(33 days)
The Sensititre 20 - 24 hour Haemophilus influenzae/Streptococus pneumoniae MIC or Breakpoint Susceptibility System is an in vitro diagnostic product for clinical susceptibility testing of fastidious isolates. This 510(k) is for Delafloxacin in the dilution range of 0.00025-8 ug/ml for testing fastidious Streptococcus spp. on the Sensitite 20 - 24 hour Haemophilus influenzae/Streptococcus pneumoniae MIC or Breakpoint Susceptibility System. The approved primary "Indications for Use" and clinical significance for fastidious Streptococcus spp. isolates: Streptococcus pyogenes Streptococcus agalactiae Streptococcus anginosus grp.
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This document is a 510(k) clearance letter for an in vitro diagnostic device, the Sensititre 20-24 Hour Haemophilus influenzae/Streptococcus pneumoniae MIC or Breakpoint Susceptibility System with Delafloxacin. It does not contain information about acceptance criteria or supporting studies in the format requested. The letter confirms substantial equivalence to a predicate device and outlines regulatory responsibilities, but does not include detailed performance data or study specifics. Therefore, I cannot extract the requested information from the provided text.
§ 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).