BD Vacutainer® K2EDTA Blood Collection Tubes
Device Facts
| Record ID | BK230980 |
|---|---|
| Device Name | BD Vacutainer® K2EDTA Blood Collection Tubes |
| Applicant | Becton, Dickinson & Company Franklin Lakes, NJ |
| Product Code | GIM · Clinical Chemistry |
| Decision Date | Apr 17, 2024 |
| Decision | SESE |
| Regulation | 21 CFR 862.1675 |
| Device Class | Class 2 |
| Attributes | Pediatric |
Indications for Use
BD Vacutainer® K₂EDTA Blood Collection Tubes are plastic, 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 Blood Collection Tubes may be used for immunohematology testing, such as ABO blood 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.
Device Story
Evacuated plastic tube containing spray-dried K₂EDTA anticoagulant; used for collection, containment, preservation, and transport of human venous blood. Operated by trained healthcare professionals in clinical settings. Tube features Hemogard™ safety closure to reduce user blood exposure. Input is venous blood; output is a contained specimen for in vitro diagnostic testing. Device facilitates clinical decision-making by ensuring specimen integrity for immunohematology assays. Benefits include reduced risk of breakage compared to glass and enhanced safety via closed-system design.
Clinical Evidence
Clinical equivalence demonstrated via comparative testing of blood collected in subject vs. comparator devices. Evaluated immunohematology parameters (ABO grouping/Rh typing) in a cohort representative of the US population. Additional studies confirmed within-tube stability, shelf-life performance, and repeatability/reproducibility. All results met pre-determined acceptance criteria.
Technological Characteristics
Sterile, evacuated plastic (PET) tubes; 13x75, 13x100, 16x100 mm dimensions. Additive: 1.8 mg/mL spray-dried K₂EDTA. Closure: Hemogard™ safety assembly (rubber stopper/plastic shield). Sterilization: Gamma irradiation (ANSI AAMI ISO 11137). Shelf-life: 12-16 months. Standards: ASTM D4169-22, ISO 14971:2019.
Indications for Use
Indicated for all patient populations requiring venous blood collection for in vitro diagnostic testing, specifically immunohematology testing including ABO blood grouping and Rh typing.
Regulatory Classification
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.
Predicate Devices
- BD Vacutainer® Plus K₂EDTA Tubes (BK050036)
Reference Devices
Submission Summary (Full Text)
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BD Vacutainer® K₂EDTA Blood Collection Tubes
BD Life Sciences, Integrated Diagnostic Solutions, Specimen Management
Becton, Dickinson and Company
## 5 510(K) SUMMARY
### 5.1 Device Name:
BD Vacutainer® K₂EDTA Blood Collection Tubes
### 5.2 Summary Preparation Date:
November 1, 2024
### 5.3 Submitted by:
Becton, Dickinson and Company
1 Becton Drive
Franklin Lakes, NJ 07417-1885
Phone: (201) 847-6800
### 5.4 Contact:
Alexandra Kirby
Staff Regulatory Affairs Specialist
Email: Alexandra.Kirby@bd.com
Phone: (b) (6)
### 5.5 Proprietary Names:
BD Vacutainer® K₂EDTA Blood Collection Tubes
### 5.6 Common or Usual Names:
EDTA Blood Collection Tube
### 5.7 Regulatory Information:
Classification Name: Tubes, Vacuum Sample, With Anticoagulant
Classification Regulation: 21 CFR § 862.1675
Regulatory Class: Class II
Product Code: GIM
### 5.8 Predicate Device(s):
BK050036 BD Vacutainer® Plus K₂EDTA Tubes
### 5.9 Device Establishment
Becton, Dickinson and Company
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BD Vacutainer® K₂EDTA Blood Collection Tubes
BD Life Sciences, Integrated Diagnostic Solutions, Specimen Management
Becton, Dickinson and Company
**5.10 Registration Number:**
2243072
**5.11 Performance Standards:**
- 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
**5.12 Intended Use**
BD Vacutainer® K₂EDTA Blood Collection Tubes are plastic, 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 Blood Collection Tubes may be used for immunohematology testing, such as ABO blood 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.
