Resistance Marker Nucleic Acids Directly in Respiratory Specimens

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I3CGlobal FDA 510k, IVDR

FDA 510K for Resistance Marker Nucleic Acids Directly in Respiratory Specimens

A Device To Detect And Identify Microorganisms And Their Associated Resistance Marker Nucleic Acids Directly In Respiratory Specimens would typically consist of a sample preparation module, a nucleic acid extraction system, a PCR amplification unit, and a detection system, all integrated into a single platform, allowing for rapid and on-site analysis of respiratory samples, potentially using techniques like microfluidics to handle small sample volumes and achieve high sensitivity and specificity.

Intended Use of Device to detect and identify microorganisms and associated resistance marker nucleic acids directly in respiratory specimens.

A Device to Detect And Identify Microorganisms And Associated Resistance Marker Nucleic Acids Directly From Respiratory Specimens is an in vitro diagnostic device intended for the detection and identification of microorganisms and associated resistance markers in respiratory specimens collected from patients with signs or symptoms of respiratory infection. The device is intended to aid in the diagnosis of respiratory infection in conjunction with clinical signs and symptoms and other laboratory findings. These devices do not provide confirmation of antibiotic susceptibility since mechanisms of resistance may exist other than those detected by the device.

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 Resistance Marker Nucleic Acids Directly in Respiratory Specimens
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FDA 510K for Resistance Marker Nucleic Acids Directly in Respiratory Specimens Device Code and Regulation Number

S.

No

 Product Code Device Regulation Description Regulation Number Device Class

1.

QBH

 Lower Respiratory Microbial Nucleic Acid Detection System Device to detect and identify microorganisms and associated resistance marker nucleic acids directly in respiratory specimens.

866.3985

2

Lower Respiratory Microbial Nucleic Acid Detection System

Intended use:

Application is a qualitative nucleic acid multiplex test intended for the simultaneous detection and identification of nucleic acid sequences and antibiotic resistance marker in bronchoalveolar lavage (BAL)-like specimens (BAL or mini-BAL) from adult hospitalized patients with suspected lower respiratory tract infections.

Device Description:

It is a multiplex molecular diagnostic system that automates the processes of specimen lysis, DNA purification, amplification, and detection of nucleic acid targets in a single-use cartridge format. The system is intended for use with the analytical platform, which includes the Lysator, Analyzer, and Cockpit instrumentation.

Key Features

  • Multiplex PCR and Array Hybridization
  • Single-Use Cartridge System
  • Integrated Instrumentation
  • Output and Interpretation.

Performance Testing (Analytical-Nonclinical) for Device to Detect And Identify Microorganisms And Associated Resistance Marker Nucleic Acids Directly In Respiratory Specimens.

  • Stability Studies
  • Precision/Reproducibility
  • Detection studies
  • Linearity/assay reportable range
  • Analytical specificity
  • Analytical Sensitivity
  • Analytical Specificity (Cross Reactivity and Inclusivity)
  • Resistance Marker Verification
  • Internal Control Validation
  • Specimen Matrix Equivalence
  • Interfering Substances
  • Prozone effect study
  • Stability Studies
  • Software / Algorithm Verification

 

Clinical Testing: Required for 510k submission.

 

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