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510(k) K252072

Francisella tularensis Real-time PCR assay by Centers for Disease Control and Prevention — Product Code SGA

K252072 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 September 30, 2025. 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
September 30, 2025
Date Received
July 1, 2025
Clearance Type
Traditional
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 agent–associated nucleic acids in human clinical specimens.

Other clearances by Centers for Disease Control and Prevention

  • K260812 — Francisella tularensis Real-time PCR Assay (March 30, 2026)
  • K243274 — CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel: Influenza A/B Typin (July 11, 2025)
  • K243931 — CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel: Influenza A/B Typin (March 14, 2025)
  • K241110 — CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel, Influenza A Subtypi (May 21, 2024)
  • K222558 — Non-variola Orthopoxvirus Real-time PCR Primer and Probe Set (August 30, 2022)
  • K221834 — Non-variola Orthopoxvirus Real-time PCR Primer and Probe Set (June 24, 2022)
  • K221658 — Non-variola Orthopoxvirus Real-time PCR Primer and Probe Set (June 10, 2022)
  • K200370 — CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel, Influenza A/B Typin (March 10, 2020)
  • K192871 — B. anthracis Real-time PCR Assay (November 7, 2019)
  • K190302 — CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel, Influenza A/B Typin (March 27, 2019)

Other clearances for product code SGA

  • K260812 — Francisella tularensis Real-time PCR Assay (March 30, 2026)

FDA data resources