(73 days)
The Sensititre Haemophilus/Streptococcus pneumoniae (HP) MIC Susceptibility plate is an in vitro diagnostic product for clinical susceptibility testing of Streptococcus pneumoniae and Haemophilus influenzae.
This 510(k) is for the addition of Azithromycin in the dilution range of 0.03 - 4 µg/ml to the Sensititre Haemophilus/Streptococcus pneumoniae MIC panel for testing Streptococcus pneumoniae and Haemophilus influenzae isolates. The "Indications for Use" and clinical significance of Azithromycin is for: Streptococcus pneumoniae
Not Found
The provided text is a 510(k) submission approval letter from the FDA for a medical device called "Sensititre™ Haemophilus/Streptococcus pneumoniae (HP) MIC Susceptibility Plates, Azithromycin." This document approves the device for market but does not contain the detailed study information typically found in a clinical trial report or a summary of safety and effectiveness data.
Therefore, I cannot extract the specific information requested about acceptance criteria, device performance, study details, ground truth establishment, or sample sizes from this document. The letter primarily confirms that the FDA has reviewed the submission and found the device substantially equivalent to a legally marketed predicate device.
To answer your questions, I would need access to the actual 510(k) submission, which would include the performance data and methodologies used to support the substantial equivalence claim.
§ 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).