510(k) K260812
K260812 is an FDA 510(k) premarket notification submitted by Centers for Disease Control and Prevention for the device "Francisella tularensis Real-time PCR Assay". The FDA issued a decision of Substantially Equivalent on March 30, 2026. The device falls under product code SGA (Biothreat Microbial Agent Nucleic Acid Detection Test), a Class II device regulated under 21 CFR 866.4000. Centers for Disease Control and Prevention has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 30, 2026
- Date Received
- March 13, 2026
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Biothreat Microbial Agent Nucleic Acid Detection Test
- Device Class
- Class II
- Regulation Number
- 866.4000
- Review Panel
- MI
- Submission Type
A biothreat microbial agent nucleic acid detection test is a qualitative in vitro diagnostic device for the detection and identification of biothreat microbial agentassociated nucleic acids in human clinical specimens.