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
FDA 510(k) clearance K161619 · decided 2016-08-29
Clearance details
- K-number
- K161619
- Device name
- 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
- Applicant
- Cepheid
- Decision
- Substantially Equivalent
- Date received
- 2016-06-13
- Decision date
- 2016-08-29
- Days to decision
- 77 days
- Clearance type
- Traditional
- Product code
- OUY
- Device class
- 2
- Regulation number
- 866.3860
- Medical specialty
- Immunology
- Advisory committee
- Immunology
- Location
- Sunnyvale, CA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| Aptima Trichomonas vaginalis Assay (K231316) | Hologic, Inc. | 2023-11-06 |
| BD MAX CTGCTV2, BD MAX System (K182692) | Becton, Dickinson and Company | 2019-01-08 |
| BD MAX CT/GC/TV, BD MAX INSTRUMENT (K151589) | Becton, Dickinson and Company | 2016-09-06 |
| Solana Trichomonas Assay (K161182) | Quidel Corporation | 2016-08-15 |
| 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 (K151565) | Cepheid | 2015-10-16 |
| AmpliVue Trichomonas Assay (K143329) | Quidel Corporation | 2015-03-17 |
| BD PROBETEC TRICHOMONAS VAGINALIS (TV) QX AMPLIFIED DNA ASSAY (K130268) | Becton, Dickinson & CO | 2013-08-23 |
| APTIMA TRICHOMONAS VAGINALIS ASSAY - PANTHER (K122062) | Gen-Probe, Inc. | 2013-01-09 |
| APTIMA TRICHOMONAS VAGINALIS ASSAY (DEN110012) | Gen-Probe Incorporated | 2011-04-19 |
Recalls involving this device
No recalls on record reference this clearance.