The United States Food and Drug Administration (FDA) has cleared PrimeStore® MTM for the following indication based on data submitted as part of a De Novo 510k filing.
PrimeStore®MTM is intended for the stabilization, transportation and inactivation of infectious unprocessed nasal washes suspected of containing Influenza A virus RNA. PrimeStore® MTM is also intended for the stabilization, transportation and inactivation of infectious unprocessed sputum samples suspected of containing Mycobacterium tuberculosis DNA from human samples.
PrimeStore® MTM has been demonstrated to completely inactivate viruses including, Adenovirus, Foot and Mouth Disease African Swine fever, and Blue Tongue ), bacteria (e. coli, MRSA, and P. aeruginosa), fungi (C. albicans, A. niger), and parasites (Cryptosporidium*). Multiple studies have demonstrated that PrimeStore® MTM reduces Bacillus spores by three to four logs. Samples suspected of containing spores should be treated as though viable spores remain.
*No bead beating or heating required