Cleared Traditional

Francisella tularensis Real-time PCR assay

K252072 · Centers For Disease Control and Prevention · Microbiology

Sep 2025

Decision

91d

Days

Class 2

Risk

About This 510(k) Submission

K252072 is an FDA 510(k) clearance for the Francisella tularensis Real-time PCR assay, 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 review panel. Regulated under 21 CFR 866.4000.

Submission Details

510(k) Number	K252072 FDA.gov
FDA Decision	Cleared 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

Device Classification

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 Agent?associated Nucleic Acids In Human Clinical Specimens.