K252072 is an FDA 510(k) clearance for the Francisella tularensis Real-time PCR assay. This device is classified as a Biothreat Microbial Agent Nucleic Acid Detection Test (Class II - Special Controls, product code SGA).
Submitted by Centers For Disease Control and Prevention (Atlanta, US). The FDA issued a Cleared decision on September 30, 2025, 91 days after receiving the submission on July 1, 2025.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.4000. 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..
| 510(k) Number | K252072 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 01, 2025 |
| Decision Date | September 30, 2025 |
| Days to Decision | 91 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | Summary PDF |
| Product Code | SGA — Biothreat Microbial Agent Nucleic Acid Detection Test |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.4000 |
| Definition | 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. |