Skip to content

Access 25(OH) Vitamin D Total for Use on the Access 2 Immuno. Syst., Access 25(OH) Vitamin D Total Calibrators for Use on the Access 2 Immuno. Syst

by Beckman Coulter, Inc.

510(k) K142373

Active European Union and United States

CE IVDR 510(k)

Valid until

Not listed

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 6 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K142373↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, FDA 510(k), synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE 510(k) Substantially Equivalent · Traditional NumberK142373 Date22 Dec 2014ClearedStatusActive
European UnionCE/IVDR EUDAMED Number— Date—StatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 6 Oct 2026.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/IVDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · 510(k)

510(k) Number
FDA Product Code
MRG
Device Class
Class II
Regulation
21 CFR Part 862.1825
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 Access 25(OH) Vitamin D Total is a vitamin D total immunoassay system designed for quantitative measurement of 25-hydroxyvitamin D in human serum or plasma. It operates on the Access 2 Immunoassay System, providing clinical laboratory results to assess vitamin D status, which is critical for diagnosing deficiencies, monitoring treatment, and evaluating metabolic bone diseases.

This device is intended for use in clinical chemistry laboratories and is supplied as a reagent kit for in vitro diagnostic use. It requires calibration using the provided Access 25(OH) Vitamin D Total Calibrators and is not single-use; components may be reused per manufacturer instructions. The system is not MRI-compatible, and storage conditions must adhere to the manufacturer’s guidelines to maintain stability and performance. Authorisations include FDA 510(k) clearance and IVDR compliance under regulation number 862.1825.

Other devices from Beckman Coulter, Inc.

See all devices from Beckman Coulter, Inc. →

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 clinical purpose does the Access 25(OH) Vitamin D Total immunoassay system serve in a lab setting?

    The Access 25(OH) Vitamin D Total immunoassay system is designed for quantitative measurement of 25-hydroxyvitamin D in human serum or plasma. This measurement helps clinicians assess vitamin D status, which is essential for diagnosing deficiencies, monitoring treatment progress, and evaluating metabolic bone diseases. It provides objective data to support patient care decisions in clinical chemistry laboratories.

  • How is the Access 25(OH) Vitamin D Total system supplied, and is it single-use?

    The system is supplied as a reagent kit for in vitro diagnostic use, intended for use on the Access 2 Immunoassay System. It is not single-use; components can be reused according to the manufacturer’s instructions. Calibration requires the use of the provided Access 25(OH) Vitamin D Total Calibrators, which are also part of the kit.

  • What regulatory pathways has this device undergone, and where is it authorized for use?

    The Access 25(OH) Vitamin D Total system has received FDA 510(k) clearance and is compliant with the In Vitro Diagnostic Regulation (IVDR) under regulation number 862.1825. These authorizations confirm its compliance with U.S. and EU regulatory standards for in vitro diagnostic devices, ensuring its suitability for clinical chemistry laboratories.

  • Are there any special storage requirements for this device, and can it be used in an MRI environment?

    The device must be stored according to the manufacturer’s guidelines to maintain stability and performance. The Access 25(OH) Vitamin D Total system is explicitly noted as not MRI-compatible, meaning it should not be used or stored in an MRI environment due to potential interference or safety risks.