The BD Vacutainer® Citrate Blood Collection Tube (0.109M buffered sodium citrate) is a sterile, single use tube used for the collection, containment, transport, and centrifugation of venous blood specimens to obtain plasma for in vitro diagnostic testing. It is used in settings where a venous blood sample is collected by a trained healthcare worker. The BD Vacutainer® Citrate Blood Collection Tube is used for clinical laboratory testing in coagulation.

Device Description

BD Vacutainer® Citrate Blood Collection Tubes (BD Citrate Tubes) are available in plastic configurations and contain a liquid additive. Tubes include a color-coded BD Hemogard™ Closure and are comprised of an inner and outer tube to maintain the draw volume and liquid additive. Refer to Table 1 for unique product configurations. Tube stoppers are lubricated with silicone to facilitate stopper insertion. The buffered sodium citrate solution provides an anticoagulated specimen when used in accordance with the instructions for use. The tubes are compatible with the BD Vacutainer® Blood Collection Needles, Blood Collection Sets, Transfer Devices. Holders and Adaptors.

AI/ML Overview

The information provided in the document describes the substantial equivalence of the "BD Vacutainer Citrate Blood Collection Tubes" to a predicate device, focusing on physical and chemical characteristics, rather than the performance of an AI or software device. As such, many of the requested categories for AI/software device evaluation (e.g., sample size of test set, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, training set sample size, how ground truth for training set was established) are not applicable to this submission.

However, I can extract information related to the device's performance testing and acceptance criteria as described for the medical device itself.

1. Table of Acceptance Criteria and Reported Device Performance

The document lists "Non-Clinical Performance Testing Results" in Table 3, which can be interpreted as demonstrating the device's adherence to its design specifications or performance criteria. The acceptance criteria themselves are not explicitly detailed in the provided text (e.g., what constitutes a "Pass" for "Draw Volume" or "Resistance to Breakage"). However, the results consistently report "Pass."

Test	Acceptance Criteria (Implied)	Reported Device Performance
Draw Volume	Met specifications (e.g., 2.7 ± 10% mL or 1.8 ± 10% mL)	Pass
X-Value	Met specified requirements	Pass
Second Stopper Pullout	Met specified requirements for stopper integrity	Pass
Stopper/Shield Separation	Met specified requirements for separation integrity	Pass
Stopper Leakage	Met specified requirements for preventing leakage	Pass
Resistance to Breakage during Drop Testing	Met specified requirements for impact resistance	Pass
Resistance to Breakage During Centrifugation	Met specified requirements for integrity during centrifugation	Pass
Moisture Lost	Met specified limits for moisture loss over time	Pass
Ship Testing for Functional Performance of Packaging Materials	Met specified requirements for packaging integrity during transport	Pass

Clinical Performance Studies and Acceptance Criteria (as described):

The clinical studies aimed to demonstrate "Clinical Equivalence" and evaluated specific parameters. The acceptance criteria for these (e.g., non-inferiority margins) are not explicitly stated but are implied by the "demonstrated clinical equivalence" and "passed non-inferiority criterion" statements.

Study	Key Objective / Acceptance Criteria (Implied)	Reported Device Performance
Clinical Equivalence	Evaluate clinical equivalence of BD Citrate Tubes compared to a similar comparator citrate tube for PT, aPTT, INR, D-Dimer, Anti-Factor Xa. (Implied acceptance: demonstrating equivalence, likely within predefined statistical margins).	Clinical equivalence was demonstrated for all tube comparisons for representative selected plasma coagulation test parameters (PT, aPTT, INR, D-Dimer, Anti-Factor Xa).
Within-Tube Stability (WTS)	Demonstrate within-tube stability for PT, aPTT, INR, D-Dimer, Anti-Factor Xa with BD Citrate Tubes. (Implied acceptance: stability within predefined limits over a specified time).	Demonstrated Within-Tube Stability (WTS) for representative selected plasma coagulation test parameters (PT, aPTT, INR, D-Dimer, Anti-Factor Xa).
Shelf-Life Performance	Evaluate performance of BD Citrate Tubes at end-of-shelf-life (EOSL) compared to recently manufactured tubes for PT, aPTT, INR, D-Dimer, Anti-Factor Xa. (Implied acceptance: performance at EOSL is comparable to fresh tubes, supporting the proposed shelf-life).	The results support the proposed shelf-life for the selected plasma coagulation test parameters (PT, aPTT, INR, D-Dimer, Anti-Factor Xa).
Repeatability/Reproducibility	Evaluate within-tube repeatability (duplicate testing), tube-to-tube reproducibility (two tubes/lot), and lot-to-lot reproducibility (three lots) for PT, aPTT, INR, D-Dimer, Anti-Factor Xa, compared to a similar comparator. (Implied acceptance: meeting non-inferiority criterion based on ratios appropriate to data structure).	The evaluation passed the non-inferiority criterion for all tube comparisons, based on the ratios appropriate to the data structure for the selected coagulation analytes when compared with a similar comparator citrate anticoagulant tube (PT, aPTT, INR, D-Dimer, Anti-Factor Xa).

