![]() ![]() 3 patients had glucose test levels >600 mg/dL on the Inform II, confirmed on the Vista analyzer.Among the 353 patient test results produced by the two methods: ![]() No individual result exceeded a difference of ☒0%. ![]() To show that such meters are sufficiently accurate to be used safely by healthcare professionals, the lab should demonstrate that 99% of all values are within ☑0% of the reference method for glucose concentrations >70 mg/dL, and within ☗ mg/dL for glucose concentrations 70 mg/dL, or ☑5 mg/dL for samples 70 mg/dL, 92% were within ☑0% of the Vista glucose result. In its communications, the Department of Health provided labs with guidance for investigating the safety of their blood glucose meters. Until such requirements have been met, the department’s letter advised, “the use of glucose meters in health fairs, other community screening events, and/or critical care settings must be discontinued.” In turn, the laboratory is required to fully establish (ie, validate) the analytic and clinical performance specifications of all such devices for any change of intended use in their patient population. In such a situation, noted the department, the glucose meter defaults to a high-complexity categorization under the terms of the Clinical Laboratory Improvement Amendments of 1988 (CLIA). The intended use statements found in the package inserts or manuals of many such products do not include the monitoring of glycemic control for non-diabetic patients in hospitals, or use on critically ill patients.Īs clarified in a frequently asked questions document issued on February 18, the purpose of the Department of Health’s letter was to “inform facilities on the policies and requirements surrounding off-label use of these devices.” Specifically, laboratories that use glucose meters for purposes or populations beyond the approved intended use are considered to be engaging in off-label use. In the past, however, manufacturers’ validation data has not been sufficient for FDA to extend this approved intended use to other patient populations or settings. The department’s letter followed by just a few days the issuance of two FDA guidance documents in which the agency established new premarket submission requirements for blood glucose monitors.įDA has long approved glucose meters for the measurement of whole blood glucose, and for use by healthcare professionals as an aid in monitoring the effectiveness of a diabetes control program. By also using AC current, the Accu-Chek Inform II test strips and system can gather and analyze significantly more information than other glucose meters on the market.On January 13, 2014, the New York State Department of Health sent to its licensed New York laboratories a “Dear Laboratory Director” letter regarding off-label use of glucose meters. Other blood glucose meters only use DC current, which provides the basic blood glucose measurement.
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