EKF launches FDA CLIA-waived β-ketone and glucose POC analyzer to U.S. market

EKF Diagnostics, the worldwide in vitro diagnostics firm, pronounces a brand new addition to its Diabetes Care portfolio within the U.S.. The STAT-Website WB is a dual-use complete blood β-ketone and glucose meter for skilled use within the administration of diabetes. The brand new FDA CLIA-waived handheld analyzer reliably and effectively delivers outcomes inside simply 5-10 seconds, and can be utilized in point-of-care (POC) and Certificates of Waiver settings, corresponding to physicians’ workplaces, clinics and different non-traditional laboratory areas.

EKF Diagnostics’ STAT-Website WB β-ketone and glucose complete blood analyzer

As a twin analyte measurement system, the STAT-Website WB can quantitatively measure β-ketone (Beta-Hydroxybutyrate or BHB) from each recent capillary and venous complete blood in 10 seconds. As well as, it delivers quantitative measurements in 5 seconds for glucose in recent capillary, venous and in addition neonatal complete blood. Outcomes are reported on its clear LCD display and as much as 400 might be saved in reminiscence; these might be downloaded utilizing a easy mini USB cable.

The brand new system may be very easy and intuitive to make use of as it’s reagent free, utilizing check strips to which complete blood is added straight. These can be found both individually foil-wrapped or in a vial with a shelf lifetime of six months as soon as opened. For straightforward dealing with, the check strips are huge and a strip indication mild on the analyzer mild guides insertion.

Additional enhancing its ease-of-use, the STAT-Website WB’s strip identification system, routinely differentiates whether or not a blood glucose or β-ketone check strip has been inserted and can analyze accordingly through its auto begin perform. Simply 1 µL of complete blood is required for this evaluation and the system will detect and alert if inadequate blood is obtainable. Additionally supporting inexperienced customers, an computerized strip ejection perform ensures that cross contamination is averted.

Correct with wonderful linear vary, the STAT-Website WB has a measurement vary for β-ketone of zero.1 to eight.zero mmol/L and for blood glucose 10 to 600 mg/dL (zero.5 to 33.three mmol/L). Its huge hematocrit vary is 10 to 70% for β-ketone and 20 to 70% for blood glucose. Additional guaranteeing its accuracy, the system has auto QC identification and is calibrated utilizing the Liquicolor® Beta-Hydroxybutyrate methodology. That is utilized by nearly 1,300 hospitals within the USA to establish and monitor sufferers with diabetic ketoacidosis, amongst many different scientific functions.

The introduction of STAT-Website WB additional enhances our diabetes care product vary. EKF Diabetes Care strives to enhance affected person entry to diabetes care diagnostics by means of the availability of inexpensive, easy-to-use know-how, decreasing the price of long-term healthcare of the rising diabetic and pre-diabetic inhabitants. Having prepared and environment friendly entry to lab high quality β-ketone and glucose outcomes on the POC supplies each practitioner and affected person with the important data they should make scientific or way of life choices in seconds.”

Gavin Jones, Head of Product Administration, EKF Diagnostics

On account of its FDA CLIA-waived standing, the brand new STAT-Website WB is initially solely obtainable on the market to the U.S. market. The product is at the moment present process the CE mark course of and following this, this complete blood β-ketone and glucose meter shall be obtainable for skilled use within the administration of diabetes globally.

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