These references should be divided into four sections, SaMD, 510k, cybersecurity, and sterility. The medical device is an at-home PCR machine. Primers can be ordered directly from the system. Polymerases are already installed in the machine. A blood lancet is also included. Use all the references and make the article into five paragraphs, Opening sentence, SaMD, 510k pathway as class II medical device, cybersecurity, and sterility.