of risk they present. The classification determines the choice of conformity assessment available to you.

• Class I – Low risk
• Class IIa – Medium – low risk
• Class IIb – Medium – high risk
• Class III – High risk

*CE Marked

CE Marking is the symbol as shown on the top of this page. The letters “CE” are the abbreviation of French phrase “Conformité Européenne” which literally means “European Conformity”. The CE mark is required for all new products which are subject to one or more of the European product safety Directives. It is a visible sign that the manufacturer of the product is declaring conformity with all the Directives relating to that product.

*ROHS COMPLIANCE

RoHS stands for Restriction of Hazardous Substances, and impacts the entire electronics industry and many electrical products as well. The original RoHS, also known as Directive 2002/95/EC, originated in the European Union in 2002 and restricts the use of six hazardous materials found in electrical and electronic products. All applicable products in the EU market since July 1, 2006 must pass RoHS compliance.

*CLINICALLY TESTED IN EUROPE TO BE ACCURATE

*CE Marked

CE Marking is the symbol as shown on the top of this page. The letters “CE” are the abbreviation of French phrase “Conformité Européenne” which literally means “European Conformity”. The CE mark is required for all new products which are subject to one or more of the European product safety Directives. It is a visible sign that the manufacturer of the product is declaring conformity with all the Directives relating to that product.

*Devices comply with the requirements of the Medical Device Directive 93/42/EEC.

*CE Marked

CE Marking is the symbol as shown on the top of this page. The letters “CE” are the abbreviation of French phrase “Conformité Européenne” which literally means “European Conformity”. The CE mark is required for all new products which are subject to one or more of the European product safety Directives. It is a visible sign that the manufacturer of the product is declaring conformity with all the Directives relating to that product.

*CE Marked

CE Marking is the symbol as shown on the top of this page. The letters “CE” are the abbreviation of French phrase “Conformité Européenne” which literally means “European Conformity”. The CE mark is required for all new products which are subject to one or more of the European product safety Directives. It is a visible sign that the manufacturer of the product is declaring conformity with all the Directives relating to that product.

*CE Marked

CE Marking is the symbol as shown on the top of this page. The letters “CE” are the abbreviation of French phrase “Conformité Européenne” which literally means “European Conformity”. The CE mark is required for all new products which are subject to one or more of the European product safety Directives. It is a visible sign that the manufacturer of the product is declaring conformity with all the Directives relating to that product.

*FDA CLEARED – Food and Drug Administration Cleared medical devices:

These medical devices are ones that FDA has determined to be substantially equivalent to another legally marketed device. A premarket notification, referred to as a 510(k), must be submitted to FDA for clearance. A 510(k) is most often submitted by the medical device manufacturer.

*ISO ACCREDITED – International Organization for Standardization

EN ISO 13485:2012 + AC:2012

Medical devices – Quality management systems -Requirements for regulatory purposes

(ISO 13485:2003 + Cor. 1 :2009)

DIN EN ISO 13485:2012

*FDA CLEARED

Food and Drug Administration. Cleared medical devices: These medical devices are ones that FDA has determined to be substantially equivalent to another legally marketed device. A premarket notification, referred to as a 510(k), must be submitted to FDA for clearance. A 510(k) is most often submitted by the medical device manufacturer.

*ISO ACCREDITED

EN ISO10993-1/-5/-10, IEC 60601-1, EN 60601-1-2, EN ISO9919, EN 62304, EN60601-1-6