Antimicrobial Susceptibility Test Powder

A fully automated short-term incubation cycle antimicrobial susceptibility system is a device that incorporates concentrations of antimicrobial agents into a system for the purpose of determining in vitro susceptibility of bacterial pathogens isolated from clinical specimens.                 

Intended Use of Antimicrobial Susceptibility Test Powder

An Antimicrobial Susceptibility Test Powder is a device that consists of an antimicrobial drug powder packaged in vials in specified amounts and intended for use in clinical laboratories for determining in vitro susceptibility of bacterial pathogens to these therapeutic agents. Test results are used to determine the antimicrobial agent of choice in the treatment of bacterial diseases.

Intended Use:

System is an in vitro diagnostic product for clinical susceptibility testing of fastidious isolates.

Device Description:

Manual Antimicrobial Susceptibility Test (AST) Systems are used to assess the effectiveness of various antimicrobial agents against specific microorganisms. These systems help guide appropriate treatment options by determining the minimum inhibitory concentration (MIC) of antibiotics required to inhibit bacterial growth.

Reagent/Device, Inoculum Calibration

Intended Use:

It is an in vitro accessory which aids in the inoculum preparation for use with Dried Gram positive and/or Gram-negative Combo panels for quantitative and qualitative antimicrobial susceptibility testing.

Device Description:

Inoculum calibration is the process of adjusting or verifying the concentration of microorganisms used in laboratory tests, such as antimicrobial susceptibility assays or microbial counts, to ensure consistent and accurate results. This involves calibrating the devices and reagents, such as spectrophotometers or automated microbial counters, to ensure they accurately measure the required microbial concentration. The inoculum is prepared to a specific density, often measured in colony-forming units or optical density, according to the assay’s specifications.

System, Nucleic Acid Amplification Test, Dna, Methicillin Resistant Staphylococcus Aureus, Direct Specimen

Intended Use:

A Nucleic Acid Amplification Assay System (including probes, other reagents, and instrumentation) is an aid in the identification of MRSA colonization status for the prevention and control of MRSA infections in healthcare settings.

Device Description:

A Nucleic Acid Amplification Test (NAAT) is a diagnostic method used to detect Methicillin-Resistant Staphylococcus aureus (MRSA) by amplifying its DNA in direct specimens, such as wound swabs or blood samples. MRSA is a strain of Staphylococcus aureus that is resistant to methicillin and other antibiotics, making it difficult to treat. NAAT targets specific genetic sequences associated with the bacteria, allowing for rapid and accurate detection even in low quantities. This technique is particularly useful for identifying resistant strains like MRSA, providing quick results compared to traditional culture methods.

Phenotypic Test Kit, Non-Susceptible/Elevated Mic Organisms, Cultured Isolates

Intended Use:

Qualitative detection of carbapenemase enzymes in pure colonies of Enterobacteriaceae and Pseudomonas aeruginosa that have elevated MIC values to any Carbapenem.

Device Description:

A Phenotypic Test Kit for Non-Susceptible/Elevated MIC Organisms is used to determine the resistance profiles of microbial isolates (such as bacteria) in a clinical or laboratory setting. It helps identify whether an organism is resistant to specific antibiotics based on phenotypic methods. These tests rely on observable characteristics or behavior of the organism, as opposed to genetic tests that look at the DNA.

• Precision/Reproducibility
• Linearity/assay reportable range
• Detection limit
• Analytical specificity
• Traceability (controls, calibrators, or method)
• Analytical Sensitivity
• Interference

Clinical Testing:

No Guidance available for 510k submission.