Client Case Study

Development

FDA Support

Nuclein

The DASH® Rapid PCR System, is a point-of-care (POC) in vitro diagnostic (IVD) that detects nucleic acids of target pathogens. The first test for the DASH® Rapid PCR System is the FDA-cleared, CLIA-waived DASH® SARS-CoV-2 & Flu A/B Test. The system consists of an instrument, barcode scanner, collection swabs, and test cartridges.

The DASH® Rapid PCR System delivers lab-quality results at the point of care, is simple to use, and can be operated with minimal training.

Assistance provided:

  • IEC 62304 Software compliance
  • Risk Management Plan & Report
  • Preliminary Hazard Analysis
  • Hazard Analysis
  • Design FMEAs
  • FDA Cybersecurity compliance
  • Usability Engineering File

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