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BD Vacutainer® K$_{2}$EDTA Blood Collection Tubes
BD Life Sciences, Integrated Diagnostic Solutions, Specimen Management
Becton, Dickinson and Company
### 5.13 Device Description
BD Vacutainer® K$_{2}$ EDTA 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 (K$_{2}$) 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.
### 5.14 Substantial Equivalence
The subject and predicate device are substantially equivalent as described in Table 2.
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BD Vacutainer® K2EDTA Blood Collection Tubes
BD Life Sciences, Integrated Diagnostic Solutions, Specimen Management
Becton, Dickinson and Company
**Table 2. Substantial Equivalence Comparison**
| Characteristic | Subject Device BD Vacutainer® K2EDTA Blood Collection Tubes | Predicate Device BD Vacutainer® Plus K2EDTA Tubes BK050036 | Comments |
| --- | --- | --- | --- |
| Indication for use | BD Vacutainer® K2EDTA Blood Collection Tubes are plastic, 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 Blood Collection Tubes may be used for immunohematology testing, such as ABO blood 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® Plus Serum Tubes, BD Vacutainer® SST™ Plus Tubes, BD Vacutainer® SST™ Glass Tubes, and BD Vacutainer® SST™ II Advance Tubes may be used for routine blood donor screening and diagnostic testing of serum for infectious disease. The performance characteristics of these tubes have not been established for infectious disease 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® Plus Serum and BD Vacutainer® Plus K2EDTA Tubes may be used for routine immunohematology testing and blood donor screening. 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. | The proposed indication for use is the same as the predicate with regards to the claim for immunohematology testing and the performance characteristics disclaimer, with the exception of more explicitly stating the intended user (trained healthcare professional) and removing blood donor screening. The subject device indication for use provides additional clarity on certain information consistent with current best practices. Therefore, the subject and predicate devices have the same intended use. |
| Intended Population | General Use – all populations | General Use – all populations | Identical. |
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# BD Vacutainer® K$_{2}$EDTA Blood Collection Tubes
BD Life Sciences, Integrated Diagnostic Solutions, Specimen Management
Becton, Dickinson and Company
| Characteristic | Subject Device BD Vacutainer® K_{2}EDTA Blood Collection Tubes | Predicate Device BD Vacutainer® Plus K_{2}EDTA Tubes BK050036 | Comments |
| --- | --- | --- | --- |
| Evacuated Blood Collection Tube | Yes | Yes | Identical. |
| Clot/Anti- coagulation | Anti-coagulation | Anti-coagulation | Identical. |
| Additive Type | K_{2}EDTA | K_{2}EDTA | Identical. |
| Additive Quantity | 1.8 mg/mL | 1.8 mg/mL | Identical. |
| Tube Dimensions (mm) | 13x75, 13x100, 16x100 | 13x75, 13x100, 16x100 | Identical. |
| Draw Volume | 2, 3, 4, 6, 10 mL | 2, 3, 4, 6, 10 mL | Identical. |
| Tube Material | Plastic | Plastic | Identical. |
| Tube Closure | Hemogard™ Safety Closure | Conventional or Hemogard™ Safety Closure | Only Hemogard™ Safety Closure versions are included in this 510(k) submission. This difference does not raise different questions of safety or effectiveness. |
| Stopper Fabrication | Compression Molded Rubber | Compression Molded Rubber | Identical |
| Hemogard™ Shield fabrication | Injection Molded Plastic | Injection Molded Plastic | Identical. |
| Additive Dispense | Spray Dry (K_{2}EDTA) | Spray Dry (K_{2}EDTA) | 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) | ≤ 10^{-3} | ≤ 10^{-3} | Identical. |
| Shelf-Life | 12-16 months | 15-24 months | Differences in shelf-life are based on the data available at the time of submission for each tube configuration and do not raise different questions of safety or effectiveness. |
| 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. |
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BD Vacutainer® K$_{2}$EDTA Blood Collection Tubes
BD Life Sciences, Integrated Diagnostic Solutions, Specimen Management
Becton, Dickinson and Company
The following discussion on substantial equivalence is pursuant to FDA Guidance dated . July 28, 2014, the 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications.
