(266 days)
No
The device description and performance studies focus on the physical characteristics and performance of a blood collection tube, with no mention of AI or ML.
No.
This device is an in vitro diagnostic medical device used for the collection, containment, preservation, and transport of human venous blood specimens for diagnostic testing, not for therapeutic purposes.
No
The device is a blood collection tube used to collect, contain, preserve, and transport blood specimens for in vitro diagnostic testing, not to perform the diagnostic testing itself.
No
The device is a physical blood collection tube with a closure assembly and additive, not a software program.
Yes, the device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states: "BD Vacutainer® K2 EDTA Blood Collection Tubes are evacuated, sterile, single use, in vitro diagnostic medical devices."
N/A
Intended Use / Indications for Use
BD Vacutainer® K2 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® K2 EDTA Blood Collection Tubes are used for Hemoglobin A1c (HbA1c) testing.
Product codes
JKA, GIM
Device Description
BD Vacutainer® K2EDTA Blood Collection Tubes are used for collection, containment, preservation, and transport of human venous blood specimens in a closed tube. The evacuated blood collection tube consists of a Vacutainer® Hemogard™ Closure Assembly, a plastic tube and EDTA additive. The EDTA anticoagulant is spray coated in the dipotassium (K2) form. The EDTA additive prevents specimen coagulation.
The plastic tubes are closed with the Vacutainer® Hemogard™ Closure Assembly which consists of a rubber stopper and protective plastic shield. The Hemogard™ Closure Assembly, introduced in 1995, is intended to help reduce user exposure to blood. All stopper/closures are color coded to reflect additive type; the closures included in this submission are lavender to indicate the presence of the EDTA additive.
The plastic tube is manufactured from Polyethylene terephthalate (PET). These plastic tubes were introduced in 1990. Plastic tubes enhance user safety and disposal because of the reduced risk of tube breakage and the availability of incineration as a method of disposal.
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
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® K2 EDTA Blood Collection Tubes at time-zero and over the shelf life: Draw Volume, X-Value, Second Stopper Pullout, Stopper/Shield Separation, Stopper Leakage, Tube Leakage and Resistance to Breakage during Drop Testing. Additionally, Ship Testing was conducted to assess the functional performance of the packaging materials. All bench testing was completed on final, finished devices and conducted on a minimum of three unique lots of product to assess potential sources of lot-to-lot variability. Each test was also completed on a subset of product sterilized in excess of the maximum specified irradiation dosage. Testing over shelf life was conducted over 13-20 months of accelerated aging, and over 13-20 months of real time aging. Real time aging studies were completed to confirm all accelerated aging data, and both sets of aging results met the predetermined acceptance criteria.
No animal studies were performed in support of this submission.
Clinical testing was conducted on blood collected in both the subject devices (BD Vacutainer® K2 EDTA Blood Collection Tubes), and legally marketed comparator devices 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 HbA1C with the distribution of subjects selected to be approximately representative of the general US population. Results based on pre-determined acceptance criteria demonstrated the BD Vacutainer® K2 EDTA Blood Collection Tubes are suitable for use in HbA1C testing.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
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.
0
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February 2, 2024
Becton, Dickinson and Company Brice Biggins Sr. Regulatory Affairs Specialist, SM 1 Becton Drive Franklin Lakes, New Jersey 07417
Re: K231373
Trade/Device Name: BD Vacutainer® K2 EDTA Blood Collection Tubes Regulation Number: 21 CFR 862.1675 Regulation Name: Blood Specimen Collection Device Regulatory Class: Class II Product Code: JKA, GIM Dated: January 4, 2024 Received: January 4, 2024
Dear Brice Biggins:
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" (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).
1
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 QS 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.
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).
Sincerely,
Paula V. Caposino -S
Paula Caposino, Ph.D. Acting Deputy Division Director Division of Chemistry and Toxicology Devices OHT7: Office of In Vitro Diagnostics Office of Product Evaluation and Quality Center for Devices and Radiological Health
2
Indications for Use
510(k) Number (if known) K231373
Device Name
BD Vacutainer® K2 EDTA Blood Collection Tubes
Indications for Use (Describe)
BD Vacutainer® K2 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® K2 EDTA Blood Collection Tubes are used for Hemoglobin A1c (HbA1c) testing.
