Detection of Mycobacterium Tuberculosis Complex (MTB-Complex)

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I3CGlobal FDA 510k, IVDR

FDA 510K for Nucleic Acid-Based In Vitro Diagnostic Devices for the Detection of Mycobacterium Tuberculosis Complex (MTB-Complex) And the Genetic Mutations Associated With MTB-Complex Antibiotic Resistance in Respiratory Specimens

Nucleic Acid-Based In Vitro Diagnostic Devices for the Detection of Mycobacterium Tuberculosis Complex In Respiratory Specimens are qualitative nucleic acid-based in vitro diagnostic devices intended to detect M. tuberculosis complex nucleic acids extracted from human respiratory specimens

 

Intended Use of Nucleic Acid-Based In Vitro Diagnostic Devices for The Detection of Mycobacterium Tuberculosis Complex (MTB-Complex) and the Genetic Mutations Associated with MTB-Complex Antibiotic Resistance in Respiratory Specimens

The test is intended for use with specimens from patients for whom there is clinical suspicion of tuberculosis (TB) and who have received no antituberculosis therapy, or less than 3 days of therapy. This test is intended as an aid in the diagnosis of pulmonary tuberculosis when used in conjunction with clinical and other laboratory findings.

For a detailed proposal with a Statement of Work, please complete the Request for Quote (RFQ) form provided separately for FDA 510(k) and IVDR CE Marking for Nucleic Acid-Based In Vitro Diagnostic Devices for The Detection of Mycobacterium Tuberculosis Complex (MTB-Complex) And the Genetic Mutations Associated With MTB-Complex Antibiotic Resistance in Respiratory Specimens
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FDA 510K for MTB-Complex Antibiotic Resistance in Respiratory Specimens Device Code and Regulation Number

S.

No

 Product Code Device Regulation Description Regulation Number Class
 

 

1

  

 

PEU

 System, Nucleic Acid-Based, Mycobacterium Tuberculosis Complex, Resistance Marker, Direct Specimen Nucleic Acid-Based In Vitro Diagnostic Devices for The Detection of Mycobacterium Tuberculosis Complex (MTB-Complex) and the Genetic Mutations Associated With MTB-Complex Antibiotic Resistance in Respiratory Specimens 866.3373 2

 

System, Nucleic Acid-Based, Mycobacterium Tuberculosis Complex, Resistance Marker, Direct Specimen

Intended use:

It is a qualitative, nested real-time polymerase chain reaction (PCR) in vitro diagnostic test for the detection of Mycobacterium tuberculosis complex DNA in raw sputum or concentrated sputum sediment prepared from induced or expectorated sputum. In specimens where Mycobacterium tuberculosis complex (MTB-complex) is detected, the Xpert MTB/RI Assay also detects the Rifampin-resistance-associated mutations of the rpoB gene.

Device description:

The system is a qualitative, automated, in vitro diagnostic test for the qualitative detection of Mycobacterium tuberculosis (MTB) complex DNA in raw sputum samples or in concentrated sputum sediments prepared from induced or expectorated sputa that are either acid-fast bacilli (AFB) smear positive or negative. System automates and integrates sample preparation, nucleic acid amplification, and detection of the target sequences in simple or complex samples using real-time PCR. The system requires the use of single-use disposable cartridges that hold the PCR reagents and host the PCR process. Because the cartridges are self-contained, cross-contamination between samples is minimized.

Performance Testing (MTB-Complex) and the Genetic Mutations Associated with MTB-Complex Antibiotic Resistance in Respiratory Specimens

  • Precision (Reproducibility and Repeatability)
  • Assay reportable range
  • Accuracy
  • Traceability
  • Sensitivity and Specificity
  • Limit of Detection (LoD), Limit of Quantitation (LoQ), and Limit of Blank (LoB)
  • Transportation stability
  • Method comparison

Clinical Testing:

No Guidance available for 510k submission

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