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 Description

The Francisella tularensis Real-time PCR Assay is composed of oligonucleotide primers and dual-labeled hydrolysis probes (Taqman®) for use in real-time PCR reactions. This assay is intended for the in vitro detection of Francisella tularensis in suspect infected persons with fever and other symptoms clinically compatible with acute tularemia. Extracted DNA samples are tested using the Francisella tularensis Real-time PCR Assay along with an extraction control primer and probe set to demonstrate adequate DNA extraction and isolation, specimen integrity, proper function of common reagents and equipment, and the absence of inhibitory substances.

AI/ML Overview

N/A

Summary

FDA 510(k) Clearance Letter - Francisella tularensis Real-time PCR Assay

Page 1

U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov

Doc ID # 04017.08.04

March 30, 2026

Centers for Disease Control and Prevention
Andita Clarke
Quality Assurance Specialist
1600 Clifton Road NE, MS:H24-2
Atlanta, GA 30329 USA

Re: K260812
Trade/Device Name: Francisella tularensis Real-time PCR Assay
Regulation Number: 21 CFR 866.4000
Regulation Name: Device To Detect And Identify Biothreat Microbial Agents In Human Clinical Specimens
Regulatory Class: Class II
Product Code: SGA
Dated: March 11, 2026
Received: March 13, 2026

Dear Andita Clarke:

We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

FDA's substantial equivalence determination also included the review and clearance of your Predetermined Change Control Plan (PCCP). Under section 515C(b)(1) of the Act, a new premarket notification is not required for a change to a device cleared under section 510(k) of the Act, if such change is consistent with an

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K260812 - Andita Clarke
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established PCCP granted pursuant to section 515C(b)(2) of the Act. Under 21 CFR 807.81(a)(3), a new premarket notification is required if there is a major change or modification in the intended use of a device, or if there is a change or modification in a device that could significantly affect the safety or effectiveness of the device, e.g., a significant change or modification in design, material, chemical composition, energy source, or manufacturing process. Accordingly, if deviations from the established PCCP result in a major change or modification in the intended use of the device, or result in a change or modification in the device that could significantly affect the safety or effectiveness of the device, then a new premarket notification would be required consistent with section 515C(b)(1) of the Act and 21 CFR 807.81(a)(3). Failure to submit such a premarket submission would constitute adulteration and misbranding under sections 501(f)(1)(B) and 502(o) of the Act, respectively.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality Management System Regulation (QMSR) (21 CFR Part 820), which includes, but is not limited to, ISO 13485 clause 7.3 (Design controls), ISO 13484 clause 8.3 (Nonconforming product), and ISO 13485 clause 8.5 (Corrective and preventative action). Please note that regardless of whether a change requires premarket review, the QMSR requires device manufacturers to review and approve changes to device design and production (ISO 13485 clause 7.3 and 21 CFR 820.70) and document changes and approvals in the Medical Device File (21 CFR 820.181).

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801 and Part 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the Quality Management System Regulation (QMSR) (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

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K260812 - Andita Clarke
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Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

BRYAN M. GRABIAS -S
2026.03.30 13:11:43
-04'00'

Bryan Grabias, Ph. D.
Acting Branch Chief
Bacterial Respiratory and Medical Countermeasures Branch
Division of Microbiology Devices
OHT7: Office of In Vitro Diagnostics
Office of Product Evaluation and Quality
Center for Devices and Radiological Health

Enclosure

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FORM FDA 3881 (8/23)
Page 1 of 1
PSC Publishing Services (301) 443-6740 EF

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120
Expiration Date: 07/31/2026
See PRA Statement below.

510(k) Number (if known): K260812

Device Name: Francisella tularensis Real-time PCR Assay

Indications for Use (Describe)

Use is limited to Centers for Disease Control and Prevention (CDC) designated laboratories.

Type of Use (Select one or both, as applicable)

☒ Prescription Use (Part 21 CFR 801 Subpart D)
☐ Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services
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"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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Centers for Disease Control and Prevention
Francisella tularensis Real-time PCR Assay
Special 510(k) Premarket Notification
Page 1 of 3

510(k) Summary

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92.

