NxTAG Respiratory Pathogen Panel, NxTAG Respiratory Pathogen Panel Files, SYNCT Software
FDA 510(k) K193167 · Luminex Molecular Diagnostics, Inc.
Submission
- Device name
- NxTAG Respiratory Pathogen Panel, NxTAG Respiratory Pathogen Panel Files, SYNCT Software
- Applicant
- Luminex Molecular Diagnostics, Inc.
Toronto, CA - Received
- November 15, 2019
- Decision date
- December 11, 2019
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) statement 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 |
|---|---|---|
| K242613 | NxTAG® Respiratory Pathogen PanelOCC · Special | 10/02/2024SE |
| K231758 | NxTAG Respiratory Pathogen Panel v2 (NxTAG RPP v2)QOF · Traditional | 03/11/2024SE |
| K191161 | xTAG Gastrointestinal Pathogen Panel (GPP)PCH · Special | 11/12/2019SE |
| K191160 | xTAG Gastrointestinal Pathogen Panel (GPP), xTAG Data Analysis Software (TDAS GPP)PCH · Special | 11/04/2019SE |
| K183030 | xTAG Gastrointestinal Pathogen Panel (GPP), xTAG Data Analysis Software (TDAS GPP)PCH · Special | 11/30/2018SE |
| K183023 | xTAG Gastrointestinal Pathogen Panel (GPP), xTAG Data Analysis Software (TDAS GPP)PCH · Special | 11/30/2018SE |
| K170492 | xTAG CYP2D6 Kit v3NTI · Special | 08/11/2017SE |
| K163347 | xTAG Cystic Fibrosis 39 Kit v2NUA · Special | 12/15/2016SESK |
| K163336 | xTAG Cystic Fibrosis 60 Kit v2, xTAG Data Analysis Software (TDAS) CFTRNUA · Special | 12/15/2016SESK |
| K152386 | NxTAG Respiratory Pathogen Panel, NxTAG Respiratory Pathogen Panel Files, SYNCT SoftwareOCC · Traditional | 12/17/2015SE |
Questions and answers
When was NxTAG Respiratory Pathogen Panel, NxTAG Respiratory Pathogen Panel Files, SYNCT Software cleared by the FDA?
NxTAG Respiratory Pathogen Panel, NxTAG Respiratory Pathogen Panel Files, SYNCT Software (K193167) received a 510(k) decision of Substantially Equivalent on December 11, 2019, 26 days after the submission was received.
What is the product code of K193167?
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.