cobas Respiratory 4-flex for use on the cobas 5800/6800/8800 Systems
FDA 510(k) K243455 · Roche Molecular Systems, Inc.
Submission
- Device name
- cobas Respiratory 4-flex for use on the cobas 5800/6800/8800 Systems
- Applicant
- Roche Molecular Systems, Inc.
Pleasanton, CA, US - Received
- November 7, 2024
- Decision date
- July 31, 2025
- 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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Questions and answers
When was cobas Respiratory 4-flex for use on the cobas 5800/6800/8800 Systems cleared by the FDA?
cobas Respiratory 4-flex for use on the cobas 5800/6800/8800 Systems (K243455) received a 510(k) decision of Substantially Equivalent on July 31, 2025, 266 days after the submission was received.
What is the product code of K243455?
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.