Search Results

The Sensititre HP MIC Susceptibility plate is an in vitro diagnostic product for clinical susceptibility testing of fastidious isolates.

The Sensititre 18 - 24 hour MIC or Breakpoint Susceptibility System is an in vitro diagnostic product for clinical susceptibility testing of nonfastidious isolates.

This 510(k) is for the addition of Ceftaroline in the dilution range of 0.004-8ug/ml to the Sensititre HP MIC Susceptibility plate for testing Streptococcus spp. and the Sensititre 18 - 24 hour MIC panel in the dilution range of 0.06-64ug/ml for testing gram positive isolates. The organisms which may be used for Ceftaroline susceptibility testing in this panel are:

Facultative Gram-Positive Microorganisms: Staphylococcus aureus (including methicillin-resistant isolates) Streptococcus pyogenes Streptococcus agalactiae Streptococcus pneumoniae

Not Found

The provided text is a 510(k) premarket notification letter from the FDA regarding an antimicrobial susceptibility test (AST) device. It does not contain information about acceptance criteria, device performance tables, study designs (sample sizes, data provenance, expert adjudication, MRMC studies, standalone performance), or ground truth establishment methods in the depth requested.

The document primarily focuses on:

• Device Identification: Sensititre HP MIC Susceptibility Plate with Ceftaroline (0.004-8ug/ml) and The Sensititre® 18-24 Hour MIC Susceptibility System Test Panel with Ceftaroline (0.06-64ug/ml).
• Regulatory Classification: Class II, Product Code JWY, LRG.
• Indications for Use: Clinical susceptibility testing of fastidious (Sensititre HP) and nonfastidious (Sensititre 18-24 hour MIC) isolates. Specifically for Ceftaroline susceptibility testing of Staphylococcus aureus (including methicillin-resistant isolates), Streptococcus pyogenes, Streptococcus agalactiae, and Streptococcus pneumoniae.
• FDA Clearance: A determination of substantial equivalence to predicate devices, allowing the device to be marketed.

Therefore, I cannot provide the requested information about acceptance criteria, device performance, or study details, as it is not present in the provided text.

To answer your questions, I would need a detailed study report, a summary of safety and effectiveness, or a more comprehensive technical document from the manufacturer or FDA submission.

Ask a specific question about this device