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

The document does not explicitly state the sample sizes for the clinical test sets. It mentions "whole blood collected," but the number of subjects or samples is not specified.

Data Provenance: "Clinical testing was conducted on whole blood collected in the subject device, BD Citrate Tubes, and a similar comparator tube." This implies the data were collected from human subjects, likely in a clinical setting. The country of origin is not specified, and it's a prospective collection for these studies as they were performed to demonstrate equivalence.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not applicable. The device is a blood collection tube, not an AI diagnostic system requiring expert interpretation of primary data (like medical images). The "ground truth" for clinical performance likely refers to the analytical results obtained from the blood samples, which are objectively measured by laboratory instruments.

4. Adjudication Method for the Test Set

This information is not applicable for a device of this nature. Adjudication methods are typically relevant for subjective interpretations (e.g., by human readers in medical imaging studies).

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This is not applicable as the device is a blood collection tube, not an AI or software device that assists human readers.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

This is not applicable as the device is a blood collection tube, not an algorithm or AI system.

7. The Type of Ground Truth Used

For the clinical studies, the "ground truth" refers to the analytical measurements of coagulation parameters (Prothrombin Time [PT], Activated Partial Thromboplastin Time [aPTT], International Normalized Ratio [INR], D-Dimer, Anti-Factor Xa) obtained from the blood plasma after collection and processing. These are objective laboratory measurements, not expert consensus, pathology, or outcomes data in the typical sense for AI devices.

8. The Sample Size for the Training Set

This is not applicable as the device is not an AI/machine learning device that requires a training set.

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

This is not applicable as the device is not an AI/machine learning device that requires a training set.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

October 31, 2024

Becton Dickinson and Company Joseph Basore Staff Regulatory Affairs Specialist 1 Becton Drive Franklin Lakes, New Jersey 07417

Re: K240455

Trade/Device Name: BD Vacutainer Citrate Blood Collection Tubes Regulation Number: 21 CFR 862.1675 Regulation Name: Blood Specimen Collection Device Regulatory Class: Class II Product Code: GIM Dated: February 15, 2024 Received: October 1, 2024

Dear Joseph Basore:

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"

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(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 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 OS 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 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-safetyreporting-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.

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 Rue"). 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-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

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-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).

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Sincerely,

Image /page/2/Picture/3 description: The image shows the text "Min Wu-SA" in a large, sans-serif font. The text is black and the background is white. The letters are evenly spaced and the text is easy to read. There is a watermark in the background.

Min Wu, Ph.D. Branch Chief Division of Immunology and Hematology 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) K240455

Device Name

BD Vacutainer® Citrate Blood Collection Tubes

Indications for Use (Describe)

The BD Vacutainer® Citrate Blood Collection Tube (0.109M buffered sodium citrate) is a sterile, single used for the collection, containment, transport, and centrifygation of venous blood specimens to in vitro diagnostic testing. It is used in settings where a venous blood sample is collected by a trained healthcare worker. The BD Vacutainer® Citrate Blood Collection Tube is used for clinical laboratory testing in coagulation.

