The PAXgene® Blood DNA Tube is intended to collect, anticoagulate, stabilize, transport, and store a venous whole blood sample for preparation of human DNA for use with molecular diagnostic test methods that require DNA. The performance characteristics of this device have not been established for molecular diagnostic assays in general. Users must validate use of product for their specific molecular diagnostic assay.

Device Description

The PAXgene® Blood DNA Tube is a sterile, single use, plastic, evacuated blood collection tube with a BD Hemogard™ closure assembly (comprised of Hemogard™ stopper and shield components) and a measured quantity of K2EDTA additive quantity dispensed into each tube is designed to match the nominal blood draw volume of 2.5 mL. The tube is made of polyethylene terephthalate (PET) plastic which functions to maintain vacuum within the tube, allowing for accurate and consistent blood draw for the shelf life of the tube. A predetermined vacuum is drawn inside the tube that is sealed with a BD Hemogard™ closure which consists of a rubber stopper plus BD Hemogard™ shield.

The PAXgene® Blood DNA Tube is available as a 13 x 75 mm tube with a 2.5 mL nominal blood draw. The referenced first dimension represents the diameter of the tube, and the second dimension represents the length of the tube.

AI/ML Overview

This document is a 510(k) summary for the PAXgene® Blood DNA Tube (K231469), comparing it to a predicate device (K142821). The primary change in the subject device is a revised draw volume specification.

Here's the information regarding acceptance criteria and the supporting study, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Characteristic	Acceptance Criteria (Predicate Device K142821)	Reported Device Performance (Subject Device K231469)	Comparison
Draw Volume Specification	+10% to -19% of the labelled draw volume	+10% to -25% of the labelled draw volume	The difference extends the lower specification limit for blood draw volume of the PAXgene® Blood DNA Tube.

Note: The document explicitly states that all other characteristics (General Description, Indications for Use, Device Design, Device Materials, Packaging and Sterility) are identical between the subject and predicate devices. Therefore, the "acceptance criteria" for these would be identical to the predicate's specifications, and the "reported performance" of the subject device is stated to be identical.

2. Sample Size Used for the Test Set and Data Provenance

The document mentions "clinical evidence" and "shelf-life testing" to support the revised draw volume specification. However:

Specific sample sizes for the clinical study are NOT provided.
Data provenance (e.g., country of origin, retrospective or prospective) is NOT provided.

3. Number of Experts Used to Establish Ground Truth and Their Qualifications

This information is NOT provided in the document. The study appears to be a performance validation of a blood collection tube, not one requiring expert interpretation of diagnostic output.

4. Adjudication Method

This information is NOT applicable/not provided for this type of device validation study (a blood collection tube). Adjudication methods like 2+1 or 3+1 are typically used in studies involving expert interpretation of medical images or diagnostic results.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, an MRMC comparative effectiveness study was NOT done. This type of study is relevant for AI-assisted diagnostic devices where human readers' performance with and without AI assistance is compared. The PAXgene® Blood DNA Tube is a blood collection device, not an AI diagnostic.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

No, a standalone algorithm-only performance study was NOT done. This is not an AI diagnostic device. The performance validation is for the physical blood collection tube itself.

7. The Type of Ground Truth Used

The ground truth for the performance of the device (specifically regarding the revised draw volume specification) appears to be established through:

Clinical evidence: Implies direct measurement and analysis of blood DNA collected using the tubes.
Shelf-life testing: Verifies that the device maintains its performance over its specified shelf life, which includes its ability to draw the specified volume and preserve DNA quality.

8. The Sample Size for the Training Set

This information is NOT applicable/not provided. The device is a physical medical device (blood collection tube), not an AI algorithm that requires a training set.

9. How the Ground Truth for the Training Set Was Established

This information is NOT applicable. As it's not an AI device, there is no "training set" or ground truth established for training. The "ground truth" (or acceptable performance) for the device's function is established through the physical and chemical properties and laboratory performance testing.

