(34 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 Meropenem in the dilution range of 0.016 - 2 ug/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 Meropenem is for: Haemophilus Influenzae (B-lactamase and non-Blactamase producing)
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The provided text is a 510(k) premarket notification letter from the FDA regarding the Sensititre Haemophilus/Streptococcus pneumoniae (HP) MIC Susceptibility Plates, specifically for the addition of Meropenem. While it states that the device is substantially equivalent to a predicate device and permits marketing, it does not contain the detailed acceptance criteria or the study data that proves the device meets those criteria.
Therefore, I cannot extract the information required to fill in the table and answer the study-related questions from the provided text. The document is an approval letter, not a study report or a detailed technical specification.
§ 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).