Aptima Trichomonas vaginalis Assay
FDA 510(k) K231316 · Hologic, Inc.
510(k) numberK231316
Submission
- Device name
- Aptima Trichomonas vaginalis Assay
- Applicant
- Hologic, Inc.
San Diego, CA, US - Received
- May 8, 2023
- Decision date
- November 6, 2023
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- OUY – Trichomonas Vaginalis Nucleic Acid Amplification Test System
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.3860
- Specialty
- Immunology
In vitro nucleic acid amplification test for the qualitative detection of ribosomal rna from trichomonas vaginalis as an aid in the diagnosis of trichomoniasis from vaginal, cervical, urogenital and gynecological specimens from symptomatic patients
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Questions and answers
When was Aptima Trichomonas vaginalis Assay cleared by the FDA?
Aptima Trichomonas vaginalis Assay (K231316) received a 510(k) decision of Substantially Equivalent on November 6, 2023, 182 days after the submission was received.
What is the product code of K231316?
The FDA product code is OUY – Trichomonas Vaginalis Nucleic Acid Amplification Test System, a Class II (moderate risk) device regulated under 21 CFR 866.3860.