(128 days)
The "Sensititre® 18 - 24 hour MIC or Breakpoint Susceptibility System" is an in vitro diagnostic product for clinical susceptibility testing of gram positive and gram negative organisms. This 510(k) is for addition of Minocycline in the dilution range of 0.03 - 32μg/ml for testing gram negative and gram positive isolates on the Sensititre® 18 - 24 hour Susceptibility system. The approved primary "Indications for Use" and clinical significance of Minocycline is for: Aerobic and facultative Gram-negative and Gram-positive microorganisms: Escherichia coll Klebsiella spp. Enterobacter aerogenes Acinetobacter spp. Staphylococcus aureus* *Minocycline is not the drug of choice in the treatment of any type of staphylococcal infection.
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The provided text is an FDA 510(k) clearance letter and an "Indications for Use" statement for a medical device. It does not include information about acceptance criteria, study design, or performance metrics. Therefore, I cannot extract the requested information from the provided text.
The document states that the Sensititre 18-24 hour Susceptibility Plates with Minocycline are "substantially equivalent" to legally marketed predicate devices, meaning it has been deemed safe and effective for its stated indications for use based on comparison to existing devices, not necessarily a new clinical study.
To provide the requested details, I would need a different document, such as a summary of safety and effectiveness data, a clinical study report, or a regulatory submission detailing the validation of the device.
§ 866.1640 Antimicrobial susceptibility test powder.
(a)
Identification. 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.(b)
Classification. Class II (performance standards).