| 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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3
న్. 510(K) SUMMARY K231373
5.1 Device Name
BD Vacutainer® K2 EDTA Blood Collection Tubes
Summary Preparation Date: 5.2
Date: 12/22/2023
5.3 Submitted by:
Becton, Dickinson and Company 1 Becton Drive Franklin Lakes, NJ 07417-1885
Phone: (201) 847-6800
Contact: 5.4
Brice Biggins Senior Regulatory Affairs Specialist, SM Phone: (410) 456-3633 email: Brice.Biggins@bd.com
ર્સ્ટ Alternate Contact:
Matthew Trachtenberg Director Regulatory Affairs, SM email: Matthew Trachtenberg(@BD.com Phone: (201) 847-6337
Proprietary Names: 5.6
BD Vacutainer® K2 EDTA Blood Collection Tubes
5.7 Common or Usual Names:
EDTA Blood Collection Tubes
ર્સ્ક Regulatory Information:
Classification Name: Tubes, Vacuum Sample, With Anticoagulant Classification Regulation: 21 CFR § 862.1675 Regulatory Class: Class II Product Code: GIM/JKA
4
5.9 Predicate Device(s):
K981013 Vacutainer® Brand Plus Tube with EDTA Anticoagulant
Device Establishment 5.10
Becton, Dickinson and Company
5.11 Registration Number:
2243072
Performance Standards: 5.12
- . ASTM D4169-22 Standard Practice for Performance Testing of Shipping Containers and Systems
- 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 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 14971:2019 Medical Devices Application of risk management to medical . devices
5.13 Intended Use
BD Vacutainer® K2 EDTA Blood Collection Tubes are evacuated, sterile, single use, in vitro diagnostic medical devices. They are intended to be used by trained healthcare
5
professionals for the collection, containment, preservation, and transport of human venous blood specimens used for in vitro diagnostic testing.
BD Vacutainer® K2 EDTA Blood Collection Tubes are used for Hemoglobin A1c (HbA1c) testing."
5.14 Device Description
BD Vacutainer® K2EDTA Blood Collection Tubes are used for collection, containment, preservation, and transport of human venous blood specimens in a closed tube. The evacuated blood collection tube consists of a Vacutainer® Hemogard™ Closure Assembly, a plastic tube and EDTA additive. The EDTA anticoagulant is spray coated in the dipotassium (K2) form. The EDTA additive prevents specimen coagulation.
The plastic tubes are closed with the Vacutainer® Hemogard™ Closure Assembly which consists of a rubber stopper and protective plastic shield. The Hemogard™ Closure Assembly, introduced in 1995, is intended to help reduce user exposure to blood. All stopper/closures are color coded to reflect additive type; the closures included in this submission are lavender to indicate the presence of the EDTA additive.
The plastic tube is manufactured from Polyethylene terephthalate (PET). These plastic tubes were introduced in 1990. Plastic tubes enhance user safety and disposal because of the reduced risk of tube breakage and the availability of incineration as a method of disposal.
Substantial Equivalence રું 15
The subject and predicate device are substantially equivalent as described in Table 1.
6
| Characteristic | Subject Device | Predicate Device | Comments |
|---|---|---|---|
| BD Vacutainer® K2EDTA | Vacutainer® Brand Plus Tube with | ||
| Blood Collection Tubes | EDTA Anticoagulant | ||
| K981013 | |||
| Indication for use | BD Vacutainer® K2 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® K2 EDTA | |||
| Blood Collection Tubes are | |||
| used for Hemoglobin A1c | |||
| (HbA1c) testing. | The Vacutainer® Brand PLUS (plastic) | ||
| Tube with EDTA anticoagulant 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.1 | The intended use of the subject device is the same as | ||
| the predicate with regard to the claims for | |||
| collection, and transportation of blood for in vitro | |||
| diagnostic use, with the subject device providing | |||
| additional clarity on certain information consistent | |||
| with current best practices. The addition of HbA1c | |||
| is not considered a new intended use because the | |||
| subject and predicate devices are both intended for | |||
| determination of analytes in whole blood. HbA1c is | |||
| a diagnostic test completed on a venous whole blood | |||
| sample. | |||
| Therefore, the subject and predicate devices have | |||
| the same intended use. | |||
| Intended | |||
| Population | General Use - all populations | General Use - all populations | Identical |
| Evacuated Blood | |||
| Collection Tube | Yes | Yes | Identical |
| Clot/Anti- | |||
| coagulation | Anti-coagulation | Anti-coagulation | Identical |
| Additive Type | K2EDTA | K2EDTA | Identical |
| Additive | |||
| Quantity | 1.8 mg/mL | 1.8 mg/mL | Identical |
| Tube Dimensions | |||
| (mm) | 13x75, 13x100, 16x100 | 13x75 | The additional sizes do not raise different questions |
| of safety or effectiveness. | |||
| Draw Volume | 2, 3, 4, 6, 10 mL | 6 mL | The additional draw volumes do not raise different |
| questions of safety or effectiveness. | |||
| Tube Material | Plastic | Plastic | Identical |
| Tube Closure | Hemogard™ Safety Closure | Hemogard™ Safety Closure | Identical |
| Stopper | |||
| Fabrication | Compression Molded Rubber | Compression Molded Rubber | Identical |
| Hemogard™ | |||
| Shield fabrication | Injection Molded Plastic | Injection Molded Plastic | Identical |
| Additive | |||
| Dispense | Spray Dry (K2EDTA) | Spray Dry (K2EDTA) | Identical |
| Tube Evacuation | Vacuum Chamber | Vacuum Chamber | Identical |
| Unit Labeling | Printed paper label | Printed paper label or imprinted on tube | Changing from paper label and imprinted label |
| options to paper label only does not raise different | |||
| questions of safety or effectiveness. | |||
| Sterilization | |||
| Method | Gamma Irradiation | Gamma Irradiation | Identical |
| Sterility | |||
| Assurance Level | |||
| (SAL) | $ |