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 1

1.1 Device Name

BD Vacutainer® Citrate Blood Collection Tubes

1.2 Summary Preparation Date:

Date: February 15, 2024

Submitted by: 1.3

Becton, Dickinson and Company 1 Becton Drive Franklin Lakes, NJ 07417-1885

Phone: (201) 847-6800

1.4 Contact:

Joseph Basore, Ph.D., RAC Staff Regulatory Affairs Specialist email: Joseph.Basore@bd.com

Phone: (616) 301-4068

1.5 Alternate Contact:

Nate Carrington VP, Regulatory Affairs email: Nate.Carrington@bd.com

Phone: (317) 645-5190

1.6 Proprietary Name:

BD Vacutainer® Citrate Blood Collection Tubes

1.7 Common or Usual Names:

BD Citrate Tube

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BD Vacutainer® Citrate Blood Collection Tubes 510(k)

Integrated Diagnostic Solutions-Specimen Management Becton, Dickinson and Company

1.8 Regulatory Information

Classification Name: Tubes, Vacuum Sample, With Anticoagulant Classification Regulation: 21 CFR § 862.1675 Regulatory Class: Class II Product Code: GIM

1.9 Predicate Device

BD Vacutainer Safety Coagulation Tube (K013971)

Device Establishment 1.10

Becton, Dickinson and Company

1.11 Registration Number:

2243072

Performance Standards: 1.12

ANSI AAMI ISO 11137-1:2006/(R)2015 Sterilization of health care products - Radiation - Part 1: Requirements for development, validation, and routine control of a sterilization process for medical devices [Including: Amendment 1 (2013) and Amendment 2 (2019)].

ANSI AAMI ISO 11137-2:2013/(R)2019 Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose.

ANSI/AAMI/ISO 11137-3:2017 Sterilization of health care products - Radiation - Part 3: Guidance on dosimetric aspects of development, validation and routine control.

ANSI/AAMI/ISO 11737-1:2018 Sterilization of health care products - Microbiological methods - Part 1: Determination of a population of microrganisms on products.

ANSI/AAMI/ISO 11737-2:2019 Sterilization of medical devices - Microbiological methods -Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process.

ANSI AAMI ST67:2019 Sterilization of health care products - Requirements and guidance for selecting a sterility assurance level (SAL) for products labeled "sterile".

ASTM D4169-16 Standard Practice for Performance Testing of Shipping Containers and Systems.

EN ISO 14971:2019 Medical Devices – Application of risk management to medical devices.

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1.13 Indications for Use

1.14 Device Description

Catalog #	Size(diameter xlength inmm)	DrawVolume(mL)	Closure Assembly	Material(Inner/Outer)	Additive	Shelf Life
363083		2.7 ± 10%(2.43 -2.97)	BD Hemogard™(Light Blue) andStopper (Light Blue)		0.109 M (3.2%)Buffered SodiumCitrate	9 months
366560	13 x 75			Polypropylene/PolyethyleneTerephthalate(PET)
363080		1.8 ± 10%(1.62 -1.98)	BD Hemogard™(Translucent) andStopper (Light Blue)			6 months

Table 1: BD Citrate Tubes Configurations

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Substantial Equivalence 1.15

The subject and predicate device are substantially equivalent as described in Table 2.

