BD Vacutainer Serum Separator (SST) Blood Collection Tubes
by Becton, Dickinson and Company
510(k) K230855
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK230855 | Date20 Dec 2023 | StatusActive |
Recalls
No FDA recalls found in the data synced 25 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- JKA
- 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 Serum Separator (SST) Blood Collection Tubes are Serum Separator Tubes (SST) designed for blood collection and serum separation. These tubes contain a clot activator and a gel separator to facilitate the separation of serum from cellular components after centrifugation, ensuring reliable serum collection for clinical testing.
These tubes are supplied sterile, in 3.5 mL PET format with silicone/silica coating, and are intended for single-use in clinical laboratories. Centrifugation at 1000–1300 RCF for 10 minutes (swinging bucket) or 15 minutes (fixed-angle) at room temperature is recommended. The device holds FDA 510(k) clearance (K230855) under the Clinical Chemistry advisory committee classification and is classified under product code JKA.
From the manufacturer
All non-gel separator blood collection tubes, including those that contain heparin, EDTA and non-gel serum tubes can be centrifuged at ≤1300 RCF for 10 minutes. The BD Vacutainer SST and PST gel tubes should be spun at room temperature at a speed of 1000 to 1300 RCF for 10 minutes in a swinging bucket centrifuge and 15 minutes in a fixed-angle centrifuge.
BD Vacutainer® SST™ Tubes (SKU 367983) with clot activator and gel separator for reliable serum collection. 3.5 mL PET tubes, silicone/silica coated, sterile, ideal for clinical labs.
Other devices from Becton, Dickinson and Company
Questions
AI-generated answers, 18 Sep 2026
What is the primary purpose of the BD Vacutainer Serum Separator (SST) Blood Collection Tubes in a clinical lab setting?
The BD Vacutainer Serum Separator (SST) Blood Collection Tubes are designed specifically for blood collection and serum separation. They contain a clot activator and a gel barrier that, after centrifugation, separates serum from blood cells, ensuring a clear serum sample for reliable clinical testing. This makes them ideal for lab work requiring accurate serum analysis.
Are these tubes reusable, or are they intended for single-use only?
These tubes are explicitly intended for single-use in clinical laboratories. The manufacturer emphasizes their sterile packaging and design for one-time use, which helps prevent contamination and ensures consistent performance for accurate serum separation.
What are the recommended centrifugation conditions for these tubes, and why does it matter?
The manufacturer recommends centrifugation at 1000–1300 RCF for 10 minutes (swinging bucket) or 15 minutes (fixed-angle) at room temperature. This range ensures the gel separator fully migrates to the serum-cell interface, creating a clear barrier for reliable serum collection without disturbing cellular components. Deviating from these settings may compromise separation quality.
What size and format are these tubes supplied in, and how does the coating affect their use?
These tubes are supplied in a 3.5 mL PET (polyethylene terephthalate) format with a silicone/silica coating. The coating enhances blood flow and clotting efficiency, reducing hemolysis and ensuring smoother serum separation during centrifugation, which is critical for accurate diagnostic testing.
How should these tubes be stored, and what precautions should be taken before use?
While the data does not specify storage conditions explicitly, as sterile single-use devices, they should be stored in a clean, dry environment protected from extreme temperatures or direct sunlight. Before use, ensure the tube is intact and the seal is unbroken to maintain sterility and prevent contamination, as any breach could compromise the integrity of the sample.