510(k) K190441
- Device
- Xpert CT/NG, GeneXpert Dx System, GeneXpert Infinity-48s And GeneXpert Infinity-80 Systems, GeneXpert Infinity-48 System, Xpert Vaginal/Endocervical Specimen Collection, Xpert Urine Specimen Collection Kit, Xpert Swab Specimen Collection Kit
- Applicant
- Cepheid
- 510(k) number
- K190441
- Product code
- QEP
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2019-05-23
- Date received
- 2019-02-25
- Regulation
- 866.3393
- Classification name
- Nucleic Acid Detection System For Non-viral Microorganism(s) Causing Sexually Transmitted Infections
- Medical specialty
- Molecular Genetics
- Review panel
- Microbiology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Yi-Ping Lin
- Address
- 904 Caribbean Dr. Sunnyvale CA US 94089 94089
FDA Registration Numbers#
- 3019837962
- 3012598266
- 3010749841
- 3009613136
- 3004141078
- 2243471
- 2024800
- 2436875
- 3004530258
- 3016838963
- 9610126
- 3005248192
- 3003795116
- 3003630504
- 3002444944
- 1181121
- 3025663244
- 3017907743
- 3016608638
- 3013019728
- 1119779
- 3007420875
- 3038610665
Source Documents#
Other 510(k) Records For Product Code QEP #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K253759 | cobas liat CT/NG/MG nucleic acid test | Roche Molecular Systems, Inc. | 2026-05-15 |
| K253756 | cobas liat CT/NG nucleic acid test | Roche Molecular Systems, Inc. | 2026-05-15 |
| K251501 | Visby Medical Men's Sexual Health Test | Visby Medical, Inc. | 2025-10-01 |
| K243343 | BD CTGCTV2 | Bd Integrated Diagnostic Solutions/Becton, | 2025-04-22 |
| K240217 | cobas® liat CT/NG nucleic acid test | Roche Molecular Systems, Inc. | 2025-01-17 |
| K240197 | cobas® liat CT/NG/MG nucleic acid test | Roche Molecular Systems, Inc. | 2025-01-16 |
| K230267 | NeuMoDx CT/NG Assay 2.0 | Neumodx Molecular, Inc. | 2023-12-22 |
| K220407 | Visby Medical Sexual Health Test | Visby Medical | 2023-03-07 |
| K222379 | Alinity m STI Assay | Abbott Molecular, Inc. | 2023-03-03 |
| K220321 | Aptima Combo 2 Assay (250 test kit) Panther, Aptima Combo 2 Assay (250 test kit) Tigris, Aptima Trichomonas Vaginalis Assay (250 test kit) Panther, Aptima Trichomonas Vaginalis Assay (250 test kit) Tigris | Hologic, Inc. | 2022-06-03 |
| K210585 | BD CTGCTV2 | Becton, Dickinson and Company | 2022-05-10 |
| K202977 | Alinity m STI Assay | Abbott Molecular, Inc. | 2022-04-29 |
| K193081 | Rheonix STI TriPlex Assay, Rheonix EncompassMDx Workstation (instrument and software), Rheonix Urine Specimen Collection Kit | Rheonix, Inc. | 2021-12-17 |
| K200748 | Visby Medical Sexual Health | Visby Medical | 2021-08-26 |
| K202408 | cobas CTNG for use on cobas 6800/8800 systems | Roche Molecular Systems, Inc. | 2021-01-21 |
Legacy Summary#
summary
FDA Review#
Decision Summary