Identification of Microbial Pathogens Directly from Whole Blood Specimens

Published On -

I3CGlobal IVDR, FDA 510k

FDA 510K for Identification of Microbial Pathogens Directly from Whole Blood Specimens

A Nucleic Acid-Based Device for Amplifying, Detecting, And Identifying Microbial Pathogens in Whole Blood Specimens uses technologies like PCR to detect pathogens’ DNA or RNA, providing rapid and accurate results for clinical decision-making.

Intended Use of Nucleic Acid-Based Device for The Amplification, Detection, And Identification of Microbial Pathogens Directly from Whole Blood Specimens

A Nucleic Acid-Based Device for the Amplification, Detection, And Identification of Microbial Pathogens Directly from Whole Blood Specimens is a qualitative in vitro device intended for the amplification, detection, and identification of microbial-associated nucleic acid sequences from patients with suspected bloodstream infections. This device is intended to aid in the diagnosis of bloodstream infection when used in conjunction with clinical signs and symptoms 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 Identification of Microbial Pathogens Directly from Whole Blood Specimens
REQUEST 510K QUOTE
REQUEST IVDR CE MARKING QUOTE

FDA 510K for Identification of Microbial Pathogens Directly from Whole Blood Specimens Device Code and Regulation Number

Sr.

No.

 Product

 Code

 Device Regulation

Description

 Regulation

Number

 Device Class

1

PII

 Candida Species Nucleic Acid Detection System Nucleic Acid-Based Device for The Amplification, Detection, And Identification of Microbial Pathogens Directly from Whole Blood Specimens 21 CFR 866.3960

2

Nucleic Acid-Based Device for The Amplification, Detection, And Identification Of Microbial Pathogens Directly From Whole Blood Specimens

Intended Use

The Candida Species Nucleic Acid Detection System Is a Qualitative Panel for The Direct Detection Of Candida Species In Whole Blood Specimens from patients with symptoms of, or medical conditions predisposing the patients to, invasive fungal infections. The test is indicated for the presumptive diagnosis of candidemia. The test is performed independent of blood culture. Concomitant blood cultures are necessary to recover organisms for susceptibility testing or further identification.

Device Description

The Candida Species Nucleic Acid Detection System comprises reagents, disposables, and accompanying positive and negative controls, with associated instrumentation that performs multiplexed nucleic acid amplification to detect Candida DNA in whole blood specimens, targeting the nucleic acids of Candida species and reporting the results.

System consists of the following components:

  1. Analyzer / Instrumentation
  2. Disposable Test Cartridges / Panels
  3. Controls / Reagents
  4. Software and Interpretation Logic Analyzer software interprets signal data to determine the presence or absence of target microbial nucleic acids. Software includes algorithms for flagging control failures, result validity checks, and documentation output.

Performance Testing (Analytical Nonclinical) for Nucleic Acid-Based Device for The Amplification, Detection, And Identification Of Microbial Pathogens Directly From Whole Blood Specimens

  • Accuracy
  • Precision (Reproducibility, Repeatability)
  • Limit of detection
  • Cross reactivity
  • Interfering substance
  • Specificity
  • Sample Stability / Storage Conditions
  • Demonstrate specimen stability under expected pre-analytical storage conditions.

Real-time and accelerated aging for reagents and cartridges.

  • Software Verification / Validation

Clinical Testing: Required for 510k submission.                     

Recent Posts

Recent Posts