Summary

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June 21, 2023

PreAnalytiX GmbH c/o Alexandra Kirby Staff Regulatory Affairs Specialist 1 Becton Drive Franklin Lakes, NJ 07417

Re: K231469

Trade/Device Name: PAXgene® Blood DNA Tube Regulation Number: 21 CFR 862.1675 Regulation Name: Blood Specimen Collection Device Regulatory Class: Class II Product Code: PJE Dated: May 22, 2023 Received: May 22, 2023

Dear Alexandra Kirby:

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 (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 located 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.

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 of medical device-related adverse events) (21 CFR

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for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-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 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 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-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/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-device-advice-comprehensive-regulatoryassistance/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.

Paula V. Caposino -S

Paula Caposino, Ph.D. Acting Deputy 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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Indications for Use

510(k) Number (if known) K231469

Device Name PAXgene® Blood DNA Tube

Indications for Use (Describe)

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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510(K) SUMMARY

PAXgene® Blood DNA Tube

510(k) Submission Number: K231469

Summary Preparation Date: June 20, 2023

Submitted by:

PreAnalytiX GmbH Garstligweg 8 Hombrechtikon, CH 8634

Contact:

Alexandra Kirby Staff Regulatory Affairs Specialist 1 Becton Drive, Franklin Lakes, NJ 07417 Email: Alexandra.Kirby@bd.com Phone: (862) 774-2318

Proprietary Names: PAXgene® Blood DNA Tube

Catalog Number: 761165

Common or Usual Names: Blood Collection Device

Regulatory Information

Classification Name: Blood Specimen Collection Device Classification Regulation: 21 CFR 862.1675 Regulatory Class: Class II Product Code: PJE Blood/Plasma Collection Device for DNA Testing Classification Panel: Clinical Chemistry

Predicate Device: K142821, PAXgene® Blood DNA Tube

Establishment Registration Information

Manufacturing/Sterilization Site:	Becton, Dickinson and CompanyBelliver Industrial Estates, Belliver Way, RoboroughPlymouth, PL6 &BP UKFDA Facility Registration Number: 9617032
Parent Company:	PreAnalytiX GmbHGarstligweg 8Hombrechtikon, CH 8634FDA Facility Registration Number: 3005202328

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Performance Standards:

1. EN ISO 13485:2016/A11:2021 Medical devices Quality management systems -Requirements for regulatory purposes
1. EN ISO 14971:2019/A11:2021 Medical Devices Application of risk management to medical devices
1. ISO 10993-1:2018 Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process
1. EN ISO 11137-1:2015/A2:2019 Sterilization of health care products Radiation Part 1: Requirements for development, validation, and routine control of a sterilization process for medical devices
1. EN ISO 11137-2:2015 Sterilization of health care products Radiation Part 2: Establishing the sterilization dose
1. EN ISO 11737-1:2018/A1:2021 Sterilization of health care products Microbiological methods - Part 1: Determination of a population of microorganisms on products
1. EN ISO 11737-2:2020 Sterilization of medical devices Microbiological methods Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process
1. EN 556-1:2001/AC:2006 Sterilization Of Medical Devices Requirements For Medical Devices To Be Designated "Sterile" - Part 1: Requirements For Terminally Sterilized Medical Devices
1. EN ISO 15223-1:2021 Medical devices Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirements
1. EN ISO 18113-1:2011 In vitro diagnostic medical devices Information supplied by the manufacturer (labelling) - Part 1: Terms. definitions and general requirements
1. EN ISO 18113-3:2011 In vitro diagnostic medical devices Information supplied by the manufacturer (labelling) - Part 3: In vitro diagnostic instruments for professional use
1. EN ISO 20417:2021 Medical devices Information to be supplied by the manufacturer
1. EN 62366-1:2015/AC:2016-09 Medical Devices Part 1: Application of usability engineering to medical devices
1. EN 13612:2002 Performance evaluation of in vitro diagnostic medical devices

