(55 days)
The Sensititre Haemophilus influenzae/Streptococcus pneumoniae plates are in vitro diagnostic products for clinical susceptibility testing of Haemophilus influenzae,Streptococcus pneumoniae and Streptococcus species. This 510(k) is for the addition of Clindamycin in the dilution range of 0.015-1ug/ml to the Sensititre HP MIC susceptibility plate for testing Streptococcus species. The approved primary "Indications for Use" and clinical significance of Clindamycin is for: Faculative Gram-Positive Fastidious Microorganisms: Streptococcus pyogenes Streptococcus agalactiae Streptococcus anginosus
Not Found
This FDA 510(k) clearance letter pertains to the Sensititre Haemophilus influenzae/Streptococcus pneumoniae Susceptibility Plates, specifically for the addition of Clindamycin for testing Streptococcus species. While the document indicates that studies were conducted to support the substantial equivalence of the device, it does not contain the detailed study results, acceptance criteria, or performance data.
The letter is a regulatory approval document confirming that the device is substantially equivalent to legally marketed predicate devices, based on information provided in the 510(k) submission. It refers to "indications for use stated in the enclosure," and the enclosure (page 2) details the specific indication for Clindamycin.
Therefore, I cannot provide the requested information from this document. To answer your questions, one would need access to the full 510(k) submission document, which would include the clinical and analytical study reports.
§ 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).