BD Vacutainer K2 EDTA Blood Collection Tubes
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K231373 FDA 510(k)
- FDA Product Code
- JKA FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 862.1675 FDA 510(k)
- Regulation Number
- 862.1675 FDA 510(k)
- Advisory Committee
- Clinical Chemistry FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The BD Vacutainer K2 EDTA Blood Collection Tubes are Blood Collection Tubes designed for venipuncture and capillary blood sampling. These tubes contain potassium ethylenediaminetetraacetic acid (K2 EDTA) as an anticoagulant to preserve whole blood samples for hematological analysis, including complete blood counts (CBC) and coagulation studies.
These tubes are supplied as single-use, sterile, plastic devices in sizes such as 6 mL with a 13 x 100 mm dimension. They are intended for use in clinical laboratories and healthcare settings, adhering to FDA 510(k) clearance under the Clinical Chemistry advisory committee. The tubes are non-MRI-safe and must be stored according to manufacturer guidelines to maintain sterility and performance.
Frequently asked questions
What types of blood tests are these tubes specifically designed for, and why is K2 EDTA used as the anticoagulant?
These BD Vacutainer® K2 EDTA Blood Collection Tubes are specifically designed for hematological analysis, including complete blood counts (CBC) and coagulation studies. K2 EDTA is used as the anticoagulant because it binds calcium ions, preventing blood clotting while preserving cell morphology and integrity. This ensures accurate and reliable results for these types of tests.
Are these tubes suitable for both venipuncture and capillary blood sampling, and how are they supplied?
Yes, these BD Vacutainer® K2 EDTA Blood Collection Tubes are designed for use in both venipuncture and capillary blood sampling. They are supplied as single-use, sterile, plastic devices in a 6 mL size with dimensions of 13 x 100 mm, ensuring they meet clinical and laboratory requirements for blood collection.
Can these tubes be reused, and what storage instructions should be followed to maintain their performance?
No, these BD Vacutainer® K2 EDTA Blood Collection Tubes are intended for single-use only. To maintain sterility and performance, they must be stored according to the manufacturer’s guidelines, which likely include keeping them in a clean, dry environment away from direct sunlight or extreme temperatures.
Are these tubes safe to use in an MRI environment, and if not, why?
No, these BD Vacutainer® K2 EDTA Blood Collection Tubes are explicitly labeled as non-MRI-safe. This means they should not be used in or near an MRI machine, as the materials may react to the magnetic field, posing a risk to both the patient and the equipment.
What is the regulatory pathway for these tubes, and how does that affect their use in clinical settings?
These tubes follow the FDA 510(k) clearance pathway, specifically under the Clinical Chemistry advisory committee (CH). The clearance type is Traditional, meaning they were determined to be substantially equivalent to a legally marketed predicate device. This regulatory route ensures they meet FDA standards for safety and effectiveness, allowing their use in clinical laboratories and healthcare settings as intended.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: BD Vacutainer® EDTA Tubes - 366643 | BD, BD Vacutainer® blood collection tubes | BD, BD Vacutainer Plastic Blood Collection Tubes with K2 EDTA: Hemogard ..., BD (company) - Wikipedia
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K231373 | Class II | Active |
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Manufacturer
- Manufacturer
- Becton, Dickinson and Company
Sources (1)
- FDA 510(k) K231373 24 fields · synced Sep 18, 2026