BD Vacutainer Fluoride Blood Collection Tubes
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K231237 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 Fluoride Blood Collection Tubes are Blood Collection Tubes, Evacuated, with Anticoagulant (FDA Product Code: JKA), designed for the collection of whole blood samples containing sodium fluoride as an anticoagulant and preservative. These tubes are specifically intended for glucose determinations and other biochemical assays requiring fluoride stabilization.
The tubes are supplied as sterile, single-use, evacuated plastic containers made of polyethylene terephthalate (PET) with gray closures. They are intended for use in clinical chemistry settings, adhering to FDA 510(k) clearance (K231237) under the Clinical Chemistry advisory committee. No MRI safety or reusable specifications are indicated in the regulatory data.
Frequently asked questions
What specific types of blood tests are these fluoride tubes designed to stabilize for accurate results?
These BD Vacutainer Fluoride Blood Collection Tubes are specifically designed for glucose determinations and other biochemical assays that require sodium fluoride as a preservative to stabilize the sample. The fluoride prevents glucose degradation, ensuring reliable results for these tests in clinical chemistry settings.
Are these tubes meant for reuse, or are they single-use only?
These BD Vacutainer Fluoride Blood Collection Tubes are explicitly labeled as single-use, sterile evacuated containers. They are not intended for reuse, adhering to standard clinical practice for blood collection tubes to maintain sample integrity and prevent contamination.
What material are the tubes made of, and what color are the caps?
The tubes are made of polyethylene terephthalate (PET), a durable plastic material, and they come with gray-colored closures. This combination ensures compatibility with blood collection procedures while maintaining sample stability.
How are these tubes supplied, and what should I consider when storing them?
These tubes are supplied as sterile, single-use evacuated containers in a ready-to-use format. They should be stored according to manufacturer guidelines, typically in a cool, dry place away from direct sunlight, to preserve sterility and integrity until use.
What regulatory pathway was followed for FDA clearance of these tubes?
The BD Vacutainer Fluoride Blood Collection Tubes were cleared through the FDA’s 510(k) process under the Clinical Chemistry advisory committee (CH). The clearance type is traditional, and the decision was made under the product code JKA, confirming they are substantially equivalent to a predicate device.
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, BD Vacutainer™ Plastic Blood Collection Tubes with Fluoride: Hemogard™, BD (company) - Wikipedia, BD Medical - Becton Dickinson for Fluoride Blood Collection Tubes
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K231237 | Class II | Active |
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Manufacturer
- Manufacturer
- Becton, Dickinson and Company
Sources (1)
- FDA 510(k) K231237 24 fields · synced Sep 18, 2026