510(k) K161619
K161619 is an FDA 510(k) premarket notification submitted by Cepheid for the device "Xpert TV, Xpert Urine Specimen Collection Kit, GeneXpert Dx Systems (GX-I, GX-II, GX-IV, GX-XVI), GeneXpert Infinity-48, Genxpert Infinity-48s and GeneXpert Infinity-80 Systems". The FDA issued a decision of Substantially Equivalent on August 29, 2016. 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
- August 29, 2016
- Date Received
- June 13, 2016
- 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