NxTAG® Respiratory Pathogen Panel
FDA 510(k) K242613 · Luminex Molecular Diagnostics, Inc.
Submission
- Device name
- NxTAG® Respiratory Pathogen Panel
- Applicant
- Luminex Molecular Diagnostics, Inc.
Toronto, CA - Received
- September 3, 2024
- Decision date
- October 2, 2024
- 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 |
| 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 |
| K193167 | NxTAG Respiratory Pathogen Panel, NxTAG Respiratory Pathogen Panel Files, SYNCT SoftwareOCC · Special | Luminex Molecular Diagnostics, Inc. | 12/11/2019SE |
More from Luminex Molecular Diagnostics, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K231758 | NxTAG Respiratory Pathogen Panel v2 (NxTAG RPP v2)QOF · Traditional | 03/11/2024SE |
| K193167 | NxTAG Respiratory Pathogen Panel, NxTAG Respiratory Pathogen Panel Files, SYNCT SoftwareOCC · Special | 12/11/2019SE |
| 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 cleared by the FDA?
NxTAG® Respiratory Pathogen Panel (K242613) received a 510(k) decision of Substantially Equivalent on October 2, 2024, 29 days after the submission was received.
What is the product code of K242613?
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.