FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
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
K Number: K151565
·
Decision Oct 16, 2015
Classifications
1
FEI Numbers
14
Registration Numbers
14
Same Product Code
9
Applicant Total
50
Review Days
128
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Basic Information
- Device Name
- 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
- K Number
- K151565
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.3860
- Medical Specialty
- Immunology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Cepheid
- Date Received
- June 10, 2015
- Decision Date
- October 16, 2015
- Product Code
- OUY
- Advisory Committee
- Immunology
- Review Advisory Committee
- MI
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| OUY | Trichomonas Vaginalis Nucleic Acid Amplification Test System | FDA class 2 | Immunology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (OUY), ordered by most recent decision date.
Aptima Trichomonas vaginalis Assay
FDA 510(k)
FDA Class 2
·Immunology
BD MAX CTGCTV2, BD MAX System
FDA 510(k)
FDA Class 2
·Immunology
BD MAX CT/GC/TV, BD MAX INSTRUMENT
FDA 510(k)
FDA Class 2
·Immunology
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)
FDA Class 2
·Immunology
Solana Trichomonas Assay
FDA 510(k)
FDA Class 2
·Immunology
AmpliVue Trichomonas Assay
FDA 510(k)
FDA Class 2
·Immunology
Other Clearances by Cepheid
| K Number | Device Name | ||
|---|---|---|---|
| K253653 | Xpert Hemorrhagic Fever | Feb 20, 2026 | Substantially Equivalent |
| K251721 | Xpert GI Panel | Jan 16, 2026 | Substantially Equivalent |
| K250218 | Xpert® FII & FV | Feb 21, 2025 | Substantially Equivalent |
| K242071 | Xpert Xpress CoV-2/Flu/RSV plus | Jan 10, 2025 | Substantially Equivalent |
| DEN240016 | Xpert HCV; GeneXpert Xpress System | Jun 27, 2024 | Unknown |
| K231381 | Xpert Xpress MVP; GeneXpert Xpress System | Oct 19, 2023 | Substantially Equivalent |
| K222638 | Xpert® Xpress GBS, GeneXpert® Dx System, GeneXpert® Infinity Systems | Sep 27, 2023 | Substantially Equivalent |
| K221160 | Xpert Xpress MVP, GeneXpert Dx System, GeneXpert Infinity System | Jun 7, 2022 | Substantially Equivalent |
| K203429 | Xpert GBS LB XC, GeneXpert Dx System, GeneXpert Infinity System | May 9, 2022 | Substantially Equivalent |
| K212213 | Xpert Xpress MVP, GeneXpert Dx System, GeneXpert Infinity System | Feb 9, 2022 | Substantially Equivalent |