EKF secures FDA clearance for DiaSpect Tm POC hemoglobin analyzer

EKF Diagnostics, the global in vitro diagnostics company, announces U.S. Food and Drug Administration 510(k) clearance and CLIA waiver for the Company’s 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%) within two seconds of inserting its whole blood-filled cuvette 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 various settings and by a wide range of healthcare personnel. Essential for this, it is highly user-friendly, requiring minimal training. The user collects a capillary or venous blood sample of 10 µL in the cuvette and then inserts it directly into the analyzer. Additionally, to facilitate POCT use, DiaSpect Tm is factory-calibrated against the HiCN reference method by ICSH. It is ‘always on’ and ready to use, with no recalibration or maintenance required.

Commenting, Julian Baines, CEO of EKF Diagnostics, 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 US 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 recognized and trusted device worldwide. Lightweight and palm-sized, DiaSpect Tm is ideal for point-of-care testing (POCT) in remote situations, not only due to its portability and unmatched measurement speed, but also its rechargeable internal battery. This provides up to 40 days or 10,000 tests of continuous use, offering the flexibility of not requiring a power source for weeks at a time.

DiaSpect’s reagent-free cuvettes have a shelf life of up to 2.5 years, even after opening, and are unaffected by temperature or humidity fluctuations. These disposable cuvettes can be stored between 0 °C and 50°C, eliminating the need for temperature-controlled storage. Additionally, short-term storage is possible at temperatures ranging from -30°C to 70°C for up to 24 hours. This all makes the device highly suited for hemoglobin testing in a range of locations, environments, and climatic conditions.