510(k) K261362
K261362 is an FDA 510(k) premarket notification submitted by Cepheid for the device "Xpert Hemorrhagic Fever". The FDA issued a decision of Substantially Equivalent on August 7, 2026. The device falls under product code QVR (Multiplex Nucleic Acid Detection System For Biothreat Agents), a Class II device regulated under 21 CFR 866.4000. Cepheid has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 7, 2026
- Date Received
- April 27, 2026
- Clearance Type
- Dual Track
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Multiplex Nucleic Acid Detection System For Biothreat Agents
- Device Class
- Class II
- Regulation Number
- 866.4000
- Review Panel
- MI
- Submission Type
A multiplex nucleic acid detection system for biothreat agents is a qualitative in vitro diagnostic test for detection and identification of nucleic acids from biothreat pathogens in human clinical specimens