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

by Beckman Coulter, Inc.

510(k) K142362

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) K142362↗

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 NumberK142362 Date19 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  • Withdrawn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 chemiluminescent immunoassay system designed for the quantitative measurement of total 25-hydroxyvitamin D in human serum or plasma. It operates on the UniCel DxI Immunoassay System, a fully automated platform used in clinical chemistry laboratories for high-throughput diagnostic testing.

This device is intended for in vitro diagnostic use and is supplied as a reagent kit, including calibrators for system calibration. It is classified as a Class II medical device under FDA regulations (21 CFR 862.1825) and has received FDA 510(k) clearance and IVDR conformity. The system requires proper storage at controlled temperatures and is intended for single-use per manufacturer specifications.

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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 clinical application is this device designed for, and how does it work?

    This device, the Access 25(OH) Vitamin D Total, is designed for the quantitative measurement of total 25-hydroxyvitamin D levels in human serum or plasma. It operates as a chemiluminescent immunoassay on the UniCel DxI Immunoassay System, a fully automated platform used in clinical chemistry labs for high-throughput diagnostic testing. The assay helps monitor vitamin D status, which is critical for assessing bone health, immune function, and other metabolic processes.

  • Is this kit single-use, or can it be reused across multiple tests?

    The Access 25(OH) Vitamin D Total kit is intended for single-use per manufacturer specifications. While the UniCel DxI system itself is designed for high-throughput testing, the reagents and calibrators included in this kit are not meant to be reused. This ensures accuracy and sterility for each measurement.

  • What storage conditions are required for this device, and how should it be handled?

    This device requires proper storage at controlled temperatures to maintain its performance. The manufacturer specifies that the kit must be stored under conditions that preserve its integrity, though exact temperature ranges are not detailed in the provided data. Since it is a reagent kit for in vitro diagnostic use, it should be kept in a clean, dry environment, protected from light and contamination, until use.

  • What regulatory pathways has this device undergone, and what does that mean for its use?

    The Access 25(OH) Vitamin D Total has undergone FDA 510(k) clearance and IVDR (In Vitro Diagnostic Regulation) conformity, confirming it meets regulatory standards for safety and effectiveness. The FDA 510(k) clearance indicates it is deemed substantially equivalent to a predicate device, while IVDR compliance ensures it aligns with European diagnostic regulations. These approvals validate its use in clinical settings for measuring vitamin D levels.