(38 days)
The Sensitire® Haemophilus influenzae/Streptococcus pneumoniae (HP) MIC Susceptibility plate is an in vitro diagnostic product for clinical susceptibility testing of Haemophilus influenzae, Streptococcus pneumoniae and Streptococcus species.
This 510(k) is for the addition of Streptococcus spps to Cefuroxime (0.5 -4 ug/mL), Gatifloxacin (1-8 ug/mL), Erythromycin (0.25-1 ug/ml) for use with the Sensititre® Haemophilus influenzae/Streplooccus pneumoniae (HP) MIC Susceptibility Plates .
The approved primary "indications for use" and clinical significance of Cefuroxime is for: Streptococcus pneumoniae, Streptococcus pyogenes
The approved primary "indications for use" and clinical significance of Gatifloxacin is for Streptococcus pneumoniae, Streptococcus pyogenes
The following in vitro data are available but their clinical significance is unknown:
_Viridans group streptococci
Streptococcus agalactiae
The approved primary "indications for use" and clinical significance of Erythromycin is for: Streptococcus pneumoniae Streptococcus pyogenes
Not Found
This document is a 510(k) premarket notification decision letter from the FDA for an antimicrobial susceptibility test device. It primarily discusses the regulatory approval process and states that the device is substantially equivalent to a legally marketed predicate device.
The provided text does not contain the detailed study results, acceptance criteria, or performance data typically found in a scientific study report or the full 510(k) submission. It only mentions the "addition of Streptococcus spps to Cefuroxime (0.5 -4 ug/mL), Gatifloxacin (1-8 ug/mL), Erythromycin (0.25-1 ug/ml) for use with the Sensititre® Haemophilus influenzae/Streptooccus pneumoniae (HP) MIC Susceptibility Plates" as the subject of the 510(k).
Therefore, I cannot provide the requested information about acceptance criteria, reported device performance, sample sizes, ground truth establishment, or multi-reader multi-case studies based solely on the provided text. The document refers to "in vitro data are available but their clinical significance is unknown," indicating there was testing, but the specifics are not included here.
To answer your questions accurately, I would need access to the actual 510(k) submission summary or a scientific study report for the Sensititre® Haemophilus influenzae/Streptococcus pneumoniae (HP) MIC susceptibility plates.
§ 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).