cobas Influenza A/B Nucleic acid test for use on the cobas Liat System, cobas Influenza A/B & RSV Nucleic acid test for use on the cobas Liat System, cobas Strep A Nucleic acid test for use on the cobas Liat System
FDA 510(k) K200065 · Roche Molecular Systems, Inc.
Submission
- Device name
- cobas Influenza A/B Nucleic acid test for use on the cobas Liat System, cobas Influenza A/B & RSV Nucleic acid test for use on the cobas Liat System, cobas Strep A Nucleic acid test for use on the cobas Liat System
- Applicant
- Roche Molecular Systems, Inc.
Pleasanton, CA, US - Received
- January 13, 2020
- Decision date
- February 10, 2020
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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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| K201505 | Simplexa Flu A/B & RSV Direct Gen II, Simplexa Flu A/B & RSV Positive Control PackOCC · Traditional | Diasorin Molecular, LLC | 08/22/2020SE |
| 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 |
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| K260047 | cobas Strep A Nucleic acid test for use on the cobas Liat System (07341911190); cobas…PGX · Traditional | 08/28/2026SE |
| K260045 | cobas® Cdiff Nucleic acid test for use on the cobas® Liat® System (07454945190); cobas®…OZN · Traditional | 08/28/2026SE |
| K260021 | cobas® BV/CVPQA · Traditional | 07/16/2026SE |
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| K252484 | cobas HCVMZP · Traditional | 11/03/2025SE |
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Questions and answers
When was cobas Influenza A/B Nucleic acid test for use on the cobas Liat System, cobas Influenza A/B & RSV Nucleic acid test for use on the cobas Liat System, cobas Strep A Nucleic acid test for use on the cobas Liat System cleared by the FDA?
cobas Influenza A/B Nucleic acid test for use on the cobas Liat System, cobas Influenza A/B & RSV Nucleic acid test for use on the cobas Liat System, cobas Strep A Nucleic acid test for use on the cobas Liat System (K200065) received a 510(k) decision of Substantially Equivalent on February 10, 2020, 28 days after the submission was received.
What is the product code of K200065?
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.