EKF Secures FDA Clearance for DiaSpect Tm POC Hemoglobin Analyzer

EKF Diagnostics, the global in-vitro diagnostics company, has received U.S. Food and Drug Administration (FDA) 510(k) clearance and CLIA waiver for its hand-held, reagent-free hemoglobin analyzer, the DiaSpect Tm. The device is cleared for use in point of care (POC) and Certificate of Waiver settings, such as physicians’ offices, clinics and other non-traditional laboratory locations.
 
The DiaSpect Tm provides users with accurate hemoglobin measurements (precision: CV ≤1 percent) within two seconds of its whole blood-filled cuvette being inserted for analysis. This ensures immediate and robust hemoglobin results for patient health checks and anemia screening at the point of care.
 
Based on its FDA categorization, DiaSpect Tm can be used in a variety of settings, as well as by a wide range of health care personnel. Essential for this, it is highly user-friendly requiring minimal training. The user simply collects a capillary or venous blood sample of 10 µL in the cuvette before inserting straight into the analyzer. Also making it simple for POCT use, DiaSpect Tm is factory calibrated against the HiCN reference method in accordance with ICSH. It is “always on” and ready to use with no re-calibration or maintenance necessary.
 
EKF Diagnostics CEO Julian Baines said, “The FDA clearance of DiaSpect Tm is part of our overall strategy to widen the range of regulatory approvals for our existing product range and to drive sales growth for these products across additional geographies. The U.S. market is a key target for our DiaSpect Tm product, where we see a significant need for an easy to use, accurate and portable hemoglobin measurement system that can deliver laboratory quality results to patients in the clinic within seconds.”
 
FDA clearance is also a mark of the quality and reliability of a device which is recognized and trusted around the world. Lightweight and palm-sized, DiaSpect Tm is ideal for POCT in remote situations, not only due to its portability and unmatched measurement speed, but also through its rechargeable internal battery. This provides up to 40 days/10,000 tests continuous use, giving the flexibility of not needing a power source for weeks at a time.
 
DiaSpect’s reagent-free cuvettes have up to 2.5 years shelf life, even after opening, and are unaffected by temperature or humidity. These disposable cuvettes can be stored from 0 to 50 degrees Celsius, meaning temperature-controlled storage is not necessary; short term storage is even possible at -30 degrees Celsius to 70 degrees Celsius for 24 hours. This all makes the device highly suited for hemoglobin testing in a range of locations, environments and climatic conditions.
 
EKF Diagnostics Holdings plc, which includes the EKF Diagnostics, Stanbio Laboratory and DiaSpect brands, specializes in the development, production and worldwide distribution of point-of-care analyzers for use in the detection and management of diabetes and anemia, and also in sports and maternal medicine. EKF products are sold in more than 100 countries around the globe, through a network of specialist distributors. Point-of-care diagnostics: EKF Diagnostics designs and manufactures world-class diagnostic devices, as well as distributing rapid test kits for infectious diseases and pregnancy. The EKF analyzer range is used widely in GP surgeries, pharmacies, blood banks, sports clinics, hospitals and laboratories for glucose, lactate, hemoglobin, hematocrit and HbA1c measurement. Central laboratory: EKF, through its wholly owned subsidiary, Stanbio Laboratory (Boerne, Texas), manufactures a comprehensive range of clinical chemistry reagents, as well as associated analyzers. In addition, EKF Life Sciences (Elkhart, Ind.) manufactures enzymes used in reagent development and also provides contract fermentation facilities.