Detection of Nucleic Acid from Non-Viral Microorganism(s)

Published On -

I3CGlobal IVDR, FDA 510k

FDA 510k for System for Detection of Nucleic Acid from Non-Viral Microorganism(S) Causing STIS Using Specimens Collected at Home

A System For Detection Of Nucleic Acid from Non-Viral Microorganism(S) Causing STIS Using Specimens Collected at Home refers to a medical device that allows individuals to self-collect samples (like urine or swabs) at home and then send them to a laboratory for analysis using a nucleic acid amplification test (NAAT) to detect the genetic material of non-viral microorganisms responsible for sexually transmitted infections (STIs), like Chlamydia trachomatis or Neisseria gonorrhoeae, without needing a healthcare provider to collect the specimen

Intended Use of System for Detection of Nucleic Acid from Non-Viral Microorganism(S) Causing STIS Using Specimens Collected at Home

The device is an in vitro diagnostic system intended for self-collecting specimens in home settings or similar environments and testing in a clinical laboratory for detection of nucleic acids from non-viral microorganism(s) causing sexually transmitted infections. The device is intended to aid in the diagnosis of sexually transmitted infections. The device is intended for prescription use or over-the-counter use.

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 System for Detection of Nucleic Acid from Non-Viral Microorganism(S) Causing STIS Using Specimens Collected at Home
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FDA 510K for Detection of Nucleic Acid from Non-Viral Microorganism(S) Causing STIS Using Specimens Collected at HomeDevice Code and Regulation Number

S.

No

 Product Code Device Regulation

Number

 Class
1. QYA System For Detection Of Nucleic Acid From Non-Viral Microorganism(S) Causing Stis Using Specimens Collected At Home 866.3385 2

System For Detection of Nucleic Acid from Non-Viral Microorganism(S) Causing STIS Using Specimens Collected at Home

Intended Use: Test is a test system intended for in vitro detection and identification of Chlamydia trachomatis (CT), Neisseria gonorrhoeae (NG), Trichomonas vaginalis (TV), and Mycoplasma genitalium (MG) in home-collected specimens.

Device Descriptions: The device is a diagnostic system designed for the detection of nucleic acids from non-viral microorganisms that cause sexually transmitted infections (STIs). It is intended for use with specimens collected at home, such as swabs or urine samples. The system uses nucleic acid amplification tests (NAATs) to detect the DNA or RNA of pathogens like Chlamydia trachomatis (CT), Neisseria gonorrhoeae (NG), Trichomonas vaginalis (TV), and Mycoplasma genitalium (MG). After the home collection, the specimen is sent to a laboratory for testing, and results are provided to the user in a secure manner. This system offers a convenient and private way for individuals to test for STIs, supporting early detection and treatment.

Performance Testing (Analytical) for System for Detection of Nucleic Acid from Non-Viral Microorganism(S) Causing STIS Using Specimens Collected at Home

  • Accuracy
  • Precision (Reproducibility and Repeatability)
  • Linearity
  • Traceability
  • Sensitivity and Specificity
  • Limit of Detection (LoD), Limit of Quantitation (LoQ), and Limit of Blank (LoB)
  • method comparison
  • Assay cut off.
  • Reference range

Clinical Testing:

No Guidance available for 510k submission.

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