(259 days)
Not Found
No
The device is a blood collection tube and the summary describes its physical characteristics and performance in collecting and preserving blood for laboratory testing. There is no mention of any computational analysis or algorithms, let alone AI/ML.
No
The device is described as a blood collection tube used for in vitro diagnostic testing, specifically for obtaining plasma for clinical laboratory testing in coagulation. It is not intended to treat or ameliorate a disease or condition in a patient.
No
Explanation: The device is a blood collection tube used to obtain plasma for in vitro diagnostic testing. It is a tool for collecting samples, not for performing the diagnostic test itself. The document explicitly states "It is used for clinical laboratory testing in coagulation," indicating its role as a pre-analytical device rather than a diagnostic device.
No
The device is a physical blood collection tube with liquid additive, not software. The description details hardware components and physical testing.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states that the tube is used "to obtain plasma for in vitro diagnostic testing." It also mentions its use for "clinical laboratory testing in coagulation."
- Device Description: The description details a component (buffered sodium citrate solution) that provides an anticoagulated specimen, which is necessary for certain in vitro diagnostic tests (specifically coagulation tests).
- Performance Studies: The "Summary of Performance Studies" describes clinical testing conducted to evaluate the device's performance for "selected plasma coagulation test parameters," which are in vitro diagnostic tests.
The device is designed to collect and prepare a sample (plasma) that will be used in a laboratory setting for diagnostic testing performed outside of the body (in vitro).
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
GIM
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
General Use – all populations
Intended User / Care Setting
It is used in settings where a venous blood sample is collected by a trained healthcare worker.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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:
- 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
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.
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.
- 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.
- 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
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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"
1
(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).
2
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
3
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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4
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
5
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.
6
1.13 Indications for Use
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.
1.14 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.
| Catalog # | Size
(diameter x
length in
mm) | Draw
Volume
(mL) | Closure Assembly | Material
(Inner/Outer) | Additive | Shelf Life |
|-----------|-----------------------------------------|---------------------------|-----------------------------------------------------------|----------------------------------------------------------|----------------------------------------------|------------|
| 363083 | | 2.7 ± 10%
(2.43 -2.97) | BD Hemogard™
(Light Blue) and
Stopper (Light Blue) | | 0.109 M (3.2%)
Buffered Sodium
Citrate | 9 months |
| 366560 | 13 x 75 | | | Polypropylene/
Polyethylene
Terephthalate
(PET) | | |
| 363080 | | 1.8 ± 10%
(1.62 -1.98) | BD Hemogard™
(Translucent) and
Stopper (Light Blue) | | | 6 months |
Table 1: BD Citrate Tubes Configurations
7
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® Citrate
Blood Collection Tubes | Predicate Device: BD Vacutainer® Safety
Coagulation Tube
(K013971) | Comments |
|------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for use | 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. | BD Vacutainer® Safety Coagulation tube is a
plastic evacuated blood collection tube that
provides a means of collecting, transporting and
processing blood in a closed tube. The buffered
sodium citrate additive provides an anticoagulated
specimen that may be used for clinical laboratory
coagulation assays. The benefits of a safety plastic
coagulation tube with Hemogard™ Safety Closure
Assembly are:
• Reduced risk of specimen tube breakage
• Reduced exposure to blood by laboratory
personnel and to minimize blood splatter during
stopper removal.
These benefits lead to increased safety of laboratory
personnel and reduced necessity of repeat specimen
collection. | There are minor changes to the
indications for use wording to
best align with the appropriate
use of the product and available
testing. The benefits/safety
statements for use of plastic
tubes over glass tubes have been
removed. These changes do not
result in a new intended use for
the subject device. |
| Product Code | GIM (Tubes, Vacuum Sample, With
Anticoagulant) | JKA (Tubes, Vials, Systems, Serum Separators,
Blood Collection) | GIM indicates the use of an
anticoagulant and so is more
appropriate to describe the BD
Citrate Tubes. |
| Regulation | 21 C.F.R. § 862.1675 | 21 C.F.R. § 862.1675 | Identical |
| Intended
Population | General Use – all populations | General Use – all populations | Identical |
| Evacuated Blood
Collection Tube | Yes | Yes | Identical |
| Clot/Anticoagulation | Anti-coagulation | Anti-coagulation | Identical |
| Characteristic | Subject Device: BD Vacutainer® Citrate
Blood Collection Tubes | Predicate Device: BD Vacutainer® Safety
Coagulation Tube
(K013971) | Comments |
| Tube Material | Plastic inner and outer tubes | Plastic inner and outer tubes | Equivalent; the product has
undergone like for like changes
in some materials since the
initial FDA clearance in 2001.
These differences do not raise
different questions of safety or
effectiveness. |
| 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 Additive
Ratio | 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 blue
stopper
1.8mL: Hemogard™ Translucent cap and
blue stopper | 2.7mL: Hemogard™ light blue cap and blue stopper
1.8mL: Hemogard™ Translucent cap and blue
stopper | Equivalent; the product has
undergone like for like changes
in some materials since the
initial FDA clearance in 2001.
These differences do not raise
different questions of safety or
effectiveness. |
| Tube Evacuation | Vacuum Chamber | Vacuum Chamber | Identical |
| Sterilization Method | Gamma Irradiation | Gamma Irradiation | Identical |
| Sterility Assurance
Level (SAL) | 10-3 | 10-3 | Identical |
| Shelf Life | 2.7 mL: 9 months
1.8 mL: 6 months | 2.7 mL: 9 months
1.8 mL: 6 months | Identical |
8
BD Vacutainer® Citrate Blood Collection Tubes 510(k)
Integrated Diagnostic Solutions-Specimen Management
Becton, Dickinson and Company
9
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:
10
| 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.
11
- 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.