BD Vacutainer
®
ACD Blood Collection Tubes
BD Integrated Diagnostic Solutions
Becton, Dickinson and Company
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CONFIDENTIAL AND PROPRIETARY
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5 510(K) SUMMARY
5.1 Device Name
BD Vacutainer® ACD A and B Blood Collection Tubes
5.2 Summary Preparation Date:
10/22/2021
5.3 Submitted by:
Becton, Dickinson and Company
1 Becton Drive
Franklin Lakes, NJ 07417-1885
Phone: (201) 847-6800
5.4 Contact:
Chelsea Woods, RAC
Staff Regulatory Affairs Specialist
email: [email protected]
Phone: (812) 361-9061
Work: (201) 847-6800
5.5 Alternate Contact:
Matthew Trachtenberg
Director Regulatory Affairs
email: matthew.trachten[email protected]
Phone: (201) 847-6337
Work: (201) 847-6800
5.6 Proprietary Names:
BD Vacutainer
®
ACD A and B Blood Collection Tubes
5.7 Common or Usual Names:
Tubes, Vials, Systems, Serum Separators, Blood Collection
5.8 Regulatory Information
Classification Name: Tubes, Vials, Systems, Serum Separators, Blood Collection
Classification Regulation: 21 CFR §862.1675
BD Vacutainer
®
ACD Blood Collection Tubes
BD Integrated Diagnostic Solutions
Becton, Dickinson and Company
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CONFIDENTIAL AND PROPRIETARY
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Regulatory Class: Class II
Product Code: JKA
5.9 Predicate Device(s)
BD Vacutainer
®
ACD Blood Collection Tubes (Pre-Amendment)
5.10 Device Establishment
Becton, Dickinson and Company
5.11 Registration Number:
2243072
5.12 Performance Standards:
ASTM D4169-16 Standard Practice for Performance Testing of Shipping Containers and
Systems
ANSI/AAMI/ISO 11137-1:2006, A1: 2013, A2 2018 Sterilization of health care products -
Radiation - Part 1: Requirements for development, validation and routine control of a
sterilization process for medical devices
ANSI/AAMI/ISO 11137-2: 2013 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"
EN ISO 14971:2012 Medical Devices – Application of risk management to medical devices
5.13 Intended Use
BD Vacutainer
®
ACD A and B Blood Collection Tubes are evacuated, sterile, single use, in
vitro diagnostic medical devices. They are intended to be used by trained healthcare
professionals for the collection, containment, preservation, and transport of human venous blood
specimens for the purpose of in vitro diagnostic testing.
BD Vacutainer
®
ACD Blood Collection Tubes
BD Integrated Diagnostic Solutions
Becton, Dickinson and Company
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CONFIDENTIAL AND PROPRIETARY
Page 14 of 92
BD Vacutainer
®
ACD A and B Blood Collection Tubes may be used for testing in
immunohematology, such as ABO grouping and Rh typing.
The performance characteristics of these tubes have not been established for immunohematology
testing in general; therefore, users must validate the use of these tubes for their specific assay-
instrument/reagent system combinations and specimen storage conditions.
5.14 Device Description
The BD ACD Tubes are evacuated glass blood collection tubes that are provided sterile.
The Acid Citric Dextrose (ACD) solution is comprised of Trisodium Citrate, Citric Acid and
Dextrose, and are available with either ACD Solution A or ACD Solution B. ACD Solution A
(ACD-A) consists of Trisodium Citrate, 22.0 g/L, Citric Acid, 8.0 g/L, and Dextrose, 24.5 g/L.
ACD Solution B (ACD-B) consists of Trisodium Citrate, 13.2 g/L, Citric Acid, 4.8 g/L, and
Dextrose, 14.7 g/L. Both ACD Solution A and B provide an anticoagulated specimen when used
in accordance with the instructions for use.
The BD ACD tubes are closed with a conventional rubber stopper. All stopper/closures are color
coded to reflect additive type (Yellow for BD ACD Tubes). The available draw volumes are
8.5mL for Solution A (16x100mm size) and 6mL for Solution B (13x100mm size).
