510(k) K151565
K151565 is an FDA 510(k) premarket notification submitted by Cepheid for the device "Xpert® TV Assay on the Cepheid GeneXpert Instrument Systems (GeneXpert Dx, GeneXpert Infinity-48, GeneXpert Infinity-48s, and GeneXpertInfinity-80 systems), Xpert Vaginal/Endocervical Specimen Collection Kit, and Xpert Urine Specimen Collection Kit". The FDA issued a decision of Substantially Equivalent on October 16, 2015. The device falls under product code OUY (Trichomonas Vaginalis Nucleic Acid Amplification Test System), a Class II device regulated under 21 CFR 866.3860. Cepheid has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 16, 2015
- Date Received
- June 10, 2015
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Trichomonas Vaginalis Nucleic Acid Amplification Test System
- Device Class
- Class II
- Regulation Number
- 866.3860
- Review Panel
- MI
- Submission Type
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