Becton, Dickinson and Company · Class II · Cleared Mar 13, 2026
| K-number | K252040 |
| Device name | BD Vacutainer® Plasma Separator Tubes (PST), BD Vacutainer® Sodium Heparin Blood Collection Tubes |
| Applicant | Becton, Dickinson and Company |
| Product code | JKA |
| Device class | Class II |
| Decision date | Mar 13, 2026 |
| Decision | Substantially Equivalent |
| Regulation | 862.1675 |
The BD Vacutainer® Plasma Separator Tubes (PST™) and BD Vacutainer® Sodium Heparin Blood Collection Tubes are sterile, single-use, evacuated blood collection devices intended for healthcare professionals to collect, contain, and transport human venous blood specimens and separate plasma for in vitro diagnostic testing. The PST™ tubes are used for chemistry analytes, while the sodium heparin tubes are used for lithium testing.
Both subject and predicate devices are plastic evacuated tubes made from PET (polyethylene terephthalate) with BD Hemogard™ cap assemblies or conventional rubber stoppers. They contain spray-dried lithium or sodium heparin anticoagulant and an inert polymer separator gel (PST™ only). Available in multiple tube dimensions (13×75mm, 13×100mm, 16×100mm) and draw volumes (3–10mL depending on type). Both use gamma irradiation sterilization with 10⁻³ sterility assurance level.
ISO 11137-1:2006/(R)2015, ISO 11137-2:2013, ISO 11137-3:2017, ISO 11737-1:2018, ISO 11737-2:2019, AAMI ST67:2019, EN ISO 14971:2019.
The subject devices have identical intended use, principle of operation, and technological characteristics to the predicate devices (K945952 and K944566). Non-clinical bench testing and analytical/clinical performance testing demonstrated equivalence for draw volume, barrier formation, stopper integrity, tube leakage, centrifugation resistance, and chemistry analyte performance. Minor changes to indications for use wording and shelf-life do not represent new intended uses and do not raise safety or effectiveness concerns.
View the full FDA submission: accessdata.fda.gov