FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇦 Canada
NxTAG Respiratory Pathogen Panel, NxTAG Respiratory Pathogen Panel Files, SYNCT Software
K Number: K193167
·
Decision Dec 11, 2019
Classifications
1
FEI Numbers
29
Registration Numbers
29
Same Product Code
77
Applicant Total
10
Review Days
26
Basic Information
- Device Name
- NxTAG Respiratory Pathogen Panel, NxTAG Respiratory Pathogen Panel Files, SYNCT Software
- K Number
- K193167
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 866.3980
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Luminex Molecular Diagnostics, Inc.
- Date Received
- November 15, 2019
- Decision Date
- December 11, 2019
- Product Code
- OCC
- Advisory Committee
- Microbiology
- Review Advisory Committee
- MI
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| OCC | Respiratory Virus Panel Nucleic Acid Assay System | FDA class 2 | Microbiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (OCC), ordered by most recent decision date.
NxTAG® Respiratory Pathogen Panel
FDA 510(k)
FDA Class 2
·Microbiology
ID NOW Influenza A & B 2
FDA 510(k)
FDA Class 2
·Microbiology
Panther Fusion AdV/hMPV/RV Assay
FDA 510(k)
FDA Class 2
·Microbiology
cobas Influenza A/B & RSV nucleic acid test for use on the cobas Liat System
FDA 510(k)
FDA Class 2
·Microbiology
cobas Influenza A/B & RSV Nucleic acid test for use on the cobas Liat System
FDA 510(k)
FDA Class 2
·Microbiology
Simplexa Flu A/B & RSV Direct Gen II, Simplexa Flu A/B & RSV Positive Control Pack
FDA 510(k)
FDA Class 2
·Microbiology
Other Clearances by Luminex Molecular Diagnostics, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K242613 | NxTAG® Respiratory Pathogen Panel | Oct 2, 2024 | Substantially Equivalent |
| K231758 | NxTAG Respiratory Pathogen Panel v2 (NxTAG RPP v2) | Mar 11, 2024 | Substantially Equivalent |
| K191161 | xTAG Gastrointestinal Pathogen Panel (GPP) | Nov 12, 2019 | Substantially Equivalent |
| K191160 | xTAG Gastrointestinal Pathogen Panel (GPP), xTAG Data Analysis Software (TDAS GPP) | Nov 4, 2019 | Substantially Equivalent |
| K183023 | xTAG Gastrointestinal Pathogen Panel (GPP), xTAG Data Analysis Software (TDAS GPP) | Nov 30, 2018 | Substantially Equivalent |
| K183030 | xTAG Gastrointestinal Pathogen Panel (GPP), xTAG Data Analysis Software (TDAS GPP) | Nov 30, 2018 | Substantially Equivalent |
| K170492 | xTAG CYP2D6 Kit v3 | Aug 11, 2017 | Substantially Equivalent |
| K163347 | xTAG Cystic Fibrosis 39 Kit v2 | Dec 15, 2016 | Unknown |
| K163336 | xTAG Cystic Fibrosis 60 Kit v2, xTAG Data Analysis Software (TDAS) CFTR | Dec 15, 2016 | Unknown |