FDA Perspective: FDA Evaluation of Point of Care Blood Glucose Meters

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FDA Perspective: FDA Evaluation of Point of Care Blood Glucose Meters Patricia Bernhardt, M.T.(ASCP) , Scientific Reviewer Office of in Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

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FDA Regulation of Medical Devices Federal Food, Drug, and Cosmetic Act (The Act) Medical Device Amendments of May 28, 1976 Risk based control by expected utilize Class I - generally safe, normally excluded from Premarket audit Class II - direct hazard, requires "generous identicalness" to predicate gadget (510(k) freedom) Class III – high hazard and novel planned uses, require premarket endorsement (PMA)

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What is an IVD? "Reagents, instruments, and frameworks expected for use in the conclusion of ailment or different conditions, including an assurance of the condition of wellbeing, keeping in mind the end goal to cure, relieve, treat, or avert sickness or its sequelae in man.… for use in the gathering, readiness, and examination of examples from the human body." [21 CFR 809.3] Used in clinical research centers Other settings (e.g., Point-of-Care/Over-the-Counter) FDA directs IVDs by the proposed utilize and danger of off base result All IVDs must build up sufficient scientific and clinical execution Labeling (21 CFR 809.10)

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FDA Evaluation of POC BGMS Class II gadget (direct hazard) Requires 510(k) generous identicalness to predicate FDA assesses planned utilize, execution, naming

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FDA Evaluation of POC BGMS Intended utilize - Quantitative estimation of glucose in entire blood by lay clients at home or by medicinal services experts in clinical settings to help with the progressing assessment and administration of people with diabetes For checking Not for analysis or screening Currently no qualification between execution prerequisites for OTC and expert utilize

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FDA Evaluation of POC BGMS System segments Meter Test strips Quality control arrangements Sometimes spearing gadgets, lancets and liquor wipes Each meter and test strip when utilized together is a "framework", requiring separate execution testing of that "framework", paying little mind to earlier administrative status of individual segments

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FDA Evaluation of POC BGMS Each specimen sort requires FDA survey and freedom Typically slender entire blood from fingersticks Some utilization blood vessel, venous, or neonatal Alternative locales (AST, for example, lower arm, upper arm, palm, thigh, calf

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FDA Evaluation of POC BGMS FDA Guidances Total Product Life Cycle for Portable Invasive Blood Glucose Monitoring Systems (1997) Points to Consider for Portable Blood Glucose observing Devices Intended for Bedside Use in the Neonate Nursery (1996) Guidance for Content of Pre Market Submissions for Software Contained in Medical Devices International Standards Organization (ISO) standard ISO 15197, In vitro analytic test systems -Requirements for blood-glucose checking frameworks for self-testing in overseeing diabetes mellitus (2003) Clinical Laboratory Standards Institute (CLSI) guidelines

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FDA Evaluation of POC BGMS Factors for assessing BGMS execution Precision Accuracy Linearity Interferences Environmental Software Labeling

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BGMS Performance Precision Repeatability assess focuses spread crosswise over measuring range (e.g. 30-50, 51-110, 111-150, 151-250, 251-400 mg/dL) numerous meters, one day mean, SD, CV for every meter Intermediate different meters, various days, numerous strip parcels ordinarily control arrangements

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BGMS Performance Method Comparison to perceived reference technique, (for example, YSI) all around approved for exactness and trueness traceable to a perceived glucose standard, (for example, NIST Standard Reference Material) least of 100 narrow specimens spreading over measuring range

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BGMS Performance Method correlation, proceeded with Evaluation of plots of subject gadget versus reference gadget Bias plots Regression investigations Difference plots Determine framework precision

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BGMS Performance Current FDA least satisfactory framework precision and precision in the hands of clients 95 % of individual glucose comes about might fall inside   15 mg/dL of the consequences of the reference estimation at glucose focuses < 75 mg/dL 95% of individual results should fall inside   20 % at glucose fixations > 75 mg/dL

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Format for Presentation of Accuracy Data A late assessment of glucose meters cleared in most recent 2 years demonstrated that approx. 72% would meet + 10 mg/dL at <75 mg/dL and approx. half would meet + 15% at > 75 mg/dL

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BGMS Performance User Performance Evaluate whether planned clients can work and get right results utilizing just guidelines to be given when gadget is promoted Lay clients acquire and run possess tests Compare lay client results to reference Questionnaire to survey understanding

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BGMS Performance Alternative Site Testing unfaltering state lay clients get and run claim tests each guaranteed site contrasted with narrow finger on perceived reference (YSI) meet least worthy precision criteria proper directions and constraints in naming

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BGMS Performance Other example sorts Venous and blood vessel grid consider - tests gathered in anticoagulant traverse measuring range contrast with reference Neonatal FDA direction 10-50 mg/dL glucose 45-65% hct

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BGMS Performance Linearity CLSI EP6-A numerous focuses crosswise over whole asserted measuring range various recreates line of relapse distinction plots

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BGMS Performance Interference CLSI EP-7A Common endogenous and exogenous Hemolysis Icterus Lipemia Sugars other than glucose Common OTC substances Frequently controlled diabetes drugs

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BGM Performance Interference, proceeded with Endogenous Highest levels at which may happen Exogenous Therapeutic levels and most elevated amounts at which harmful dosages may happen Samples speaking to clinical choice focuses Bias + 10% Hematocrit contrasted with typical Hct (~40%) and reference Individual inclination + 15%

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BGM Performance Other variables assessed Environmental impacts Temperature Humidity Altitude Conformance to IEC Medical Electrical Equipment gauges Electromagnetic Compatibility Software

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FDA Evaluation of POC BGMS Labeling User manual Test strip embed Quality control arrangements embed Quick Reference Guide, if applicable Box and compartment marks 21 CFR 809.10 OTC naming at 8 th grade perusing level

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Summary Many elements influence BGMS exactness linearity precision interferences matrix environment software labeling Each component as of now assessed independently User encounters total impact