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1. EN ISO 14001:2015 Environmental management systems Requirements with guidance for use
1. ISO 6710:2017 Single-use containers for venous blood specimen collection
1. EN 17141:2020 Cleanrooms and associated controlled environments. Biocontamination control
1. EN ISO 14644-1:2015 Cleanrooms and associated controlled environments Part 1: Classification of air cleanliness by particles concentration
1. EN ISO 14644-2:2015 Cleanrooms and associated controlled environments Part 2: Monitoring to provide evidence of cleanroom performance related to air cleanliness by particle concentration
1. ASTM D5276:2019 Standard Test Method for Drop Test of Loaded Containers by Free Fall
1. ASTM D4169:2016 Standard Practice for Performance Testing of Shipping Containers and Systems
1. ASTM D4728:2017 Standard Test Method for Random Vibration Testing of Shipping Containers
1. ASTM D999:2008 (R2015) Standard Test Methods for Vibration Testing of Shipping Containers

Indications for Use

The subject and predicate PAXgene® Blood DNA Tube share the same indications for use:

As both the subject and predicate devices have the same indications for use, this does not raise any new questions of safety or effectiveness.

Device Description

The subject PAXgene® Blood DNA Tube has the same device description, key design features, principles of operation, intended use, indications for use, product labeling, packaging, sterilization, shelf life, and performance characteristics as the predicate PAXgene® Blood DNA Tube cleared

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under K142821. The subject change of this special 510(k), a revised draw volume specification, does not alter these characteristics.

Substantial Equivalence

The subject and predicate device are substantially equivalent as described in Table 9.

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Characteristic	Subject DevicePAXgene® Blood DNA Tube	Predicate DevicePAXgene® Blood DNA TubeK142821	Comparison
GeneralDescription	The PAXgene® Blood DNATube is a sterile, single use,plastic, evacuated bloodcollection tube with a BDHemogard™ closure assemblyand a measured quantity ofK2EDTA additive. The additivequantity dispensed into eachtube is designed to match thenominal blood draw volume of2.5 mL. The tube is made ofpolyethylene terephthalate(PET) plastic which functions tomaintain vacuum within thetube, allowing for accurate andconsistent blood draw for theduration of the shelf life of thetube. A predetermined vacuumis drawn inside the tube that issealed with a BD Hemogard™closure which consists of arubber stopper plus BDHemogard™ shield.	The PAXgene® Blood DNATube is a sterile, single use,plastic, evacuated bloodcollection tube with a BDHemogard™ closure assemblyand a measured quantity ofK2EDTA additive. The additivequantity dispensed into eachtube is designed to match thenominal blood draw volume of2.5 mL. The tube is made ofpolyethylene terephthalate(PET) plastic which functions tomaintain vacuum within thetube, allowing for accurate andconsistent blood draw for theduration of the shelf life of thetube. A predetermined vacuumis drawn inside the tube that issealed with a BD Hemogard™closure which consists of arubber stopper plus BDHemogard™ shield.	Identical
Indications for Use	The PAXgene® Blood DNATube is intended to collect,anticoagulate, stabilize,transport, and store a venouswhole blood sample forpreparation of human DNA foruse with molecular diagnostictest methods that require DNA.The performance characteristicsof this device have not beenestablished for moleculardiagnostic assays in general.Users must validate use ofproduct for their specificmolecular diagnostic assay.	The PAXgene® Blood DNATube is intended to collect,anticoagulate, stabilize,transport, and store a venouswhole blood sample forpreparation of human DNA foruse with molecular diagnostictest methods that require DNA.The performance characteristicsof this device have not beenestablished for moleculardiagnostic assays in general.Users must validate use ofproduct for their specificmolecular diagnostic assay.	Identical
Device Design
Design/Function	Evacuated blood collection tube	Evacuated blood collection tube	Identical
Dimensions	13 mm x 75 mm	13 mm x 75 mm	Identical
Nominal DrawVolume	2.5 mL	2.5 mL	Identical
Closure	BD Hemogard™ closureconsisting of a rubber stopperplus BD Hemogard™ shield	BD Hemogard™ closureconsisting of a rubber stopperplus BD Hemogard™ shield	Identical
Characteristic	Subject DevicePAXgene® Blood DNA Tube	Predicate DevicePAXgene® Blood DNA TubeK142821	Comparison
Draw VolumeSpecification	+10% to -25% of the labelleddraw volume	+10% to -19% of the labelleddraw volume	The difference indraw volumespecificationextends the lowerspecification limitfor blood drawvolume of thePAXgene® BloodDNA Tube. Therevised drawvolumespecification for thesubject device,+10% to -25%, issupported byclinical evidenceand there are nonew questions ofsafety andeffectiveness.
Device Materials
Tube Material	Polyethylene terephthalate(PET)	Polyethylene terephthalate(PET)	Identical
Tube StopperLubricant	Silicone	Silicone	Identical
Anticoagulant	K2EDTA	K2EDTA	Identical
Injection molding(tube/HemogardTMclosure	Injection molded	Injection molded	Identical
Rubber molding(stopper)	Compression molded rubber	Compression molded rubber	Identical
Interior Coating	Spray coated/Dried	Spray coated/Dried	Identical
Evacuation	Vacuum chamber	Vacuum chamber	Identical
Packaging and Sterility
Tube Sterility	Sterile	Sterile	Identical
SterilizationMethod	Gamma irradiation	Gamma irradiation	Identical
Sterility AssuranceLevel (SAL)	10-6	10-6	Identical
Shelf Life	12 months	12 months	Identical
Shelf-Case/PackLevel	Shrink-wrapped expandedpolystyrene (EPS) tray	Shrink-wrapped expandedpolystyrene (EPS) tray	Identical

