Product Code: OJY FDA class 2 21 CFR 866.3236

Device To Detect Or Measure Nucleic Acid From Viruses Associated With Head And Neck Cancers

Microbiology

The Device to Detect or Measure Nucleic Acid from Viruses Associated with Head and Neck Cancers is a prescription-use in vitro diagnostic test that detects viral nucleic acid (such as HPV or EBV) in nasopharyngeal or oropharyngeal cellular specimens from patients with signs and symptoms of head and neck cancer, intended to aid clinicians in assessing clinical status or the likelihood of virus-associated head and neck cancer in conjunction with other clinical information. Classified as FDA Class 2 under regulation 21 CFR 866.3236 within the Microbiology medical specialty, it requires a 510(k) premarket notification. The product code is OJY. It is not flagged as an implant or life-sustaining device.

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Basic Information

Product Code: OJY
Device Class: FDA class 2
Regulation Number: 866.3236
Medical Specialty: Microbiology
Review Panel: MI
Submission Type: 1

Device Characteristics

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GMP Exempt

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Implant

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Life Sustain/Support

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Third Party

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Summary Malfunction Reporting

Definition

A device to detect or measure nucleic acid from viruses associated with head and neck cancers is an in vitro diagnostic test for prescription use in the detection of viral nucleic acid in nasopharyngeal or oropharyngeal cellular specimens from patients with signs and symptoms of head and neck cancer. The test result is intended to be used in conjunction with other clinical information to aid in assessing the clinical status of virus-associated head and neck cancers and/or the likelihood that head and neck cancer is present.