Cell-Free DNA BCT

K231776 · Streck, Inc. · QMA · Jul 26, 2024 · Clinical Chemistry

Device Facts

• Record ID: K231776
• Device Name: Cell-Free DNA BCT
• Applicant: Streck, Inc.
• Product Code: QMA · Clinical Chemistry
• Decision Date: Jul 26, 2024
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1676
• Device Class: Class 2

Intended Use

Cell-Free DNA BCT is a direct-draw venous whole blood collection device intended for collection, stabilization, and transport of venous whole blood samples for use in conjunction with cell-free DNA next generation sequencing liquid biopsy assays that have been cleared or approved for use with samples collected in the Cell-Free DNA BCT device.

Device Story

Sterile, single-use, 10mL evacuated blood collection tube; contains K3EDTA anticoagulant and cell preservatives. Used by phlebotomists/clinicians for venous blood draw; tube inserted into holder/adapter; blood flows via vacuum; tube inverted 10 times for mixing. Preserves cfDNA integrity during transport to laboratory for plasma isolation and NGS liquid biopsy analysis. Enables standardized sample handling for specific NGS assays; ensures cfDNA stability for up to 8-10 days at room temperature, including shipping. Output is stabilized whole blood sample; clinical decision-making relies on downstream NGS assay results (e.g., Guardant Shield) for cancer detection/monitoring.

Clinical Evidence

Bench testing only. Evaluated cfDNA stability and variant call concordance using Guardant Shield assay. Studies included repeatability (n=59 healthy, n=29 CRC), lot-to-lot reproducibility, preservative interference, mixing variations, short-draw effects, shelf-life (up to 18 months), and shipping stability (including extreme temperature cycling). Concordance measured via Positive Percent Agreement (PPA) and Negative Percent Agreement (NPA). Results confirmed device maintains cfDNA integrity for downstream NGS analysis.

Technological Characteristics

Direct-draw venous whole blood collection tube; contains chemical stabilization agents to preserve cell-free DNA; vacuum-sealed for specific draw volume; non-sterile or sterile (as per standard blood collection tube manufacturing); standalone collection device.

Indications for Use

Indicated for collection, stabilization, and transport of venous whole blood samples for use with cleared/approved cell-free DNA next-generation sequencing liquid biopsy assays. Performance established only for Guardant360 CDx and Guardant Shield assays. Not for RNA, viral, or microbial nucleic acid stabilization; not for clinical chemistry assays; not for injection into patients.

Regulatory Classification

Identification

A blood collection device for cell-free nucleic acids is a device intended for medical purposes to collect, store, transport, and handle blood specimens and to stabilize and isolate cell-free nucleic acid components prior to further testing.

Special Controls

*Classification.* Class II (special controls). The special controls for this device are:(1) Design verification and validation documentation must include appropriate design inputs and design outputs that are essential for the proper functioning of the device for its intended use, including all of its indications for use, and must include the following: (i) Documentation demonstrating that appropriate, as determined by FDA, measures are in place ( *e.g.,* validated device design features and specifications) to ensure that users of blood collection device for cell-free nucleic acids devices are not exposed to undue risk of bloodborne pathogen exposure and operator injury during use of the device, including blood collection, transportation, and centrifugation processes.(ii) Documentation demonstrating that appropriate, as determined by FDA, measures are in place ( *e.g.,* validated device design features and specifications) to ensure that the device reproducibly and reliably collects, transports, stabilizes, and isolates cell-free nucleic acids of sufficient yield and quality suitable for downstream applications as appropriate for its intended use. At a minimum, these measures must include:(A) Data demonstrating that blood samples collected in the device have reproducible cell-free nucleic acid yields that are suitable, as determined by FDA, for downstream testing as appropriate for the intended use, including estimates of within-lot, within-device, and lot-to-lot variability; (B) Data demonstrating that cell-free nucleic acid yields isolated from blood specimens collected into the device do not add clinically significant bias to test results obtained using the downstream application(s) described in the intended use. For devices indicated for use with multiple downstream applications, data demonstrating acceptable performance for each type of claimed use or, alternatively, an appropriate, as determined by FDA, clinical justification for why such data are not needed; (C) Data demonstrating that the device appropriately stabilizes cell-free nucleic acids after sample collection, during storage, and during transport over the claimed shelf life of the device; (D) Data demonstrating that samples collected in the device have minimal levels of contamination with other types of nucleic acids present in cells or cellular components, and that these levels of contamination do not interfere with downstream testing; (E) Data from analytical or clinical studies that demonstrate that, when used as intended, the device consistently draws a blood sample volume that is within the indicated fill range; (F) Data from analytical or clinical studies that demonstrate that, when used as intended, cell-free nucleic acid yield, stability, and quality are not significantly impacted by interference due to other parts of the device (such as reduced or excess active ingredient) or specimen collection and processing procedures (such as hemolysis, centrifugation, or mixing of blood with anticoagulant or additives); and (G) Data from analytical studies that demonstrate that the device is suitable for its intended use across all storage and sample handling conditions described in the device labeling, including device shelf life and shipping conditions ( *e.g.,* temperature, humidity, duration).(iii) A protocol, reviewed and determined acceptable by FDA, that specifies the verification and validation activities that will be performed for anticipated device modifications to reevaluate performance claims or performance specifications. This protocol must include a process for assessing whether a modification to technology, engineering, performance, materials, specifications, or indications for use, or any combination thereof, could significantly affect the safety or effectiveness of the device. The protocol must include assessment metrics, acceptance criteria, and analytical methods for the performance testing of changes.

Submission Summary (Full Text)

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FDA U.S. FOOD & DRUG ADMINISTRATION

July 26, 2024

Streck, Inc.
Wendy Royalty
Director of Regulatory Affairs
7002 S. 109th Street
La Vista, Nebraska 68128

Re: K231776
Trade/Device Name: Cell-Free DNA BCT
Regulation Number: 21 CFR 862.1676
Regulation Name: Blood Collection Device For Cell-Free Nucleic Acids
Regulatory Class: Class II
Product Code: QMA
Dated: July 23, 2024
Received: July 24, 2024

Dear Wendy Royalty:

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.

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).

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

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K231776 - Wendy Royalty
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Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (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 systems (QS) regulation (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.

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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Marianela Perez-torres -S

Marianela Perez-Torres, Ph.D.
Division Director
Division of Chemistry and Toxicology Devices
OHT7: Office of In Vitro Diagnostics
Office of Product Evaluation and Quality
Center for Devices and Radiological Health

Enclosure

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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.

Submission Number (if known)
K231776

Device Name
Cell-Free DNA BCT

Indications for Use (Describe)
Cell-Free DNA BCT is a direct-draw venous whole blood collection device intended for collection, stabilization, and transport of venous whole blood samples for use in conjunction with cell-free DNA next generation sequencing liquid biopsy assays that have been cleared or approved for use with samples collected in the Cell-Free DNA BCT device.

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)

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