BD Preset™ and BD A-Line™ Arterial Blood Collection Syringes
K260128 · Becton, Dickinson and Company · JKA · Apr 15, 2026 · Clinical Chemistry
Device Facts
Record ID
K260128
Device Name
BD Preset™ and BD A-Line™ Arterial Blood Collection Syringes
Applicant
Becton, Dickinson and Company
Product Code
JKA · Clinical Chemistry
Decision Date
Apr 15, 2026
Decision
SESE
Submission Type
Special
Regulation
21 CFR 862.1675
Device Class
Class 2
Indications for Use
The BD Preset™ and BD A-Line™ Arterial Blood Collection Syringes are sterile, single-use, in vitro diagnostic medical devices specifically intended to be used for the collection and containment of whole blood specimens for the purpose of in vitro diagnostic testing which may include: pH, blood gases, electrolytes (including ionized calcium), metabolites, co-oximetry. The device is intended to be used by trained healthcare professionals.
Device Story
Plastic needleless syringes for arterial/venous blood collection; internal barrel coated with calcium-balanced lithium heparin anticoagulant. BD Preset™ features dual-mode functionality: preset mode with automatic venting for arterial pressure-driven filling, or manual aspiration. BD A-Line™ supports manual aspiration only. Used by trained healthcare professionals in clinical settings. Syringes include graduated barrel, plunger with stopper, and tip cap. Output is a sealed blood specimen for laboratory analysis. Benefits include standardized collection, anticoagulation, and reduced risk of pre-analytical errors in blood gas/electrolyte testing.
Clinical Evidence
No clinical data submitted. Substantial equivalence supported by bench performance testing (tip cap leakage, plunger activation/separation forces, seal integrity, ship testing) and biocompatibility testing (cytotoxicity, hemocompatibility, irritation, sensitization, systemic toxicity, pyrogenicity, extractables/leachables).
Indicated for trained healthcare professionals to collect and contain whole blood specimens for in vitro diagnostic testing (pH, blood gases, electrolytes, metabolites, co-oximetry). No specific patient population or contraindications defined.
Regulatory Classification
Identification
A blood specimen collection device is a device intended for medical purposes to collect and to handle blood specimens and to separate serum from nonserum (cellular) components prior to further testing. This generic type device may include blood collection tubes, vials, systems, serum separators, blood collection trays, or vacuum sample tubes.
Predicate Devices
BD Preset™ and BD A-Line™ Blood Collection Syringe (K022426)
Submission Summary (Full Text)
{0}
FDA U.S. FOOD & DRUG ADMINISTRATION
# SPECIAL 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY
## I Background Information:
A 510(k) Number
K260128
B Applicant
Becton, Dickinson and Company
C Proprietary and Established Names
BD Preset™ and BD A-Line™ Arterial Blood Collection Syringes
D Regulatory Information
| Product Code(s) | Classification | Regulation Section | Panel |
| --- | --- | --- | --- |
| JKA | Class II | 21 CFR 862.1675 - Blood Specimen Collection Device | CH - Clinical Chemistry |
## II Review Summary:
This 510(k) submission contains information/data on modifications made to the submitter's own CLASS II device requiring 510(k). The following items are present and acceptable.
1. The name and 510(k) number of the SUBMITTER'S previously cleared device. BD Preset™ and BD A-Line™ Blood Collection Syringe, K022426.
2. Submitter's statement that the INDICATIONS FOR USE/INTENDED USE of the modified device as described in its labeling HAS NOT CHANGED along with the proposed labeling which includes instructions for use, package labeling, and, if available, advertisements or promotional materials (labeling changes are permitted as long as they do not affect the intended use).
3. A description of the device MODIFICATION(S), including clearly labeled diagrams, engineering drawings, photographs, user's and/or service manuals in sufficient detail to
Food and Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993-0002
www.fda.gov
{1}
demonstrate that the FUNDAMENTAL SCIENTIFIC TECHNOLOGY of the modified device has not changed. This change was for the following:
- Material changes to the resin of the syringes, the tip cap and stopper and the primary and tertiary packaging.
4. Comparison Information (i.e., similarities and differences) to the submitter's legally marketed predicate device including, labeling, intended use, and physical characteristics.
5. A Design Control Activities Summary which includes:
a) Identification of Risk Analysis method(s) used to assess the impact of the modification on the device and its components, and the results of the analysis.
b) Based on the Risk Analysis, an identification of the verification and/or validation activities required, including methods or tests used and acceptance criteria to be applied.
The labeling for this modified subject device has been reviewed to verify that the indication/intended use for the device is unaffected by the modification. In addition, the submitter's description of the particular modification(s) and the comparative information between the modified and unmodified devices demonstrate that the fundamental scientific technology has not changed. The submitter has provided the design control information as specified in The New 510(k) Paradigm and on this basis, I recommend the device be determined substantially equivalent to the previously cleared (or their preamendment) device.
K260128 - Page 2 of 2
