BioCode® Respiratory Pathogen Panel (RPP)
FDA 510(k) K254139 · Applied BioCode, Inc.
Submission
- Device name
- BioCode® Respiratory Pathogen Panel (RPP)
- Applicant
- Applied BioCode, Inc.
Santa Fe Springs, CA, US - Received
- December 22, 2025
- Decision date
- May 1, 2026
- 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…
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|---|---|---|---|
| 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 |
| 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 |
| 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 |
|---|---|---|
| K242877 | BioCode Gastrointestinal Pathogen Panel (GPP)PCH · Traditional | 01/10/2025SE |
| K192485 | BioCode Respiratory Pathogen Panel (RPP)OCC · Traditional | 12/23/2019SE |
| K190585 | Biocode Gastrointestinal Pathogen Panel (GPP)PCH · Traditional | 06/05/2019SE |
| K180041 | BioCode Gastrointestinal Pathogen Panel (GPP)PCH · Traditional | 09/28/2018SE |
Questions and answers
When was BioCode® Respiratory Pathogen Panel (RPP) cleared by the FDA?
BioCode® Respiratory Pathogen Panel (RPP) (K254139) received a 510(k) decision of Substantially Equivalent on May 1, 2026, 130 days after the submission was received.
What is the product code of K254139?
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.