510(k) K171552
- Device
- Xpert Xpress Flu, Xpert Nasopharyngeal Sample Collection Kit, Xpert Nasal Sample Collection Kit, GeneXpert Xpress II, GeneXpert Xpress IV
- Applicant
- Cepheid
- 510(k) number
- K171552
- Product code
- OCC
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2017-12-19
- Date received
- 2017-05-26
- Regulation
- 866.3980
- Classification name
- Respiratory Virus Panel Nucleic Acid Assay System
- Medical specialty
- Microbiology
- Review panel
- Microbiology
- Device class
- 2
- Clearance type
- Dual Track
- 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#
- 3008632402
- 3010770794
- 3004141078
- 3038610665
- 3023372670
- 3016838963
- 3003795116
- 3012494290
- 3019946577
- 3003018722
- 3002773840
- 3006028115
- 3007799234
- 2023365
- 3021140368
- 3013019728
- 3029059580
- 2243471
- 9610126
- 3005248192
- 9681630
- 3004530258
- 3003030793
- 1650733
- 3010749841
- 2024800
- 3005360469
- 1221359
- 3009613136
- 1528450
- 3002777243
- 3006198300
Source Documents#
Other 510(k) Records For Product Code OCC #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K254139 | BioCode® Respiratory Pathogen Panel (RPP) | Applied BioCode, Inc. | 2026-05-01 |
| K242613 | NxTAG® Respiratory Pathogen Panel | Luminex Molecular Diagnostics, Inc. | 2024-10-02 |
| K232775 | ID NOW Influenza A & B 2 | Abbott Diagnostics Scarborough, Inc. | 2023-10-10 |
| K231017 | Panther Fusion AdV/hMPV/RV Assay | Hologic, Inc. | 2023-05-05 |
| K213822 | cobas Influenza A/B & RSV nucleic acid test for use on the cobas Liat System | Roche Molecular Systems, Inc. | 2022-07-06 |
| K210234 | cobas Influenza A/B & RSV Nucleic acid test for use on the cobas Liat System | Roche Molecular Systems, Inc. | 2021-02-16 |
| K201505 | Simplexa Flu A/B & RSV Direct Gen II, Simplexa Flu A/B & RSV Positive Control Pack | Diasorin Molecular, LLC | 2020-08-22 |
| K200065 | cobas Influenza A/B Nucleic acid test for use on the cobas Liat System, cobas Influenza A/B & RSV Nucleic acid test for use on the cobas Liat System, cobas Strep A Nucleic acid test for use on the cobas Liat System | Roche Molecular Systems, Inc. | 2020-02-10 |
| K192485 | BioCode Respiratory Pathogen Panel (RPP) | Applied BioCode, Inc. | 2019-12-23 |
| K193167 | NxTAG Respiratory Pathogen Panel, NxTAG Respiratory Pathogen Panel Files, SYNCT Software | Luminex Molecular Diagnostics, Inc. | 2019-12-11 |
| K191729 | Cobas Influenza A/B Nucleic Acid Test for Use on the Cobas Liat System | Roche Molecular Systems, Inc. | 2019-07-24 |
| K191534 | ID NOW Influenza A & B 2 | Abbott Diagnostics Scarborough, Inc. | 2019-07-11 |
| K183597 | QIAstat-Dx Respiratory Panel | QIAGEN GmbH | 2019-05-18 |
| K181443 | Accula RSV Test | Mesa Biotech, Inc. | 2018-11-23 |
| K181289 | Xpert Xpress Flu, Xpert Nasopharyngeal Sample Collection Kit, Xpert Nasal Sample Collection Kit, GeneXpert Dx Systems (GX-I, GX-II, GX-IV, GX-XVI), GeneXpert Infinity-48S System and GeneXpert Infinity-80 System | Cepheid | 2018-08-15 |
Legacy Summary#
summary
FDA Review#
Decision Summary