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Sanguina Gains FDA 510(k) Clearance for Home-Use Hemoglobin Test

NEW YORK – Home-use test developer Sanguina said Wednesday that it received US Food and Drug Administration 510(k) clearance for a colorimetric self-test to monitor hemoglobin levels.

The Peachtree Corners, Georgia-based firm's AnemoCheck Home is a prescription-use disposable test used to help patients who have anemia due to nutritional deficiency, sickle cell disease, or thalassemia monitor their hemoglobin levels. The test uses a fingerstick blood sample and sample collection tube, and the results are read by comparing the sample color with a hemoglobin level on a color card.

Sanguina previously gained 510(k) clearance in 2017 for a point-of-care version of its semiquantitative AnemoCheck assay for determining total hemoglobin and calculated hematocrit in whole blood. The firm more recently reported in July that it had raised $2.8 million in a Series A financing round that would support expansion of the company's blood health platforms including new tests for circulation and dehydration.