Xpert Xpress Flu/RSV, Xpert Nasopharyngeal Sample Collection Kit, GeneXpert Dx Systems (GX-I, GX-II, GX-IV, GX-XVI), GeneXpert Infinity-48 System and GeneXpert Infinity-48s System, GeneXpert Infinity-80 System
FDA 510(k) K162331 · Cepheid
Submission
- Device name
- Xpert Xpress Flu/RSV, Xpert Nasopharyngeal Sample Collection Kit, GeneXpert Dx Systems (GX-I, GX-II, GX-IV, GX-XVI), GeneXpert Infinity-48 System and GeneXpert Infinity-48s System, GeneXpert Infinity-80 System
- Applicant
- Cepheid
Sunnyvale, CA, US - Received
- August 19, 2016
- Decision date
- February 9, 2017
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- OCC – Respiratory Virus Panel Nucleic Acid Assay System
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.3980
- Specialty
- Microbiology
A respiratory viral panel multiplex nucleic acid assay is a qualitative in vitro diagnostic device intended to simultaneously detect and identify multiple viral nucleic acids extracted from human respiratory specimens or viral culture. The detection and identification of a specific viral nucleic acid from individuals exhibiting signs and symptoms of respiratory infection aids in the diagnosis of…
Other 510(k)s with product code OCC
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K262747 | ID NOW Influenza A & B 2; ID NOW RSV; ID NOW Strep A 2; ID NOW COVID-19 2.0OCC · Special | Abbott Diagnostics Scarborough, Inc. | 08/31/2026SE |
| K254139 | BioCode® Respiratory Pathogen Panel (RPP)OCC · Traditional | Applied BioCode, Inc. | 05/01/2026SE |
| K242613 | NxTAG® Respiratory Pathogen PanelOCC · Special | Luminex Molecular Diagnostics, Inc. | 10/02/2024SE |
| K232775 | ID NOW Influenza A & B 2OCC · Special | Abbott Diagnostics Scarborough, Inc. | 10/10/2023SE |
| K231017 | Panther Fusion AdV/hMPV/RV AssayOCC · Special | Hologic, Inc. | 05/05/2023SE |
| K213822 | cobas Influenza A/B & RSV nucleic acid test for use on the cobas Liat SystemOCC · Special | Roche Molecular Systems, Inc. | 07/06/2022SE |
| K210234 | cobas Influenza A/B & RSV Nucleic acid test for use on the cobas Liat SystemOCC · Special | Roche Molecular Systems, Inc. | 02/16/2021SE |
| K201505 | Simplexa Flu A/B & RSV Direct Gen II, Simplexa Flu A/B & RSV Positive Control PackOCC · Traditional | Diasorin Molecular, LLC | 08/22/2020SE |
| K200065 | cobas Influenza A/B Nucleic acid test for use on the cobas Liat System, cobas Influenza…OCC · Special | Roche Molecular Systems, Inc. | 02/10/2020SE |
| K192485 | BioCode Respiratory Pathogen Panel (RPP)OCC · Traditional | Applied BioCode, Inc. | 12/23/2019SE |
More from Applied BioCode, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K261362 | Xpert Hemorrhagic FeverQVR · Dual Track | 08/07/2026SE |
| K261867 | Xpert Carba-RPOC · Special | 07/02/2026SE |
| K253653 | Xpert Hemorrhagic Fever · Traditional | 02/20/2026SE |
| K251721 | Xpert GI PanelPCH · Traditional | 01/16/2026SE |
| K250996 | Xpert Xpress CoV-2/Flu/RSV plusQOF · Special | 05/01/2025SE |
| K250995 | Xpert Xpress CoV-2/Flu/RSV plusQOF · Special | 05/01/2025SE |
| K243730 | Xpert C. difficile/EpiOZN · Traditional | 02/28/2025SE |
| K250218 | Xpert® FII & FVNPR · Special | 02/21/2025SE |
| K242109 | Xpert® Xpress CoV-2 plus (XPRS-COV2-10)QQX · Dual Track | 01/15/2025SE |
| K242071 | Xpert Xpress CoV-2/Flu/RSV plusQOF · Dual Track | 01/10/2025SE |
Questions and answers
When was Xpert Xpress Flu/RSV, Xpert Nasopharyngeal Sample Collection Kit, GeneXpert Dx Systems (GX-I, GX-II, GX-IV, GX-XVI), GeneXpert Infinity-48 System and GeneXpert Infinity-48s System, GeneXpert Infinity-80 System cleared by the FDA?
Xpert Xpress Flu/RSV, Xpert Nasopharyngeal Sample Collection Kit, GeneXpert Dx Systems (GX-I, GX-II, GX-IV, GX-XVI), GeneXpert Infinity-48 System and GeneXpert Infinity-48s System, GeneXpert Infinity-80 System (K162331) received a 510(k) decision of Substantially Equivalent on February 9, 2017, 174 days after the submission was received.
What is the product code of K162331?
The FDA product code is OCC – Respiratory Virus Panel Nucleic Acid Assay System, a Class II (moderate risk) device regulated under 21 CFR 866.3980.