BD Vacutainer Trace Element Serum Plus Tube and BD Vacutainer Trace Element K2EDTA Plus Tube, Models 368380/368381

• • Terminated Z-2632-2014 FDA Class II ·initiated 23 Jun 2014

  Products were held at improper storage temperature

510(k) Number

K041071 ↗

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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• What types of blood specimens can be collected with each tube model?

  The Serum Plus Tube (model 368380) is designed to collect serum, meaning blood is allowed to clot before separation, while the K2EDTA Plus Tube (model 368381) contains potassium oxalate and potassium EDTA to preserve plasma, so it is used when plasma is required for trace element analysis. This distinction follows directly from the device description.

• Are the tubes intended for single or multiple uses, and how are they supplied?

  Both tube models are supplied as sterile, single‑use plastic tubes made of PET. The description explicitly states they are “sterile, single‑use,” indicating they are not intended to be reused after a collection.

• What features of the tube interior help ensure accurate trace element results?

  The interior is silicone‑coated and contains micronized silica particles. The silicone coating reduces adsorption of trace elements to the tube wall, and the silica particles promote rapid clotting, minimizing red blood cell adherence and thus preserving the true concentration of trace elements for analysis.

• How is the regulatory clearance of these tubes described?

  The devices are cleared under FDA 510(k) (K041071) with a “Special” clearance type and are classified in the Clinical Chemistry advisory committee category. This information is taken from the authorization and advisory committee fields in the data, and no other regulatory status is implied.