BD Vacutainer K2EDTA Blood Collection Tubes, BD Vacutainer K3EDTA Blood Collection Tubes
by Becton, Dickinson and Company
510(k) K213670
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK213670 | Date25 Aug 2023 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- GIM
- Device Class
- Class II
- Regulation
- 21 CFR Part 862.1675
- Advisory Committee
- Clinical Chemistry
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 18 Sep 2026
The BD Vacutainer K2EDTA and K3EDTA Blood Collection Tubes are vacuum sample tubes with anticoagulant, designed for blood collection and laboratory analysis. These tubes incorporate potassium ethylenediaminetetraacetic acid (K2EDTA or K3EDTA) to prevent coagulation, ensuring stable sample integrity for hematological and clinical chemistry testing, including hematology, coagulation, and therapeutic drug monitoring.
These tubes are intended for single-use in clinical settings and are supplied sterile. They are classified as Class II medical devices under FDA regulations (862.1675) and have received FDA 510(k) clearance as substantially equivalent to predicate devices. The tubes are dimensionally stable and resistant to breakage, with centrifugation recommended at ≤1300 RCF for optimal separation. Storage and handling follow standard aseptic practices for blood collection tubes.
From the manufacturer
Choose BD Vacutainer® Blood Collection Tubes for analytical accuracy and sample quality BD offers a broad portfolio of blood collection tubes spanning the continuum of laboratory needs.
This special formulation is extremely strong, dimensionally stable, and resistant to chemicals and breakage. What speed and time should the BD Vacutainer Blood Collection tubes be spun at?
Other devices from Becton, Dickinson and Company
Questions
AI-generated answers, 18 Sep 2026
Are these tubes suitable for therapeutic drug monitoring, and if so, what types of tests can they support?
Yes, these BD Vacutainer K2EDTA and K3EDTA Blood Collection Tubes are designed for therapeutic drug monitoring as part of their intended use for clinical chemistry testing. The potassium-based EDTA anticoagulants (K2EDTA and K3EDTA) help preserve sample integrity, making them suitable for accurate measurements in hematology, coagulation studies, and clinical chemistry assays, including those for drug levels in blood.
How should I store these tubes before use, and what precautions should I take?
These tubes should be stored following standard aseptic practices for blood collection tubes. Since they are sterile and intended for single-use, they must remain unopened until use. Store them in a clean, dry environment away from direct sunlight or extreme temperatures to maintain their integrity and sterility. Avoid exposure to moisture or contaminants that could compromise the vacuum or anticoagulant properties.
Can these tubes be reused, or are they strictly for single-use only?
These BD Vacutainer K2EDTA and K3EDTA Blood Collection Tubes are explicitly designed for single-use only. Reusing them could compromise sterility, introduce contamination, or alter the anticoagulant properties, leading to inaccurate test results. Always use a fresh tube for each blood collection to ensure reliable laboratory analysis.
What is the recommended centrifugation speed for these tubes to ensure proper sample separation?
The manufacturer recommends centrifuging these tubes at a maximum speed of ≤1300 Relative Centrifugal Force (RCF) for optimal separation of blood components. Exceeding this speed may cause hemolysis or sample degradation, affecting the accuracy of hematological or clinical chemistry tests.
What regulatory pathway was followed for FDA clearance, and what does this mean for clinical use?
These tubes received FDA 510(k) clearance under the Traditional 510(k) Review pathway, with a decision code of SESE (Substantially Equivalent). This means the FDA determined they are substantially equivalent to a legally marketed predicate device in terms of technology, performance, and intended use. Clinically, this clearance confirms the tubes meet FDA safety and effectiveness standards for blood collection and laboratory analysis as described in the device labeling.