BD Preset™ and BD A-Line™ Arterial Blood Collection Syringes

The BD Preset™ and BD A-Line™ Arterial Blood Collection Syringes are sterile, single-use plastic syringes with a graduated scale, Luer Slip connection, and tip cap, spray-coated internally with calcium-balanced lithium heparin anticoagulant. They are designed for collection and containment of whole blood specimens for in vitro diagnostic testing (pH, blood gases, electrolytes, metabolites, co-oximetry) and are intended for use by trained healthcare professionals.

The devices are 1 mL plastic needleless syringes with a graduated barrel, plunger with pre-attached stopper, and tip cap. Minor material modifications from the predicate include: BD A-Line™ plunger stopper changed from Styrene Butadiene rubber to polyisoprene (7448/50 Black), tip cap changed to latex-free polyisoprene, and primary packaging changed from foil to plastic with tertiary carton changed from C Flute to B Flute profile. Sterilization remains gamma irradiation at 10⁻⁶ SAL with 2-year shelf life.

EN ISO 13485, EN ISO 14971, EN ISO 10993 series (biocompatibility), EN ISO 7886-1 (hypodermic syringes), EN ISO 11607 (packaging and sterilization), EN 556-1 (sterility), EN ISO 11137 (radiation sterilization), EN 13612 (IVD performance evaluation), and EN ISO 80369-7 (Luer connectors).

The subject device has identical intended use, design, operating principles, and component materials as the predicate (K022426). Although material substitutions occur (plunger stopper, tip cap, packaging), comprehensive bench and biocompatibility testing confirmed these changes do not raise new safety or efficacy questions and do not impact device performance. The device maintains the same anticoagulant, sterilization method, sterility assurance level, and shelf life as the predicate.