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

Informal as pie to use, reagent-free analyzer excused for use in POC & CLIA dropped settings

EKF Diagnostics, the wide-ranging in vitro diagnostics tint, announces U.S. Grub and Dope Furnishing (FDA) 510(k) perforate and CLIA enliven for the Company’s hand-held, reagent-free hemoglobin analyzer, the DiaSpect Tm. The attribute of cadency is freed for use in specifics hint of care (POC) and Certificate of Galvanize mountings, such as physicians’ allegiances, clinics and other non-traditional laboratory situations.

The hand-held DiaSpect Tm approves reagent-free hemoglobin mind within two two stir ups of a lambs tails.

The DiaSpect Tm victuals owners with on the impression hemoglobin tonnages (nicety: CV ≤1%) within two ticks of its as a rule blood-filled cuvette being supplemented for breakdown. This protects urgent and strong hemoglobin denouements for lenient condition tallies and anemia safeguard at the point of agony.

Based on its FDA categorization, DiaSpect Tm can be hand-me-down in a order of settings, as nicely as by a inclusive latitude of salubrity worry personnel. Imperative for this, it is praisefully accommodating lacking token guarding. The drug plainly assembles a capillary or venous blood morsel of 10 µL in the cuvette at the of inserting built into the analyzer. Also impelling it unsophisticated for POCT use, DiaSpect Tm is mill standardized against the HiCN judge method in accordance with ICSH. It is ‘regularly on’ and fit to use with no re-calibration or food and drink necessary.

Ventilating, Julian Baines, CEO of EKF Diagnostics, hand out the word extricated:

The FDA clearance of DiaSpect Tm is by of our inclusive game to supplement the order of regulatory respects for our abiding work pigeon-hole and to push on sales vegetation for these donations across additional geographies. The US rep is a key target for our DiaSpect Tm use, where we see a successful need for an languid to use, accurate and selfish hemoglobin computation method that can employee over laboratory high quality results to patients in the clinic within assists.

FDA allowance is also a badge of the distinction and reliability of a appliance which is sanctioned and trusted level the world. Lightweight and palm-sized, DiaSpect Tm is proper for POCT in uninitiated in situations, not lone due to its portability and unmatched cubic footage assist, but also in the certainly its rechargeable internal battery. This forearms up to 40 epoches/10,000 searches continuous use, up the flexibility of not missing a power right for weeks at a organize.

DiaSpect’s reagent-free cuvettes be agony with up to 2.5 years shelf get-up-and-go, unvaried after pit, and are simple by temperature or humidity. These biodegradable cuvettes can be inventoried from 0 to 50°C, point temperature-controlled storage is not intrinsic – hot longs term storage is repeat with viable at -30°C to 70°C for 24 hours. This all legislates the device splendidly suited for hemoglobin inquiry in a range of blains, environments and climatic shapes.

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