#### 5.14.1.1 *Intended Use/Indications for Use*
The predicate 510(k) for BD Vacutainer® Plus K$_{2}$EDTA Tubes (BK050036) refers to an immunohematology intended use in addition to use for blood donor screening. The proposed indication for use is the same as the predicate with regards to the claim for immunohematology testing and the performance characteristics disclaimer, with the exception of more explicitly stating the intended user (trained healthcare professional) and removing blood donor screening. The subject device indication for use provides additional clarity on certain information consistent with current best practices; e.g., the statement, “such as ABO blood grouping and Rh typing.” This additional terminology is consistent with what was cleared under BK980011 for BD Vacutainer® Plus K$_{2}$EDTA Tubes, and more recently under BK210649 for BD Vacutainer® ACD Blood Collection Tubes.
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 professional.
Therefore, using BK050036 as the predicate satisfies the requirement to have an appropriate predicate where both the subject and predicate devices have the same intended use.
#### 5.14.1.2 *Technological Characteristics*
Both the subject and predicate tubes cleared under BK050036 have similar technological characteristics. They both use K$_{2}$EDTA anticoagulant that has been spray dried onto a sterile evacuated plastic tube and closed with a Hemogard™ closure.
Differences between the subject and predicate and justification that such differences do not raise different questions of safety and effectiveness are described below:
**Tube Closure:** Only Hemogard™ Safety Closure versions are included in this 510(k) submission. Limiting the tube closure to only one version does not raise different questions of safety and effectiveness.
**Unit Labelling:** Changing from paper label and imprinted label options to a paper label only does not raise different questions of safety or effectiveness.
**Shelf-Life:** Regarding the varied shelf-life, the shelf-life is established based on available shelf-life data so difference in shelf-life do not raise different questions of safety and effectiveness. Testing was completed on the subject device and demonstrated that the product requirements were met.
### 5.15 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® K$_{2}$EDTA Blood Collection Tubes at time-zero and over the proposed shelf-life: Draw Volume,
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BD Vacutainer® K$_{2}$EDTA Blood Collection Tubes
BD Life Sciences, Integrated Diagnostic Solutions, Specimen Management
Becton, Dickinson and Company
X-Value, Second Stopper Pullout, Stopper/Shield Separation, Stopper Leakage, Tube Leakage, Resistance to Breakage during Drop Testing, and Resistance to Breakage During Centrifugation. 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, during which the devices were subjected to storage at 40°C and 50% Relative Humidity (RH) to accelerate the aging process according to the Arrhenius equation, and over 13-20 months of real time aging, during which the devices were subjected to storage at 25°C and 50% RH. Test intervals were selected as at least 16 months K$_{2}$EDTA products with a 15-month shelf-life; at least 17 months for K$_{2}$EDTA products with a 16-month shelf-life; at least 13 months for K$_{2}$EDTA products with a 12-month shelf-life. Real time aging studies were completed to confirm all accelerated aging data, and both sets of aging results met the predetermined acceptance criteria.
### **5.16 Performance Testing – Animal Summary**
No animal studies were performed in support of this submission.
### **5.17 Performance Testing – Clinical Summary**
Clinical testing was conducted on blood collected in both the subject devices (BD Vacutainer® K$_{2}$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 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 Vacutainer® K$_{2}$EDTA Blood Collection Tubes are suitable for use in immunohematology testing.
### **5.18 Conclusion**
The technical performance characteristics of the subject device are unchanged. The BD Vacutainer® K$_{2}$EDTA Blood Collection Tubes and the predicate devices have the same intended use and any differences in technological characteristic do not raise different questions of safety and effectiveness. Non-Clinical and Clinical Performance Testing support the determination that the subject BD Vacutainer® K$_{2}$EDTA Blood Collection Tubes continue to perform as intended. Based on information provided in this submission, the subject device is substantially equivalent to the predicate devices.
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