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The Sensititre Haemophilus/Streptococcus pneumoniae (HP) MIC Susceptibility plate is an in vitro quantitative and qualitative susceptibility testing of Streptococcus pneumoniae and Haemophilus influenzae. This 510(k) is for the addition of Clarithromycin in the dilution range of 0.016 - 16 µg/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 Clarithromycin is for: Streptococcus pneumoniae

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Here's a breakdown of the acceptance criteria and study information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document is a 510(k) clearance letter for a modified antimicrobial susceptibility testing plate, specifically for the addition of Clarithromycin. It does not contain a table of acceptance criteria or detailed performance data. Instead, it states that the device is "substantially equivalent" to legally marketed predicate devices.

To provide an example relevant to this type of device, typical acceptance criteria for an antimicrobial susceptibility test (AST) in a 510(k) submission would involve demonstrating acceptable agreement with a reference method (e.g., broth microdilution or agar dilution). The performance metrics would generally be:

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