(44 days)
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:
| Performance Metric | Acceptance Criteria (Example) | Reported Device Performance (Not in document, hypothetical) |
|---|---|---|
| Essential Agreement (EA) | ≥ 90% | (e.g., 96.5%) |
| Category Agreement (CA) | ≥ 90% | (e.g., 95.8%) |
| Major Discrepancies (MD) |
§ 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).