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Applied Biocode MDx System, GI Pathogen Panel Get FDA 510(k) Clearance

NEW YORK (GenomeWeb) – Applied BioCode said today that it has received US Food and Drug Administration 510(k) clearance for the BioCode Gastrointestinal Pathogen Panel (GPP) with the BioCode MDx-3000 molecular system.

The BioCode GPP tests for 17 of the most common bacteria, viruses, and parasites that cause infectious diarrhea. It runs on the BioCode MDx-3000, which automates PCR amplification, hybridization/target capture, and detection, and can process up to 94 samples in about 3.5 hours or generate up to 3,196 results in an eight-hour shift, Applied BioCode said.

FDA clearance was based on the results of a clinical study of more than 1,558 prospective samples, archived positives, and contrived samples at multiple hospital-based clinical laboratories around the US.

The clearance "marks a major milestone for our company and provides yet another validation for our digital barcode magnetic bead technology," Applied BioCode President Winston Ho said in a statement. "Our BioCode MDx-3000 system will help medium to large hospitals and clinical laboratories provide automated high-volume syndromic testing to their patients at a lower overall [heathcare] cost."

Ho also noted that the GPP is the first of many syndromic panels the company expects to make available for the system.

Applied Biocode, which is based in Santa Fe Springs, California, submitted the GPP and MDx-3000 for 510(k) clearance in January. The products received CE marking in April.