(641 days)
BD Vacutainer® K3EDTA Blood Collection Tube Pre-Amendment Device
No
The device is a blood collection tube and the description and performance studies focus on its physical properties and ability to preserve blood samples for standard laboratory testing. There is no mention of AI or ML in the intended use, device description, or performance studies.
No.
The device is an in vitro diagnostic (IVD) medical device used for collecting, preserving, and transporting blood specimens for diagnostic testing, not for treating a disease or condition.
No
Explanation: This device is for the collection, containment, preservation, and transport of human venous blood specimens for in vitro diagnostic testing, not for performing the diagnostic test itself. It is a sample collection device, not a diagnostic device.
No
The device description clearly states it is a physical blood collection tube made of glass with a closure assembly and additive, not a software program.
Yes, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states: "BD Vacutainer® EDTA Blood Collection Tubes are evacuated, sterile, single use, in vitro diagnostic medical devices."
This statement directly identifies the device as an in vitro diagnostic. The subsequent description of its use for collecting and preserving blood specimens for in vitro diagnostic testing further supports this classification.
N/A
Intended Use / Indications for Use
BD Vacutainer® EDTA 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 used for in vitro diagnostic testing.
BD Vacutainer® K2EDTA and K3EDTA Blood Collection Tubes are used for testing in hematology including white blood cells (WBC), red blood cells (RBC), red blood cell distribution width (RDW), hemoglobin (HgB), hematocrit (HCT), mean corpuscular volume (MCV), mean corpuscular hemoglobin (MCH), mean corpuscular hemoglobin concentration (MCHC), platelets, and 5-part white blood cell (WBC) differential counts (neutrophils, lymphocytes, monocytes, eosinophils, basophils).
Product codes
GIM
Device Description
BD Vacutainer® K2EDTA Blood Collection Tubes and BD Vacutainer® K3EDTA Blood Collection Tubes are for collecting, transporting and centrifuging blood in a closed tube. The blood collection tube consists of closure assembly, a plass tube and EDTA additive.
The standard closure assembly is a basic rubber stopper. The tube is also available with the Vacutainer® Hemogard™ Closure Assembly which consists of a rubber stopper and protective plastic shield to reduce user exposure to blood. All stopper/closures are color coded to reflect additive type; the closures included in this submission are either pink or lavender to indicate the presence of the EDTA additive.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
human venous blood specimens
Indicated Patient Age Range
General Use – all populations
Intended User / Care Setting
trained healthcare professionals
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® EDTA 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
- Ship Testing for Functional Performance of Packaging Materials: Pass
The BD Vacutainer® EDTA 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. These performance tests demonstrate that the modifications to the device do not impact its safety or effectiveness and that the subject BD Vacutainer® EDTA Blood Collection Tubes continue to perform as intended.
Clinical Performance Testing: The suitability of the BD Vacutainer® EDTA Blood Collection Tubes for collection of clinical samples was demonstrated through testing performed internally and externally which demonstrated clinical equivalency to the venous comparator tube by performing the following studies: Method Comparison (Clinical Equivalence), Precision, Within-Tube Type Stability, and Shelf Life. Testing was performed on identified analytes (i.e., White Blood Cell Count (WBC), Red Blood Cell Count (RBC), Hemoglobin, Hematocrit, Platelet Count, Neutrophil %, Lymphocyte %, Monocyte %, Eosinophil %, Basophil %, Mean Corpuscular Hemoglobin, Mean Corpuscular Hemoglobin Concentration, Mean Corpuscular Volume, and Red Cell Distribution Width."
Method Comparison: This study was performed to evaluate Clinical Equivalence between the evaluate the performance of BD Vacutainer® EDTA Blood Collection Tubes against legally marketed comparator tubes., for the analytes identified above. This assessment considered whether the mean and the two one-sided 95% Confidence Limits of the paired sample biases were within the Clinical Acceptance Limits (CALs). Clinical equivalency was demonstrated for all hematology parameters for each tube comparison except Hgb, PLT, and WBC at the low medically relevant points on two instruments. For these three analytes the mean bias was within the predefined clinical acceptance limits, but exceeded the confidence interval. The observed non-equivalence is clinically acceptable, as the number of data points at the low medically relevant points were insufficient to adequately power the analysis.