Table 2: Substantial Equivalence Comparison

Characteristic	Subject Device: BD Vacutainer® CitrateBlood Collection Tubes	Predicate Device: BD Vacutainer® SafetyCoagulation Tube(K013971)	Comments
Indications for use	The BD Vacutainer® Citrate BloodCollection Tube (0.109M buffered sodiumcitrate) is a sterile, single use tube used forthe collection, containment, transport, andcentrifugation of venous blood specimens toobtain plasma for in vitro diagnostic testing.It is used in settings where a venous bloodsample is collected by a trained healthcareworker. The BD Vacutainer® Citrate BloodCollection Tube is used for clinicallaboratory testing in coagulation.	BD Vacutainer® Safety Coagulation tube is aplastic evacuated blood collection tube thatprovides a means of collecting, transporting andprocessing blood in a closed tube. The bufferedsodium citrate additive provides an anticoagulatedspecimen that may be used for clinical laboratorycoagulation assays. The benefits of a safety plasticcoagulation tube with Hemogard™ Safety ClosureAssembly are:• Reduced risk of specimen tube breakage• Reduced exposure to blood by laboratorypersonnel and to minimize blood splatter duringstopper removal.These benefits lead to increased safety of laboratorypersonnel and reduced necessity of repeat specimencollection.	There are minor changes to theindications for use wording tobest align with the appropriateuse of the product and availabletesting. The benefits/safetystatements for use of plastictubes over glass tubes have beenremoved. These changes do notresult in a new intended use forthe subject device.
Product Code	GIM (Tubes, Vacuum Sample, WithAnticoagulant)	JKA (Tubes, Vials, Systems, Serum Separators,Blood Collection)	GIM indicates the use of ananticoagulant and so is moreappropriate to describe the BDCitrate Tubes.
Regulation	21 C.F.R. § 862.1675	21 C.F.R. § 862.1675	Identical
IntendedPopulation	General Use – all populations	General Use – all populations	Identical
Evacuated BloodCollection Tube	Yes	Yes	Identical
Clot/Anticoagulation	Anti-coagulation	Anti-coagulation	Identical
Characteristic	Subject Device: BD Vacutainer® CitrateBlood Collection Tubes	Predicate Device: BD Vacutainer® SafetyCoagulation Tube(K013971)	Comments
Tube Material	Plastic inner and outer tubes	Plastic inner and outer tubes	Equivalent; the product hasundergone like for like changesin some materials since theinitial FDA clearance in 2001.These differences do not raisedifferent questions of safety oreffectiveness.
Tube Size	13 x 75 mm	13 x 75 mm	Identical
Draw Volume	1.8 mL or 2.7 mL	1.8 mL or 2.7 mL	Identical
Blood to AdditiveRatio	9 to 1	9 to 1	Identical
Additive	0.109M (3.2%) sodium citrate	0.109M (3.2%) sodium citrate	Identical
Closure Type/Color	2.7mL: Hemogard™ light blue cap and bluestopper1.8mL: Hemogard™ Translucent cap andblue stopper	2.7mL: Hemogard™ light blue cap and blue stopper1.8mL: Hemogard™ Translucent cap and bluestopper	Equivalent; the product hasundergone like for like changesin some materials since theinitial FDA clearance in 2001.These differences do not raisedifferent questions of safety oreffectiveness.
Tube Evacuation	Vacuum Chamber	Vacuum Chamber	Identical
Sterilization Method	Gamma Irradiation	Gamma Irradiation	Identical
Sterility AssuranceLevel (SAL)	10-3	10-3	Identical
Shelf Life	2.7 mL: 9 months1.8 mL: 6 months	2.7 mL: 9 months1.8 mL: 6 months	Identical

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BD Vacutainer® Citrate Blood Collection Tubes 510(k)

Integrated Diagnostic Solutions-Specimen Management

Becton, Dickinson and Company

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1.16 Substantial Equivalence Discussion

Intended Use/Indications for Use

The BD Vacutainer® Citrate Blood Collection Tubes includes the same intended use of evacuated blood containers for collection, separation, processing and storage of venous blood as the predicate device (K013971). The proposed indications for use statement is the same as the prior indications for use statement with slightly different wording to best align with the appropriate use of the product and therefore does not result in a new intended use.

As with the predicate device the subject device will be used for all patient populations in settings where a venous sample is collected by a trained healthcare worker. Therefore, using K013971 as the predicate satisfies the FDA's requirements regarding intended use.

Technological Characteristics

Both the subject and predicate tubes cleared under K013971 use 0.109M buffered sodium citrate anticoagulant to reversibly bind free calcium in the blood and stop the clotting/coagulation cascade. Both the subject and predicate device are comprised of a plastic outer tube and plastic inner tube that helps retain vacuum and enables the different variants of the tubes to be consistent in outer dimension (13 x 75 mm). while having different draw volumes of 1.8 mL and 2.7 mL. Lastly, both the subject and predicate tubes utilize a Hemogard™ Closure Assembly with a rubber stopper and protective plastic shield to reduce user exposure to blood.

