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The Sensititre HP Susceptibility System is an in vitro diagnostic product for clinical susceptibility testing of fastidious organisms.

This 510(k) is for the addition of Tigecycline in the dilution range of 0.004 - 8 ug/ml for testing Streptococcus spp. isolates on the Sensititre HP susceptibility system. The approved primary "Indications for Use" and clinical significance of Tigecycline is for:

Aerobic facultative Gram-postive microorganisms

Streptoccus agalactiae Streptococcus pyogenes Streptococcus anginosus grp. (includes S. anginosus, S. intermedius, and . S. constellatus)

Sensititre® Haemophilus influenzae/Streptococcus pneumoniae (HP) MIC susceptibility plates, for Tigecycline 0.004-8 µg/ml for Streptococcus spp.

The provided text is a 510(k) premarket notification letter from the FDA to TREK Diagnostic Systems, Inc. for their Sensititre® Haemophilus influenzae/Streptococcus pneumoniae (HP) MIC susceptibility plates, specifically for the addition of Tigecycline. This document is a regulatory approval letter and does not contain the detailed study information required to answer most of your questions about acceptance criteria, device performance, study design, or ground truth establishment.

The letter confirms legal marketing authorization but refers to the company's 510(k) submission for the underlying data. Therefore, I can only provide information that is explicitly stated or can be inferred from this specific document.

Here's what can be extracted:

• Device Name: Sensititre® Haemophilus influenzae/Streptococcus pneumoniae (HP) MIC susceptibility plates, for Tigecycline 0.004-8 µg/ml for Streptococcus spp.
• Indication for Use: The Sensititre HP Susceptibility System is an in vitro diagnostic product for clinical susceptibility testing of fastidious organisms. This 510(k) is for the addition of Tigecycline in the dilution range of 0.004 - 8 ug/ml for testing Streptococcus spp. isolates on the Sensititre HP susceptibility system. The approved primary "Indications for Use" and clinical significance of Tigecycline is for: Aerobic facultative Gram-positive microorganisms including Streptococcus agalactiae, Streptococcus pyogenes, Streptococcus anginosus grp. (includes S. anginosus, S. intermedius, and S. constellatus).

Since the document is a regulatory approval letter and not the study report itself, most of your questions cannot be answered from the provided text. The requested information such as acceptance criteria, specific performance metrics, sample sizes, expert qualifications, and ground truth methodologies would be detailed in the original 510(k) submission, which is not provided here.

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