Lot to Lot Variability: This study was performed to evaluate non-inferiority of the BD Vacutainer® K2EDTA tube for repeatability (within tube) and reproducibility (lot-to-lot and tube-to-tube) variation using hematology parameters identified above. Performance of the BD Vacutainer® K2EDTA Tubes with Hemogard™ closure for repeatability. lot-to-lot variation and tube-to-tube variation showed non-inferiority for all tube comparisons for the hematology parameters tested on two instrument platforms when compared with a comparator device.
Within-Tube Type Stability: This study evaluated within-tube type stability of BD Vacutainer® EDTA Blood Collection Tubes by comparing samples taken from the same subject in the candidate tubes at various identified time points and storage conditions. All analytes demonstrated stability at 12- and 24-hours storage Room Temperature, 24 hours Refrigerated, 24 hours Room Temperature followed by 24 hours Refrigerated.
Shelf-Life: The purpose of this study was to evaluate product shelf-life by evaluating evaluate Shelf-Life performance (11+1 months or 10+1 months from date of manufacture) of BD Vacutainer® K2EDTA and K3EDTA Blood Collection Tubes with Hemogard™ closure and Conventional closure, respectively, in comparison with recently manufactured BD Vacutainer® K2EDTA and K3EDTA Blood Collection Tubes for selected hematology test parameters. Real time clinical stability testing performed using clinical samples demonstrated a shelf life of 11 months for BD Vacutainer® K2EDTA Blood Collection Tubes and 10 months for BD Vacutainer® K3EDTA Blood Collection Tubes.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
BD Vacutainer® K3EDTA Blood Collection Tube Pre-Amendment Device
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
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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.
August 25, 2023
Becton Dickinson and Company Katherine Lemus Senior Regulatory Affairs Specialist 1 Becton Drive Franklin Lakes, New Jersey 07417
Re: K213670
Trade/Device Name: BD Vacutainer K2EDTA Blood Collection Tubes, BD Vacutainer K3EDTA Blood Collection Tubes Regulation Number: 21 CFR 862.1675 Regulation Name: Blood specimen collection device Regulatory Class: Class II Product Code: GIM Dated: November 19, 2021 Received: November 22, 2021
Dear Katherine Lemus:
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
1
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 803) 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 medical devices and radiation-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,
Min Wu-S
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) K213670
Device Name
BD Vacutainer® K2EDTA Blood Collection Tubes and BD Vacutainer® K3EDTA Blood Collection Tubes
Indications for Use (Describe)
BD Vacutainer® EDTA 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, contamment, preservation, and transport of human venous blood specimens used for in vitro diagnostic testing.
BD Vacutainer® K2EDTA and K3EDTA Blood Collection Tubes are used for testing in hematology including white blood cells (WBC), red blood cells (RBC), red blood cell distribution width (RDW), hemoglobin (HgB), hematocrit (HCT), mean corpuscular volume (MCV), mean corpuscular (MCH), mean corpuscular hemoglobin concentration (MCHC), platelets, and 5-part white blood cell (WBC) differential counts (neutrophils, lymphocytes, monocytes, eosinophils, basophils).
| Type of Use (Select one or both, as applicable) |
|---|
| X 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® K2EDTA Blood Collection Tubes and BD Vacutainer® K3EDTA Blood Collection Tubes
Summary Preparation Date: 1.2
Date: 5/21/2023
1.3 Submitted by:
Becton, Dickinson and Company 1 Becton Drive Franklin Lakes, NJ 07417-1885
Phone: (201) 847-6800
1.4 Contact:
Katherine Kenner Lemus, MS, RAC-US Senior Regulatory Affairs Specialist email: Katherine.Lemus@bd.com
Phone: (801) 541-9274 Work: (201) 847 6800
1.5 Alternate Contact:
Matthew Trachtenberg Director Regulatory Affairs email: Matthew.trachtenberg@bd.com
Phone: (201) 847-6337 Work: (201) 847-6800
1.6 Proprietary Names:
BD Vacutainer® K2EDTA Blood Collection Tubes and BD Vacutainer® K3EDTA Blood Collection Tubes
1.7 Common or Usual Names:
EDTA Blood Collection Tube
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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(s):
K981013 Vacutainer® Brand Plus Tube with EDTA Anticoagulant
1.10 Device Establishment
Becton, Dickinson and Company
1.11 Registration Number:
2243072
Performance Standards: 1.12
ASTM D4169-16 Standard Practice for Performance Testing of Shipping Containers and Svstems
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 microorganisms 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
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1.13 Intended Use
BD Vacutainer® EDTA 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 used for in vitro diagnostic testing.
