NxTAG Respiratory Pathogen Panel v2 (NxTAG RPP v2)
FDA 510(k) K231758 · Luminex Molecular Diagnostics, Inc.
Submission
- Device name
- NxTAG Respiratory Pathogen Panel v2 (NxTAG RPP v2)
- Applicant
- Luminex Molecular Diagnostics, Inc.
Toronto, CA - Received
- June 16, 2023
- Decision date
- March 11, 2024
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- QOF – Multi-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial Agents
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.3981
- Specialty
- Microbiology
A device to detect and identify nucleic acid targets in respiratory specimens from microbial agents that cause the SARS-CoV-2 respiratory infection and other microbial agents when in a multi-target test is an in vitro diagnostic device intended for the detection and identification of SARS-CoV-2 and other microbial agents when in a multi-target test in human clinical respiratory specimens from…
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| 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 v2 (NxTAG RPP v2) cleared by the FDA?
NxTAG Respiratory Pathogen Panel v2 (NxTAG RPP v2) (K231758) received a 510(k) decision of Substantially Equivalent on March 11, 2024, 269 days after the submission was received.
What is the product code of K231758?
The FDA product code is QOF – Multi-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial Agents, a Class II (moderate risk) device regulated under 21 CFR 866.3981.