Francisella tularensis Real-time PCR Assay

K260812 · Centers for Disease Control and Prevention · SGA · Mar 30, 2026 · Immunology

Device Facts

• Record ID: K260812
• Device Name: Francisella tularensis Real-time PCR Assay
• Applicant: Centers for Disease Control and Prevention
• Product Code: SGA · Immunology
• Decision Date: Mar 30, 2026
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 866.4000
• Device Class: Class 2
• Attributes: PCCP

Indications for Use

The Francisella tularensis Real-time PCR Assay is an in vitro diagnostic test for the qualitative detection of chromosomal DNA sequences from F. tularensis. The assay can be used to test human whole blood EDTA, pleural fluid, and bacterial culture isolates grown on agar from individuals suspected of having tularemia. Results generated from direct specimen testing are presumptive for the identification of F. tularensis. Results generated from culture isolate testing are used as part of the LRN Francisella tularensis Testing Algorithm. The diagnosis of F. tularensis infection must be made based on history, signs, symptoms, exposure likelihood, and other laboratory evidence, in addition to the identification of F. tularensis from culture isolates or from clinical specimens. Negative results do not preclude infection with the biothreat microbial agents targeted by the device and should not be used as the sole basis for diagnosis, treatment, or other patient management decisions. Use is limited to Centers for Disease Control and Prevention (CDC) designated laboratories.

Device Story

In vitro diagnostic test; detects F. tularensis chromosomal DNA; uses real-time PCR technology; inputs include extracted DNA from human whole blood EDTA, pleural fluid, or bacterial culture isolates; utilizes Ft Pan1 and Ft Pan2 primer/probe sets for universal detection; includes RNase P control for specimen integrity and human DNA recovery; includes Human Specimen Control (HSC) and Positive DNA Control (plasmid with Ft Pan1/Pan2 and VHSV gene); used in CDC-designated laboratories by trained personnel; results from direct specimens are presumptive; results from culture isolates used in LRN testing algorithm; diagnosis requires clinical correlation (history, symptoms, exposure); negative results do not rule out infection.

Clinical Evidence

No clinical data provided; performance characteristics were previously established and remain identical to the predicate device (K252072).

Technological Characteristics

Real-time PCR assay; in vitro diagnostic; utilizes molecular amplification for detection of biothreat microbial agents. Modification pertains to instrument compatibility and sample type validation.

Indications for Use

Indicated for qualitative detection of F. tularensis chromosomal DNA in human whole blood EDTA, pleural fluid, and bacterial culture isolates from individuals suspected of having tularemia.

Regulatory Classification

Identification

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.

Submission Summary (Full Text)

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FDA U.S. FOOD & DRUG ADMINISTRATION

# SPECIAL 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY

## I Background Information:

A 510(k) Number

K260812

B Applicant

Centers for Disease Control and Prevention

C Proprietary and Established Names

Francisella tularensis Real-time PCR Assay

D Regulatory Information

| Product Code(s) | Classification | Regulation Section | Panel |
| --- | --- | --- | --- |
| SGA | Class II | 21 CFR 21 CFR 866.4000
- Device To Detect And Identify Biothreat Microbial Agents In Human Clinical Specimens | Microbiology |

## II Review Summary:

This 510(k) submission contains information/data on modifications made to the submitter's own class II device requiring 510(k). The following items are present and acceptable.

1. The name and 510(k) number of the SUBMITTER'S previously cleared device. (For a preamendments device, a statement to this effect has been provided.)
2. Submitter's statement that the INDICATIONS FOR USE/INTENDED USE of the modified device as described in its labeling HAS NOT CHANGED along with the proposed labeling which includes instructions for use, package labeling, and, if available, advertisements or promotional materials (labeling changes are permitted as long as they do not affect the intended use).

Food and Drug Administration

10903 New Hampshire Avenue

Silver Spring, MD 20993-0002

www.fda.gov

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3. A description of the device **MODIFICATION(S)**, including clearly labeled diagrams, engineering drawings, photographs, user's and/or service manuals in sufficient detail to demonstrate that the **FUNDAMENTAL SCIENTIFIC TECHNOLOGY** of the modified device has not changed. This change was to the authorized PCCP for the *Francisella tularensis* Real-time PCR Assay to modify the sample type(s) used in the clinical performance evaluation study conducted to support the addition of new real-time PCR instruments for use with the *Francisella tularensis* Real-time PCR Assay.

4. Comparison Information (i.e., similarities and differences) to the submitter's legally marketed predicate device including, labeling, intended use, and physical characteristics.

5. A Design Control Activities Summary which includes:

a) Identification of Risk Analysis method(s) used to assess the impact of the modification on the device and its components, and the results of the analysis.

b) Based on the Risk Analysis, an identification of the verification and/or validation activities required, including methods or tests used and acceptance criteria to be applied.

The labeling for this modified subject device has been reviewed to verify that the indication/intended use for the device is unaffected by the modification. In addition, the submitter's description of the particular modification(s) and the comparative information between the modified and unmodified devices demonstrate that the fundamental scientific technology has not changed. The submitter has provided the design control information as specified in The New 510(k) Paradigm and on this basis, I recommend the device be determined substantially equivalent to the previously cleared (or their preamendment) device.

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