BD Vacutainer® K2EDTA and K3EDTA Blood Collection Tubes are used for testing in hematology including white blood cells (WBC), red blood cells (RBC), red blood cell distribution width (RDW). hemoglobin (HzB). hematocrit (HCT), mean corpuscular volume (MCV), mean corpuscular hemoglobin (MCH), mean corpuscular hemoglobin concentration (MCHC), platelets, and 5-part white blood cell (WBC) differential counts (neutrophils, lymphocytes, monocytes, eosinophils, basophils).
Device Description 1.14
BD Vacutainer® K2EDTA Blood Collection Tubes and BD Vacutainer® K3EDTA Blood Collection Tubes are for collecting, transporting and centrifuging blood in a closed tube. The blood collection tube consists of closure assembly, a plass tube and EDTA additive.
The standard closure assembly is a basic rubber stopper. The tube is also available with the Vacutainer® Hemogard™ Closure Assembly which consists of a rubber stopper and protective plastic shield to reduce user exposure to blood. All stopper/closures are color coded to reflect additive type; the closures included in this submission are either pink or lavender to indicate the presence of the EDTA additive.
1.15 Substantial Equivalence
The subject and predicate device are substantially equivalent as described in Table 2.
For the BD Vacutainer® K2EDTA Blood Collection Tubes, a reference device is included in this submission to support the inclusion of the K3EDTA additive.
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Table 1: Substantial Equivalence Comparison
| Characteristic | Subject Device
BD Vacutainer® K2EDTA Blood Collection
Tubes and BD Vacutainer® K3EDTA Blood
Collection Tubes | Predicate Device
Vacutainer® Brand Plus
Tube with EDTA
Anticoagulant
K981013 | Reference Device
BD Vacutainer® K3EDTA
Blood Collection Tube
Pre-Amendment Device | Comments |
|------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indication for use | BD Vacutainer® EDTA 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 used for in vitro diagnostic testing.
BD Vacutainer® K2EDTA and K3EDTA Blood
Collection Tubes are used for testing in
hematology including white blood cells (WBC),
red blood cells (RBC), red blood cell
distribution width (RDW), hemoglobin (HgB),
hematocrit (HCT), mean corpuscular volume
(MCV), mean corpuscular hemoglobin (MCH),
mean corpuscular hemoglobin concentration
(MCHC), platelets, and 5-part white blood cell
(WBC) differential counts (neutrophils,
lymphocytes, monocytes, eosinophils,
basophils). | The Vacutainer® Brand PLUS
(plastic) Tube with EDTA
anticoagulant and Vacutainer®
Brand Serum Tube are
evacuated blood collection
tubes which provide a means
of collecting, transporting
separating and processing
blood in a plastic tube. When
the tube is used together with
Vacutainer® Brand Needles
and Holders, is a closed
system for the collection of
venous blood with the same
indications as described
herein.
Blood collected in PLUS
EDTA and PLUS Serum tubes
can be used for
immunohematology testing
including ABO grouping, Rh
grouping, and antibody
screening which requires red
cells and plasma or serum | BD Vacutainer® K3EDTA
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 for
chemistry and hematology
determinations in plasma or
whole blood. | The proposed indication for
use is mostly equivalent to the
indication cleared under
K981013 with the exception
of more explicitly stating use
for testing in hematology.
