Cleared Traditional

K252072 - Francisella tularensis Real-time PCR assay (FDA 510(k) Clearance)

Class II Microbiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K252072 · Centers For Disease Control and Prevention · Microbiology device
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Sep 2025
Decision
91d
Days
Class 2
Risk

K252072 is an FDA 510(k) clearance for the Francisella tularensis Real-time PCR assay. Classified as Biothreat Microbial Agent Nucleic Acid Detection Test (product code SGA), Class II - Special Controls.

Submitted by Centers For Disease Control and Prevention (Atlanta, US). The FDA issued a Cleared decision on September 30, 2025 after a review of 91 days - within the typical 510(k) review window.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.4000 - the FDA microbiology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Microbiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Centers For Disease Control and Prevention devices

Submission Details

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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized Yes - Predetermined Change Control Plan authorized FDA has pre-authorized specific future modifications to this device, a pathway common in AI/SaMD devices.
Regulatory Context
Review time vs. panel average
11d faster than avg
Panel avg: 102d · This submission: 91d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. PCCP authorized - AI/SaMD pathway.

Device Classification

Product Code SGA Biothreat Microbial Agent Nucleic Acid Detection Test
Device Class Class 2 - 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.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Microbiology devices follow this clearance model.