5.15 Substantial Equivalence
The subject and predicate device are substantially equivalent as described in Table 1.
BD Vacutainer
®
ACD Blood Collection Tubes
BD Integrated Diagnostic Solutions
Becton, Dickinson and Company
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Page 15 of 92
Table 1: Substantial Equivalence Comparison
Characteristic
BD Vacutainer® ACD Blood
Collection Tubes
BD Vacutainer® ACD Blood
Collection Tubes
Pre-Amendment
Comparison
Indications for Use
BD Vacutainer
®
ACD Blood Collection
Tubes are evacuated, sterile, single, use,
in vitro diagnostic medical devices. They
are intended to be used by trained
healthcare professionals for the
collection, containment, preservation, and
transport of human venous blood
specimens for the purpose of in vitro
diagnostic testing.
BD Vacutainer
®
ACD Blood Collection
Tubes are used for testing in
immunohematology, such as ABO
grouping and Rh typing.
The performance characteristics of these
tubes have not been established for
immunohematology testing in general;
therefore, users must validate the use of
these tubes for their specific assay-
instrument/reagent system combinations
and specimen storage conditions.
BD Vacutainer
®
ACD Blood Collection
Tubes are intended for the collection of a
plasma specimen in a closed evacuated
system. The tube may be used for in vitro
diagnostic testing where red cell
preservation is required.
The preamendment BD ACD Tubes refer
to “red cell preservation.” The subject
510(k) submission for BD ACD Tubes
includes more specific information,
including use for testing in
immunohematology. Immunohematology
is the study of red blood cell antigens and
antibodies. The proposed indications for
use represents a subset of the prior
indications for use and includes
additional more detailed information
consistent with current best practices; the
changes do not result in a new intended
use.
Intended Population
General Use – all populations
General Use – all populations
Evacuated Blood Collection
Tube
Yes Yes Identical
Draw Volume
ACD-B: 6 mL
ACD-A: 8.5 mL
ACD-B: 6 mL
ACD-A: 8.5 mL
Identical
Sample Type
Plasma
Plasma
Additive Type
Acid Citric Dextrose Acid Citric Dextrose Identical
BD Vacutainer
®
ACD Blood Collection Tubes
BD Integrated Diagnostic Solutions
Becton, Dickinson and Company
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CONFIDENTIAL AND PROPRIETARY
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Characteristic
BD Vacutainer® ACD Blood
Collection Tubes
BD Vacutainer® ACD Blood
Collection Tubes
Pre-Amendment
Comparison
Additive Quantity
Solution A:
22.0 g/L Trisodium Citrate
8.0 g/L Citric Acid
24.5 g/L Dextrose
Solution B:
13.2 g/L Trisodium Citrate
4.8 g/L Citric Acid
14.7 g/L Dextrose
Solution A
Solution B
Identical
Tube Dimensions
ACD-B: 13x100mm
ACD-A: 16x100mm
ACD-B: 13x100mm
ACD-A: 16x100mm
Identical
Tube Material
Glass
Glass
Tube Closure
Conventional yellow stopper
Conventional yellow stopper
Additive Dispense Liquid Fill Liquid Fill Identical
Sterilization Method
Irradiation
Irradiation
Sterility Assurance Level
(SAL)
10
-3
10
-3
Identical
Shelf Life
14 months
24 months
currently available and additional testing
is ongoing to support future shelf-life
extensions. This difference does not
raise new questions of safety or
Unit Labeling
Paper Label
Paper Label
Packaging
Unit – tube and closure
Shelf – shrink wrapped polystyrene tray
Case – corrugated cardboard
Unit – tube and closure
Shelf – shrink wrapped polystyrene tray
Case – corrugated cardboard
Identical
BD Vacutainer
®
ACD Blood Collection Tubes
BD Integrated Diagnostic Solutions
Becton, Dickinson and Company
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CONFIDENTIAL AND PROPRIETARY
Page 17 of 92
5.15.1 Discussion on Substantial Equivalence
Intended Use
The preamendment BD ACD Tubes refer to “red cell preservation.” The subject 510(k)
submission for BD ACD Tubes includes more specific information, including use for testing in
immunohematology. Immunohematology is the study of red blood cell antigens and antibodies.