The K981013 510(k)
Summary similarly states that
the predicate EDTA tubes "is
used primarily for clinical
laboratory hematology
studies." The subject and
predicate devices have the
same intended use |
| Intended Use | Blood Collection for hematology | Blood Collection for
hematology and
Immunohematology | Blood Collection for
chemistry and hematology | The subject intended use is the
same as the predicate intended
use for hematology |
| Intended
Population | General Use – all populations | General Use – all populations | General Use – all populations | No change |
| Characteristic | Subject Device
BD Vacutainer® K2EDTA Blood Collection
Tubes and BD Vacutainer® K3EDTA Blood
Collection Tubes | Predicate Device
Vacutainer® Brand Plus
Tube with EDTA
Anticoagulant
K981013 | Reference Device
BD Vacutainer® K3EDTA
Blood Collection Tube
Pre-Amendment Device | Comments |
| Evacuated Blood
Collection Tube | Yes | Yes | Yes | No change |
| Clot/Anti-
coagulation | Anti-coagulation | Anti-coagulation | Anti-coagulation | No change |
| Additive Type | K2EDTA, K3EDTA | K2EDTA | K3EDTA | The subject device includes
tubes with both K2EDTA and
K3EDTA additives. The
K2EDTA is the same additive
as the predicate device cleared
under K981013. The K3EDTA
additive is legally marketed
per the referenced pre-
amendment device. The
additional additive does not
raise new questions of safety
or effectiveness. |
| Additive Quantity | 1.8 mg/mL (K2EDTA), 1.75 mg/mL (K3EDTA) | 1.8 mg/mL | 1.2-4 mg/mL | There is no change in the
blood-to-additive ratio for the
K2EDTA tube. The blood-to-
additive ratio for the K3EDTA
tube is within the range cited
for pre-amendment devices.
This change does not result in
new questions of safety or
effectiveness. |
| Tube Dimensions
(mm) | 13x75,13x100,16x100 | 13x75 | 13×100 | The difference in size does not
raise new questions of safety
or effectiveness. |
| Characteristic | Subject Device
BD Vacutainer® K2EDTA Blood Collection
Tubes and BD Vacutainer® K3EDTA Blood
Collection Tubes | Predicate Device
Vacutainer® Brand Plus
Tube with EDTA
Anticoagulant
K981013 | Reference Device
BD Vacutainer® K3EDTA
Blood Collection Tube
Pre-Amendment Device | Comments |
| Draw Volume | 2, 3, 4, 6, 7, 10 mL | 6 mL | 2, 3, 3.5, 4, 5, 7, 10, 20 mL | The difference in draw
volume does not raise new
questions of safety or
effectiveness. |
| Tube Material | Plastic (K2EDTA), Glass (K3EDTA) | Plastic | Glass | No change |
| Tube Closure | Conventional or Hemogard™ Safety Closure | Conventional or Hemogard™
Safety Closure | Conventional | No change |
| Stopper Fabrication | Compression Molded Rubber | Compression molded rubber | Compression molded Rubber | No change |
| Hemogard™ Shield
fabrication | Injection Molded Plastic | Injection Molded Plastic | N/A | No change |
| Additive Dispense | Spray Dry (K2EDTA), Liquid Fill (K3EDTA) | Spray Dry (K2EDTA) | Liquid Fill (K3EDTA) | No change |
| Tube Evacuation | Vacuum Chamber | Vacuum Chamber | Vacuum Chamber | No change |
| Unit Labeling | Printed paper label | Printed paper label or
imprinted on tube | Printed paper label | Changing from paper label
and imprinted label options to
paper label only does not raise
new questions of safety or
effectiveness. |
| Sterilization
Method | Gamma Irradiation | Gamma Irradiation | Gamma Irradiation | No change |
| Sterility Assurance
Level (SAL) | ≤ 10-3 | ≤ 10-3 | ≤ 10-3 | No change |
| Shelf Life | 11 Months (K2EDTA), 10 Months (K3EDTA) | 15-24 months | 12 months | Shelf-life dates are based on
test data currently available
for subject devices.
