EKF Diagnostics, the global in vitro diagnostics company, announces that it has signed a private label distribution agreement with McKesson Medical-Surgical Inc. for the Company’s hand-held reagent-free hemoglobin analyzer, the DiaSpect Tm.
EKF’s hand-held analyzer enables reagent-free hemoglobin analysis within two seconds.
McKesson is the oldest and largest healthcare company in the U.S., serving more than 50% of U.S. hospitals and 20% of physicians. The DiaSpect Tm is the world’s fastest hemoglobin analyzer and will be sold in the U.S. from February 2019 by McKesson under its own branded line, as the McKesson Consult® Hb analyzer.
The agreement follows US Food and Drug Administration 510(k) clearance and CLIA waiver by statute for the DiaSpect Tm in April 2018, approving the product for use in point of care (POC) and Certificate of Waiver settings, such as physicians’ offices, clinics, and other non-traditional laboratory locations. Prior to signing the agreement McKesson also undertook its own comprehensive evaluation of the POC hemoglobin analyzer, confirming its quality and reliability.
The DiaSpect Tm gives physicians access to an easy-to-use, accurate and portable hemoglobin measurement system able to deliver laboratory quality results at the point-of-care within seconds.
This agreement with McKesson allows us to offer our innovative POC hemoglobin analysis technology to physicians and childcare specialists across the U.S. through the market’s leading and most established healthcare distribution player. It also affirms the quality of EKF’s product and manufacturing capabilities.
Julian Baines, CEO of EKF Diagnostics.
We are excited to partner with EKF Diagnostics to offer this industry leading technology, providing physicians a convenient design and fast, accurate results for onsite blood testing.
The McKesson Consult® Hb analyzer demonstrates McKesson Brands’ ongoing commitment to offering value-oriented lab solutions to assist our customers in providing improved care for their patients.
Christopher Rogers, Vice President, McKesson Brands.
The palm-sized, lightweight DiaSpect Tm provides users in a variety of care settings with laboratory 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 range of environments, as well as by a broad scope of health care personnel. Essential for this, it is highly user-friendly requiring minimal training. For example, the analyzer’s sampling microcuvette has been designed to collect a blood sample from any angle without forming air bubbles.
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.