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Paige, Diatron Receive FDA Clearances in July

NEW YORK ─ With the coronavirus pandemic continuing to attract the attention of diagnostic test makers and the US Food and Drug Administration, the agency granted only a handful of 510(k) clearances in July for in vitro diagnostic products.

Budapest, Hungry-based Diatron received clearance for the Lin-Zhi International Methamphetamine Enzyme Immunoassay running on Diatron's Pictus analyzer. The immunoassay enables rapid screening for d-methamphetamine in human urine at a cutoff value of 500 ng/mL. A more specific alternative analytical chemistry method must be used to obtain a confirmed analytical result, the FDA said. Gas or liquid chromatography/mass spectrometry are the preferred confirmatory methods.

Also last month, New York-based computational pathology firm Paige received 510(k) clearance for use of its FullFocus digital pathology image viewer with the Philips Ultra Fast scanner for primary diagnosis.

In July, Thermo Fisher Scientific announced it received clearance for its blood-based red meat allergy test, while Beckman Coulter's said it received clearance for an automated blood banking analyzer. Both firms received the clearances in May.