EKF Diagnostics announces US Food and Drug Administration (FDA) 510(k) clearance and CLIA waiver for its handheld, reagent-free hemoglobin analyzer, the DiaSpect Tm. Providing accurate hemoglobin measurements (precision: CV ≤1%) within two seconds of its whole blood-filled cuvette being inserted for analysis, the device ensures quick 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 by a wide range of health care personnel; as such, it is user-friendly and requires minimal training. The user simply collects a capillary or venous blood sample of 10 microliters in the cuvette before inserting straight into the analyzer. It is always ready to use with no re-calibration or maintenance necessary.