BD Vacutainer Citrate Blood Collection Tubes
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K240455 FDA 510(k)
- FDA Product Code
- GIM 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 Citrate Blood Collection Tubes are Vacuum Sample Tubes with Anticoagulant, designed for collecting whole blood samples. These tubes incorporate sodium citrate as an anticoagulant to prevent clotting, ensuring compatibility with coagulation testing and clinical chemistry assays. They adhere to the nomenclature for blood collection devices intended for laboratory analysis.
These tubes are supplied as single-use, sterile, and non-sterile variants, depending on the specific model. They are classified as Class II medical devices under FDA regulations (862.1675) and are intended for use in clinical chemistry settings. Multiple sizes and capacities are available, including 2.7 mL, and are regulated through FDA 510(k) clearance (K240455) as substantially equivalent to predicate devices. Storage and handling follow standard aseptic practices for blood collection tubes.
Frequently asked questions
Are these tubes intended for reuse or are they single-use only?
The BD Vacutainer® Citrate Blood Collection Tubes are designed for single-use only. This is a standard practice for blood collection tubes to ensure patient safety, sterility, and accurate test results, as reuse could introduce contamination or compromise the integrity of the anticoagulant.
What sizes and capacities are available for these citrate blood collection tubes?
The BD Vacutainer® Citrate Blood Collection Tubes are available in multiple sizes, including a 2.7 mL capacity. The exact range of sizes may vary by model, but the product is listed under multiple FDA registration numbers, indicating availability in several standard volumes for clinical chemistry applications.
Are there sterile and non-sterile versions of these tubes, and how should they be handled?
Yes, these tubes are supplied in both sterile and non-sterile variants, depending on the specific model. Sterile versions require aseptic handling to maintain integrity, while non-sterile versions follow standard blood collection tube handling protocols. Always refer to the packaging instructions for proper storage and use.
What regulatory pathway was followed for FDA clearance of these tubes?
The BD Vacutainer® Citrate Blood Collection Tubes were cleared through the FDA 510(k) process, specifically under the Traditional pathway, and were determined to be substantially equivalent (SESE) to predicate devices. The clearance (K240455) was issued by the FDA’s Clinical Chemistry (CH) advisory committee and falls under product code GIM.
How should these tubes be stored to ensure proper functionality?
Storage follows standard aseptic practices for blood collection tubes. They should be kept in a cool, dry place, protected from direct sunlight and extreme temperatures. Avoid exposure to moisture or contamination, as this could compromise sterility or the anticoagulant properties of the sodium citrate.
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® blood collection tubes | BD, PDF BD Vacutainer® Blood Collection Tubes, BD (company) - Wikipedia, BD Vacutainer™ Plastic Blood Collection Tubes with Sodium Citrate
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K240455 | Class II | Active |
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Manufacturer
- Manufacturer
- Becton, Dickinson and Company
Sources (1)
- FDA 510(k) K240455 24 fields · synced Sep 18, 2026