Table 9: PAXgene® Blood DNA Tube Substantial Equivalence Comparison

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PAXgene® Blood DNA Tube Special 510(k)

PreAnalytiX GmbH

As provided in Table 9, the subject PAXgene® Blood DNA Tube and the predicate PAXgene® Blood DNA Tube cleared under K142821 use the same operating principles, incorporate the same detailed designs, are manufactured from the same materials, are sterilized using the same method (gamma irradiation) with the same SAL of 10-6, use the same technological characteristics, have identical shelf lives (12 months), are packaged using the same shelf-case/pack and shipper/case materials, and have the same indications for use.

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The difference of the draw volume specification between the subject and predicate PAXgene® Blood DNA Tubes has been supported by clinical evidence and shelf-life testing, which do not raise different questions of safety and effectiveness.

Performance Testing - Bench Summary

Device testing was conducted to validate that the device performs as intended over the course of the product shelf life. Results of testing demonstrate acceptable performance.

Performance Testing - Animal Summary

No animal testing was conducted to support the change in draw volume specification for the subject devices.

Performance Testing - Clinical Summary

Clinical testing was conducted to validate that the device performs as intended. Results of the testing demonstrate acceptable performance.

Conclusion

In summary, the subject PAXgene® Blood DNA Tube is as safe and effective as the predicate PAXgene® Blood DNA Tube cleared under K142821. The subject PAXgene® Blood DNA Tube has the same indications for use, technological characteristics, and principles of operation as the predicate PAXgene® Blood DNA Tube cleared under K142821. The differences in draw volume specification between the subject and predicate PAXgene® Blood DNA Tubes do not raise new issues of safety or effectiveness. Bench and clinical testing demonstrate acceptable performance.

Based on information provided, the subject PAXgene® Blood DNA Tube is substantially equivalent to the predicate PAXgene® Blood DNA Tube cleared under K142821.

Regulation Number and Section

§ 862.1675 Blood specimen collection device.

(a)
Identification. A blood specimen collection device is a device intended for medical purposes to collect and to handle blood specimens and to separate serum from nonserum (cellular) components prior to further testing. This generic type device may include blood collection tubes, vials, systems, serum separators, blood collection trays, or vacuum sample tubes.(b)
Classification. Class II.