PREMARKET SUBMISSIONS

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.

When a 510(K) submission is required:

  • 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.

Medical Devices

We can use the PMM to test for bacterial adhesion to and host cell toxicity of experimental devices.

Learn more here

 

Urogenital Health

Since much of the human genital tract is composed of mucosal tissue, the PMM can be used for predictive preclinical testing of compounds or products related to urogenital health.

Learn more here

Inflammation and Biocompatibility

The PMM offers a unique way to investigate inflammatory cytokine concentrations in a cost-effective manner. We can perform ELISAs and multiplex assays to determine whether experimental compounds are pro- or anti-inflammatory.

Learn more here

Infectious Diseases

Mucosal tissue is an ideal environment for microbial growth, making the PMM an excellent application for testing the efficacy of products to treat infectious disease pathogens. We can test for efficacy against planktonic and biofilm infections with this model.

Learn more here

Get in Touch

We are happy to help with your microbiological requirements and with any other queries you may have.

Get in touch with us today

Perfectus Biomed

Perfectus Biomed, a UKAS accredited microbiological contract testing company, represents the new wave of scientific businesses that are proud to call Daresbury home.

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