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Chembio Diagnostics Submits FDA De Novo/510(k) Request for SARS-CoV-2 Antigen Test System

NEW YORK ─ Point-of-care diagnostic test developer Chembio Diagnostics on Monday announced it has submitted a de novo/510(k) request to the US Food and Drug Administration to enable the marketing of its DPP SARS-CoV-2 Antigen test system.

The system detects SARS-CoV-2 antigens in 20 minutes using a nasal swab and is read by the firm's DPP Micro Reader or DPP Micro Reader 2 optical analyzer.

The de novo/510(k) request reflects Chembio's "long-term strategy … to deliver rapid, decentralized COVID testing solutions and broaden our portfolio of products in other disease categories that require rapid results for the US market," Richard Eberly, the firm's president and CEO, said in a statement.

The Hauppauge, New York-based firm said it has received an award from the US Department of Health and Human Services' Biomedical Advanced Research and Development Authority to support development of a COVID-19 point-of-care antigen test system using the firm's Dual Path Platform (DPP) technology. The award also included funding for the completion of clinical studies and preparation of a de novo/510(k) submission for the rapid DPP SARS-CoV-2 Antigen test system, it said.

Last December, Chembio had announced the BARDA award of $12.7 million, partly for the development of a rapid, multiplex DPP Respiratory Antigen Panel point-of-care system.