The proposed indications for use represent a subset of the prior indications for use and includes
additional more detailed information consistent with current best practices; the changes do not
result in a new intended use.
The intended use of the subject BD ACD tubes is a subset of the prior indications for use of the
pre-amendment BD ACD tubes that were displayed, advertised, or otherwise offered for sale
before May 28, 1976, as a device intended for the collection, processing, and transportation of a
plasma specimen in a closed evacuated system. Like the predicate device, the tube is used in
settings where a venous blood sample is collected by a trained healthcare worker.
Therefore, both the subject and predicate device have the same intended use and substantially
similar indications for use, meeting the first criteria for a finding of substantial equivalence.
Technological Characteristics
Both the subject and pre-amendment BD ACD tubes have similar technological characteristics.
Like the pre-amendment BD ACD tubes, the subject device consists of Acid Citric Dextrose
(ACD), provided as either Solution A or Solution B. The tubes continue to be made of glass,
come in two different sizes and draw volumes. Further, the closure type and color of the tubes
are substantially the same (conventional yellow stoppers).
Changes to the tube shelf-life and some materials/processing methods have been implemented
since May 28, 1976. However, these differences do not raise new questions of safety or
effectiveness. Furthermore, performance testing demonstrates that the modifications do not
impact the safety or effectiveness of the device and that the subject BD ACD Tubes continue to
perform as intended.
Principles of Operation
Both the subject and pre-amendment tubes are used for plasma preparation and are made of glass
for the collection of venous blood which upon centrifugation separates plasma for use in
immunohematology. The anticoagulant-additive mixture in ACD tubes contains trisodium
citrate, citric acid, and dextrose. The dextrose in this solution is a nutrient to enable the cells to
metabolize and be viable. The principles of operation are unchanged compared to the predicate
device.
BD Vacutainer
®
ACD Blood Collection Tubes
BD Integrated Diagnostic Solutions
Becton, Dickinson and Company
TOC
CONFIDENTIAL AND PROPRIETARY
Page 18 of 92
5.16 Performance Testing – Non-Clinical Summary
Non-clinical performance testing was conducted following defined protocols and with
established acceptance criteria to evaluate the following attributes of the BD ACD tubes at time-
zero and over the proposed shelf life: Draw Volume, X-Value, Second Stopper Pullout, Stopper
Leakage, Tube Leakage, and Resistance to Breakage During Centrifugation. Additionally, Ship
Testing was conducted to assess the functional performance of the packaging materials. The BD
ACD tubes met all non-clinical testing requirements at time-zero and over the product shelf life.
The BD ACD Tubes met all non-clinical testing requirements at time-zero and over the product
shelf life, demonstrating that the device functions as designed. These performance tests
demonstrate that the modifications to the device do not impact its safety or effectiveness and that
the subject BD ACD Tubes continue to perform as intended.
5.17 Performance Testing – Animal Summary
No animal studies were performed in support of this submission.
5.18 Performance Testing – Clinical Summary
Clinical testing was conducted on blood collected in both the subject device (BD Vacutainer
®
Glass Whole Blood ACD Blood Collection Tubes), and a legally marketed comparator device to
demonstrate Clinical Equivalence. Additional clinical testing was completed to evaluate Within-
Tube Stability, Shelf-Life Performance, and Repeatability/Reproducibility. Clinical testing was
conducted for a representative panel of immunohematology test parameters, with the distribution
of ABO grouping/Rh typing subjects selected to be approximately representative of the general
US population.
Results based on pre-determined acceptance criteria demonstrated the BD ACD tubes are
suitable for use in immunohematology testing.
5.19 Conclusion
The technical performance characteristics of the subject device are unchanged. The proposed BD
Vacutainer® ACD Blood Collection Tubes and predicate device of the same name have the same
intended use, principle of operation, and technological characteristics. Non-Clinical and Clinical
Performance Testing sufficiently support the determination that the changes made to the BD
Vacutainer® ACD Blood Collection Tubes do not raise any new concerns of safety or
effectiveness. Based on information provided in this submission the proposed device is
substantially equivalent to the predicate device.