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Vacutainer Brand Plus Serum & Sst Tubes

by Becton Dickinson Vacutainer Systems 510(k)

Active United States

510(k) K960250

Overview

The Vacutainer Brand Plus Serum & Sst Tubes are used for blood collection and serum separation. They are coated with silicone and micronized silica particles to accelerate clotting. The tubes contain a clot activator and gel separator for reliable serum collection.

The tubes are supplied sterile and are ideal for use in clinical labs. They are available in sizes such as 3.5 mL PET tubes and 10 ml tubes. The tubes are used for serum determinations in chemistry, blood donor screening, and infectious disease testing. The device has received FDA 510K authorization.

AI-generated from registry data, 24 Sep 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK960250 Date29 Mar 1996ClearedStatusActive

Coverage

1 jurisdiction

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

United States — FDA 510(k) Active

Recalls

3 recalls · FDA

  • 2 recalls, same reason

    • Terminated Z-2629-2014 FDA Class II initiated 23 Jun 2014
    • Terminated Z-2631-2014 FDA Class II initiated 23 Jun 2014

    Products were held at improper storage temperature

    • Terminated Z-0052-05 FDA Unclassified (pre-2012) initiated 20 Aug 2004

    "Please be aware tht this not a new recall. The firm has taken action; but, due to administrative issues additional products are now being classified by the agency". There is an apparent bias in the determination of Total T3, Total T4, HBsAg, Folate BA, VB 12, BR, FSH and Cortisol hormones used to determine thyroid disease states, and adrenal gland function. The immunoassay results are high when

Specification

510(k)

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

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Questions

  • What are the Vacutainer Brand Plus Serum & SST Tubes used for?

    The tubes are used for blood collection and serum separation, ideal for clinical labs, chemistry, blood donor screening, and infectious disease testing.

  • How are the Vacutainer Brand Plus Serum & SST Tubes supplied?

    The tubes are supplied sterile, coated with silicone and micronized silica particles to accelerate clotting, and contain a clot activator and gel separator.

  • What sizes are the Vacutainer Brand Plus Serum & SST Tubes available in?

    The tubes are available in sizes such as 3.5 mL PET tubes and 10 ml tubes, making them suitable for various clinical applications.

  • Are the Vacutainer Brand Plus Serum & SST Tubes single-use or reusable?

    The tubes are intended for single-use, as they are supplied sterile and designed for reliable serum collection in clinical settings.