Since the clearance of the predicate K013971, there were additional minor changes that individually did not require a new 510(k) submission nor introduce new/modified existing risks, but which have been determined to cumulatively warrant submission of this new 510(k). Changes broadly included label/packaging updates, qualification of additional material suppliers, material discontinuation/replacement/location changes, new/changed manufacturing sites/equipment/processing, minor specification updates, supplier changes, etc. Therefore, the cumulative effect of all changes together has the potential to cause technological differences between the subject and predicate tubes that were addressed through performance testing. These technological differences do not raise new questions of safety and effectiveness and were not made with the intent to improve the safety and or effectiveness of the device.

1.17 Performance Testing - Bench Summary

Non-clinical performance testing was conducted following defined protocols and with established acceptance criteria to evaluate the following attributes of the BD Vacutainer® Citrate Blood Collection Tubes at time-zero and over the proposed shelf life:

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Test	Results
Draw Volume	Pass
X-Value	Pass
Second Stopper Pullout	Pass
Stopper/Shield Separation	Pass
Stopper Leakage	Pass
Resistance to Breakage during Drop Testing	Pass
Resistance to Breakage During Centrifugation	Pass
Moisture Lost	Pass
Ship Testing for Functional Performance of Packaging Materials	Pass

Table 3: Non-Clinical Performance Testing Results

The BD Vacutainer® Citrate Blood Collection Tubes met all non-clinical testing requirements at time-zero and over the product shelf life, demonstrating that the device functions as designed. Therefore, these performance tests demonstrate substantial equivalence of the subject devices to the predicate devices.

Performance Testing - Clinical Summary 1.18

Clinical testing was conducted on whole blood collected in the subject device, BD Citrate Tubes, and a similar comparator tube to demonstrate Clinical Equivalence. Additional clinical testing was completed to evaluate Within-Tube Stability. Shelf-Life Performance, and Repeatability/Reproducibility. Clinical testing results confirmed the devices' clinical equivalence for coagulation parameters. A summary of the clinical studies completed is included below:

Clinical Equivalence and Within-Tube Stability: The purpose of these studies was to ● evaluate the Clinical Equivalence of the BD Citrate Tubes in comparison with a similar comparator citrate tube, and to demonstrate Within-Tube Stability (WTS), for representative selected plasma coagulation test parameters (i.e., Prothrombin Time [PT], Activated Partial Thromboplastin Time [aPTT], International Normalized Ratio [INR], D-Dimer, Anti-Factor Xa). Clinical equivalence was demonstrated for all tube comparisons.
Shelf-Life: This study evaluated the performance of BD Citrate Tubes at the end of shelf-● life (EOSL) in comparison with BD Citrate Tubes that were recently manufactured for selected plasma coagulation test parameters (i.e., Prothrombin Time [PT], Activated Partial Thromboplastin Time [aPTT], International Normalized Ratio [INR], D-Dimer, Anti-Factor Xa). The results support the proposed shelf-life for the selected plasma coagulation test parameters.

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Repeatability/Reproducibility: This study evaluated the performance of BD Citrate ● Tubes in comparison to a similar comparator citrate anticoagulant tube for within tube repeatability (by testing tubes in duplicate), tube to tube reproducibility (by testing two tubes within each lot) and lot to lot reproducibility (by testing three lots of tubes) for selected plasma coagulation test parameters (i.e., Prothrombin Time [PT], Activated Partial Thromboplastin Time [aPTT]. International Normalized Ratio [INR], D-Dimer, Anti-Factor Xa). The evaluation passed the non-inferiority criterion for all tube comparisons, based on the ratios appropriate to the data structure for the selected coagulation analytes when compared with a similar comparator citrate anticoagulant tube.

1.19 Conclusion

The known differences between the BD Vacutainer® Citrate Blood Collection Tubes (subject device) and predicate device have been identified and the rationale to support substantial equivalence has been provided. The proposed subject device and predicate device have the same intended use, principle of operation, and technological characteristics. Non-Clinical and Clinical Performance testing demonstrates that the subject device meets applicable performance requirements. Therefore, the differences between the subject device and the predicate device do not raise different questions of safety and effectiveness. In conclusion, the subject device is substantially equivalent to the predicate device.

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.