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K Number
K062190
Device Name
SENSITITRE HAEMOPHILUS / STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATES
Manufacturer
TREK DIAGNOSTIC SYSTEMS, INC.
Date Cleared
2006-08-31

(31 days)

Product Code
JWY,LRG
Regulation Number
866.1640
Type
Traditional
Panel
Microbiology
Reference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended 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-postive microorganisms

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

Device Description

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

AI/ML Overview

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.

§ 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).