Differences in shelf-life do not
raise new questions of safety
or effectiveness. |
| Characteristic | Subject Device
BD Vacutainer® K2EDTA Blood Collection
Tubes and BD Vacutainer® K3EDTA Blood
Collection Tubes | Predicate Device
Vacutainer® Brand Plus
Tube with EDTA
Anticoagulant
K981013 | Reference Device
BD Vacutainer® K3EDTA
Blood Collection Tube
Pre-Amendment Device | Comments |
| 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 | Unit – tube and closure
Shelf – shrink wrapped
polystyrene tray
Case - corrugated cardboard | No change |
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1.16 Performance Testing - Bench Summarv
Non-clinical performance testing was conducted following defined protocols and with established acceptance criteria to evaluate the following attributes of the BD Vacutainer® EDTA Blood Collection Tubes at time-zero and over the proposed shelf life:
| Test | Result |
|---|---|
| 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 |
| Ship Testing for Functional Performance of Packaging Materials | Pass |
The BD Vacutainer® EDTA 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. These performance tests demonstrate that the modifications to the device do not impact its safety or effectiveness and that the subject BD Vacutainer® EDTA Blood Collection Tubes continue to perform as intended.
1.17 Performance Testing - Animal Summary
No animal studies were performed in support of this submission.
1.18 Performance Testing - Clinical Summarv
The suitability of the BD Vacutainer® EDTA Blood Collection Tubes for collection of clinical samples was demonstrated through testing performed internally and externally which demonstrated clinical equivalency to the venous comparator tube by performing the following studies: Method Comparison (Clinical Equivalence), Precision, Within-Tube Type Stability, and Shelf Life. Testing was performed on identified analytes (i.e., White Blood Cell Count (WBC), Red Blood Cell Count (RBC), Hemoglobin, Hematocrit, Platelet Count, Neutrophil %, Lymphocyte %, Monocyte %, Eosinophil %, Basophil %, Mean Corpuscular Hemoglobin, Mean Corpuscular Hemoglobin Concentration, Mean Corpuscular Volume, and Red Cell Distribution Width."
Method Comparison
This study was performed to evaluate Clinical Equivalence between the evaluate the performance of BD Vacutainer® EDTA Blood Collection Tubes against legally marketed comparator tubes., for the analytes identified above. This assessment considered whether the
11
mean and the two one-sided 95% Confidence Limits of the paired sample biases were within the Clinical Acceptance Limits (CALs).
Clinical equivalency was demonstrated for all hematology parameters for each tube comparison except Hgb, PLT, and WBC at the low medically relevant points on two instruments. For these three analytes the mean bias was within the predefined clinical acceptance limits, but exceeded the confidence interval. The observed non-equivalence is clinically acceptable, as the number of data points at the low medically relevant points were insufficient to adequately power the analysis.
Lot to Lot Variability
This study was performed to evaluate non-inferiority of the BD Vacutainer® K2EDTA tube for repeatability (within tube) and reproducibility (lot-to-lot and tube-to-tube) variation using hematology parameters identified above.
Performance of the BD Vacutainer® K2EDTA Tubes with Hemogard™ closure for repeatability. lot-to-lot variation and tube-to-tube variation showed non-inferiority for all tube comparisons for the hematology parameters tested on two instrument platforms when compared with a comparator device.
Within-Tube Type Stability
This study evaluated within-tube type stability of BD Vacutainer® EDTA Blood Collection Tubes by comparing samples taken from the same subject in the candidate tubes at various identified time points and storage conditions.
All analytes demonstrated stability at 12- and 24-hours storage Room Temperature, 24 hours Refrigerated, 24 hours Room Temperature followed by 24 hours Refrigerated.
Shelf-Life
The purpose of this study was to evaluate product shelf-life by evaluating evaluate Shelf-Life performance (11+1 months or 10+1 months from date of manufacture) of BD Vacutainer® K2EDTA and K3EDTA Blood Collection Tubes with Hemogard™ closure and Conventional closure, respectively, in comparison with recently manufactured BD Vacutainer® K2EDTA and K3EDTA Blood Collection Tubes for selected hematology test parameters.
Real time clinical stability testing performed using clinical samples demonstrated a shelf life of 11 months for BD Vacutainer® K2EDTA Blood Collection Tubes and 10 months for BD Vacutainer® K3EDTA Blood Collection Tubes.
1.19 Conclusion
The technical performance characteristics of the subject device are unchanged. The proposed BD Vacutainer® EDTA 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 support the determination that the changes made to the
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BD Vacutainer® EDTA 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.