Francisella tularensis Real-time PCR assay
FDA 510(k) K252072 · Centers for Disease Control and Prevention
510(k) numberK252072
Submission
- Device name
- Francisella tularensis Real-time PCR assay
- Applicant
- Centers for Disease Control and Prevention
Atlanta, GA, US - Received
- July 1, 2025
- Decision date
- September 30, 2025
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- SGA – Biothreat Microbial Agent Nucleic Acid Detection Test
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.4000
- Specialty
- Immunology
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.
Other 510(k)s with product code SGA
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K260812 | Francisella tularensis Real-time PCR AssaySGA · Special | Centers for Disease Control and Prevention | 03/30/2026SE |
More from Centers for Disease Control and Prevention
| 510(k) | Device | Decision |
|---|---|---|
| K260812 | Francisella tularensis Real-time PCR AssaySGA · Special | 03/30/2026SE |
| K243274 | CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel: Influenza A/B Typing Kit…OZE · Traditional | 07/11/2025SE |
| K243931 | CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel: Influenza A/B Typing Kit…OZE · Traditional | 03/14/2025SE |
| K241110 | CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel, Influenza A Subtyping Kit…OZE · Special | 05/21/2024SE |
| K222558 | Non-variola Orthopoxvirus Real-time PCR Primer and Probe SetPBK · Special | 08/30/2022SE |
| K221834 | Non-variola Orthopoxvirus Real-time PCR Primer and Probe SetPBK · Special | 06/24/2022SE |
| K221658 | Non-variola Orthopoxvirus Real-time PCR Primer and Probe SetPBK · Traditional | 06/10/2022SE |
| K200370 | CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel, Influenza A/B Typing Kit…OZE · Special | 03/10/2020SE |
| K192871 | B. anthracis Real-time PCR AssayNHT · Special | 11/07/2019SE |
| K190302 | CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel, Influenza A/B Typing Kit…OZE · Traditional | 03/27/2019SE |
Questions and answers
When was Francisella tularensis Real-time PCR assay cleared by the FDA?
Francisella tularensis Real-time PCR assay (K252072) received a 510(k) decision of Substantially Equivalent on September 30, 2025, 91 days after the submission was received.
What is the product code of K252072?
The FDA product code is SGA – Biothreat Microbial Agent Nucleic Acid Detection Test, a Class II (moderate risk) device regulated under 21 CFR 866.4000.