EKF receives FDA clearance and CLIA waiver for reagent-free hemoglobin analyzer

Easy to use, reagent-free analyzer cleared for use in POC & CLIA waived settings

EKF Diagnostics, the global in vitro diagnostics company, announces U.S. Food and Drug Administration (FDA) 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 hand-held DiaSpect Tm enables reagent-free hemoglobin analysis within two seconds. Image credit: EKF Diagnostics

The DiaSpect Tm provides users with accurate hemoglobin measurements (precision: CV ≤1%) 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.

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 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°C, meaning temperature-controlled storage is not necessary - short term storage is even possible at -30°C to 70°C for 24 hours. This all makes the device highly suited for hemoglobin testing in a range of locations, environments and climatic conditions.