Premarket Notification 510(k) Submission Support

Perfectus Biomed support companies with their data generation portfolio in order to support their 510(k) submission.

The FDA require 510(k) premarket submissions for new devices that are not subject to Post Market Approval (PMA). The submission demonstrates that a device to be marketed is at least as safe and effective as a legally marketed device (21 CFR 807.92(a)(3)). Submitters must compare their device to one or more similar legally marketed devices.

 

Requirement of 510(K) submissions:

  • When commercial distribution of a new device is occurring for the first time.
  • When there is a change/modification to an existing legally marketed device that may affect its safety or effectiveness.

 

If you would like more information or you wish to discuss this further, please contact us.

Our library of test organism includes…

Choose from our library of test organism including standard reference strains, clinical isolates and environmental isolates.

Single or mixed species assays containing:

Acinetobacter baumannii
Actinomyces naeslundii
Adenovirus (human)
Aspergillus brasiliensis
Aspergillums niger
Aureobasidium pullulans
Bacillus cereus
Bacillus subtilis
Camplylobacter jejuni
Candida albicans
Clostridium difficile
Corynebacterium minutissimum
Enterobacter cloacae
Enterococcus faecalis
Enterococcus faecium (VRE)
Enterococcus hirae
Escherichia coli
Fusobacterium nucleatum
Haemophilus influenzae
Heliocbacter pylori
Halomonas magadiensis
Klebsiella pneumoniae
Lactobacillus casei
Neisseria gonorrhoeae
Neisseria subflava
Porphyromonas ginigvalis
Prevotella nigrescens
Propionibacterium acnes
Proteus mirabilis
Pseudomonas aeruginosa
Salmonella enteritidis
Shigella dysenteriae
Staphylococcus aureus (MRSA and MSSA)
Staphylococcus epidermidis
Staphylococcus haemolyticus
Stenotrophomonas maltophilia
Streptococcus mutans
Streptococcus oralis
Streptococcus pneumoniae
Streptococcus pyogenes
Streptococcus zooepidemicus
Tannerella forsythia
Trichophyton rubrum
Veillonella dispar
WHO Priority organisms.

Other- please ask.