Becton, Dickinson and Company · Class II · Cleared Apr 10, 2026
| K-number | K252378 |
| Device name | BD® MiniDraw Capillary Blood Collection System with BD® MiniDraw SST Capillary Blood Collection Tube |
| Applicant | Becton, Dickinson and Company |
| Product code | JKA |
| Device class | Class II |
| Decision date | Apr 10, 2026 |
| Decision | Substantially Equivalent |
| Regulation | 862.1675 |
The BD® MiniDraw™ Capillary Blood Collection System with SST™ Tube is a finger-stick blood collection device designed to collect, separate, transport, and store capillary blood samples from individuals 18 years and older for clinical testing. It standardizes capillary blood collection for trained healthcare workers (phlebotomists, clinicians, pharmacists, pharmacy technicians) in ancillary healthcare facilities and clinical environments, delivering serum samples for measurement of 16 specific analytes including albumin, glucose, potassium, and aspartate aminotransferase.
The subject device is identical to the predicate device in design, materials, dimensions (13×40 mm), single-use non-sterile format, cap-down centrifugation method, and use of a clot activator with gel separator. Both use polypropylene containers with methylacrylonitrile-butadiene-styrene collectors and thermoplastic elastomer caps, and include a finger sleeve, sizing tool, tube adapter, and cap removal tool. The primary difference is that the subject device adds three analytes (AST, potassium, and glucose) to the predicate's indication for use.
ISO 20916:2019 (clinical performance studies), ISO 14155:2011 (clinical investigation), EN ISO 14971:2019 (risk management), ANSI/AAMI/IEC 62366-1:2015 (usability), ANSI AAMI HE75:2009 (human factors), ASTM D4169-22 (shipping container testing), ASTM F1980-21 (accelerated aging of sterile barriers), and ISO 11607-1:2019 (packaging for sterilized medical devices).
The subject device is substantially equivalent to the predicate because it shares identical intended use, principle of operation, and technological characteristics. The addition of three analytes (AST, potassium, glucose) is supported by clinical performance testing demonstrating that results are clinically equivalent to both capillary and venous comparator tubes. Non-clinical and clinical testing confirms the device meets applicable performance requirements, and these differences do not raise new questions of safety or effectiveness.
View the full FDA submission: accessdata.fda.gov