Assigned 510(k) number:

Submitted by: Centers for Disease Control and Prevention
1600 Clifton Road NE
Atlanta, GA 30329

Contact Person: Jasmine Chaitram, MPH
Acting Deputy Director for Readiness and Response
Office of Laboratory Systems and Response Centers for Disease Control and Prevention
(Registration number: 1050190)
1600 Clifton Road, NE, MS H24-12
Atlanta, GA 30329
(404) 498-1635 (office)
JChaitram@cdc.gov

Date prepared: March 12, 2026

Device trade name: Francisella tularensis Real-time PCR Assay

Classification name and regulation: (if applicable) Class II, 21 CFR 866.4000 Multiplex Nucleic Acid Detection System For Biothreat Agents

Product Code: SGA

Predicate device(s): Francisella tularensis Real-time PCR assay (K252072)

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Centers for Disease Control and Prevention
Francisella tularensis Real-time PCR Assay
Special 510(k) Premarket Notification
Page 2 of 3

Device Description

Assay Principle

The Francisella tularensis Real-time PCR Assay panel is based on real-time PCR technology used in many molecular diagnostic assays to date. The Francisella tularensis Real-time PCR Assay consists of Ft Pan1 and Ft Pan2 primer and probe sets designed for universal detection of Francisella tularensis bacteria. The assay also includes an additional control primer and probe set, RNase P (RP), which detects human RNase P to indicate adequate isolation of nucleic acid resulting from the extraction of the clinical specimen. A positive result in the RP assay indicates adequate specimen was present, ensures that common reagents and equipment are performing as expected and demonstrates the absence of inhibitory substances. A Human Specimen Control (HSC) is a noninfectious cultured human cell material that demonstrates successful recovery of DNA as well as extraction reagent integrity. The Ft Real-time PCR Positive DNA Control consists of a plasmid containing regions that are positive for both Ft Pan1 and Ft Pan2. The plasmid also contains a viral hemorrhagic septicemia virus (VHSV) gene for use as a contamination control. VHSV is a rhabdovirus that infects fish and is not pathogenic for humans and other animals.

Intended Use

The Francisella tularensis Real-time PCR Assay is an in vitro diagnostic test for the qualitative detection of chromosomal DNA sequences from Francisella 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 Francisella tularensis. Results generated from culture isolate testing are used as part of the Francisella tularensis Testing Algorithm. The diagnosis of Francisella tularensis infection must be made based on history, signs, symptoms, exposure likelihood, and other laboratory evidence, in addition to the identification of Francisella tularensis from culture isolates or from clinical specimens.

Use is limited to Centers for Disease Control and Prevention (CDC) designated laboratories.

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Centers for Disease Control and Prevention
Francisella tularensis Real-time PCR Assay
Special 510(k) Premarket Notification
Page 3 of 3

Technical Characteristics

The technological characteristics of the Francisella tularensis Real-time PCR Assay remains the same as the predicate device (K252072). This modification was made to update the Predetermined Change Control Plan (PCCP) for Modifications to the FDA-cleared CDC Francisella tularensis Real-time PCR Assay VER 01 only. No technological characteristics were changed.

Analytical Limit of Detection (LoD)

No analytical limit of detection testing was performed for this modification. The performance characteristics of the Francisella tularensis Real-time PCR Assay were previously established and remain the same as the predicate device (K252072). This modification was made to update the Predetermined Change Control Plan (PCCP) for Modifications to the FDA-cleared CDC Francisella tularensis Real-time PCR Assay VER 01 only. Inquiries regarding performance characteristics for the Francisella tularensis Real-time PCR Assay should be directed to the Centers for Disease Control and Prevention.

Analytical Sensitivity and Specificity

Inquiries regarding performance characteristics for the Francisella tularensis Real-time PCR Assay should be directed to the Centers for Disease Control and Prevention.

Clinical Performance

Inquiries regarding clinical performance characteristics for the Francisella tularensis Real-time PCR Assay should be directed to the Centers for Disease Control and Prevention.

Conclusion

The information submitted in this premarket notification that includes an update to the PCCP for modifications to the FDA-cleared Francisella tularensis Real-time PCR Assay is complete and supports a substantial equivalence determination to the predicate.

Regulation Number and Section

N/A