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BD MiniDraw Capillary Blood Collection System with BD MiniDraw SST Capillary Blood Collection Tube

by Becton, Dickinson and Company

510(k) K252378

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 25 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK252378 Date10 Apr 2026ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 25 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
JKA
Device Class
Class II
Regulation
21 CFR Part 862.1675
Advisory Committee
Clinical Chemistry
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The BD MiniDraw Capillary Blood Collection System with BD MiniDraw SST Capillary Blood Collection Tube is a capillary blood collection device designed for the collection, separation, and processing of small blood samples. It is intended for use with capillary blood from adult patients (aged 18 years and older) and includes a serum separator tube (SST) for serum analysis.

This system is supplied as a single-use, non-sterile device for in-vitro diagnostic use, adhering to FDA clearance under 510(k) K252378. The BD MiniDraw SST tube is intended for serum separation and storage of collected blood samples, facilitating transport to laboratory settings for clinical chemistry testing. The device is regulated under the Clinical Chemistry advisory committee classification and is not intended for MRI use.

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Questions

AI-generated answers, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the BD MiniDraw Capillary Blood Collection System designed for, and who is it intended for?

    The BD MiniDraw Capillary Blood Collection System is designed specifically for collecting, separating, and processing small blood samples from adult patients aged 18 years and older. It includes a serum separator tube (SST) to facilitate serum analysis, making it suitable for clinical chemistry testing in laboratory settings.

  • Is the BD MiniDraw Capillary Blood Collection System sterile, and how is it supplied?

    The BD MiniDraw Capillary Blood Collection System is supplied as a single-use, non-sterile device. This means it is intended for one-time use per patient and should not be reused or resterilized. It is packaged for in-vitro diagnostic use, ensuring compatibility with clinical workflows.

  • What types of blood samples can be processed with this system, and how is the collected sample handled?

    This system is designed exclusively for capillary blood collection from adult patients. The included BD MiniDraw SST tube separates serum from the blood sample, allowing for stable storage and transport to laboratories for clinical chemistry testing. The serum separator ensures the sample remains intact for accurate diagnostic analysis.

  • How is the regulatory status of this device determined, and what advisory committee oversees its classification?

    The BD MiniDraw Capillary Blood Collection System holds FDA clearance under 510(k) K252378, classified as substantially equivalent to a predicate device. Its regulatory classification falls under the Clinical Chemistry advisory committee (CH), which reviews submissions for in-vitro diagnostic devices used in chemistry testing. This ensures compliance with FDA standards for diagnostic accuracy and safety.