(35 days)
The Sensititre® Haemophilus influenzae/Streptococcus pneumoniae (HP) MIC Susceptibility plate is and I he Sellstitle= Huemophilus influence&oldid=918888888888888888888888888888888888888888888888888888888888888888888888888888888888888888888888888888888888888888888888888888888 Streptococcus species.
This 510(k) is for the addition of Streptococcus spps to cefepime (0.12 - 8 ug/mL), ceftrianone (0.06-2 I I IIIS SIV(K) is for the addition of Shippoooooal vipps Sensitite® Haemophilus influenzae/Streptococcus pneumoniae (HP) MIC Susceptibility Plates .
oneumonde (HF) MIC Susceptionity Frates -
Viridans group streptococci. Streptococcus pneumoniae, Streptococcus pyogenes With activity against: Streptococcus agalactiae " " Sheptococcas agatachas for use" and clinical significance of ceftriaxone is for
Viridans group streptococci.
Streptococcus pneumoniae,
Streptococcus pyogenes
The following in vitro data are available but their clinical significance is unknown:
Streptococcus agalactiae
" "Streptococcas ugadestions for use" and clinical significance of chloramphenicol is for: Streptococcus pneumoniae
Streptococcus spp.
Not Found
The provided text describes a 510(k) premarket notification for a medical device called "Sensititre® Haemophilus inflenzae/Streptococcus pneumoniae (HP) MIC susceptibility plates." This device is used for determining the antimicrobial susceptibility of various Haemophilus and Streptococcus species to specific antibiotics (Cefepime, Chloramphenicol, and Ceftriaxone). However, the document does not contain the acceptance criteria or the study details proving the device meets those criteria.
The text is a communication from the FDA indicating that the device has been found substantially equivalent to a legally marketed predicate device, thus allowing it to proceed to market. It outlines regulatory information, product codes, and class designation. The "Indications for Use" section lists the specific bacterial species and antibiotics for which the device is intended.
Therefore, based solely on the provided text, I cannot complete the table or answer the questions regarding acceptance criteria and study details. The document is a regulatory approval letter, not a scientific study report.
§ 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).