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Access Estradiol Calibrators, Model 33545

by Beckman Coulter, Inc.

510(k) K080166

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 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K080166↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE 510(k) Substantially Equivalent · Special NumberK080166 Date19 Mar 2008ClearedStatusActive
European UnionCE/IVDR EUDAMED Number— Date—StatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 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  • Withdrawn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)

Full name
Access Estradiol Calibrators on the Access Immunoassay Systems, Model 33545
510(k) Number
FDA Product Code
JIT
Device Class
Class II
Regulation
21 CFR Part 862.1150
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 Estradiol Calibrators, Model 33545, are secondary calibrators designed for immunoassay systems. They provide reference standards to establish the quantitative relationship between measured estradiol concentrations and assay signals on the Access Immunoassay Systems, ensuring accurate assay performance.

These calibrators are intended for use in clinical chemistry laboratories with the Access 2, UniCel DxI 600/800, or DxI 9000 systems. Supplied as single-use reagents, they require adherence to manufacturer instructions for frequency and application as outlined in the assay package insert. Authorized under FDA 510(k) and IVDR compliance, they are classified as Class II medical devices under regulation number 862.1150.

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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 immunoassay systems are these calibrators designed to work with, and why is compatibility important?

    The Access Estradiol Calibrators (Model 33545) are specifically designed for use with Beckman Coulter’s Access Immunoassay Systems, including the Access 2, UniCel DxI 600/800, and DxI 9000. Compatibility is critical because these calibrators establish the quantitative relationship between estradiol concentrations and assay signals *only* for these systems. Using them with other systems could compromise accuracy and reliability of estradiol measurements, potentially leading to incorrect clinical interpretations.

  • Are these calibrators single-use, and if so, what does that mean for laboratory workflow?

    Yes, these calibrators are single-use reagents. This means each vial is intended for one calibration run, after which it should be discarded. Laboratories must plan their workflow accordingly—ordering sufficient quantities to avoid interruptions, storing them properly to maintain stability, and following the manufacturer’s instructions for frequency of use as outlined in the assay package insert to ensure consistent assay performance.

  • What regulatory pathways have these calibrators undergone, and what does that imply for their use in clinical settings?

    The Access Estradiol Calibrators (Model 33545) are authorized under both the FDA’s 510(k) pathway and the In Vitro Diagnostic Regulation (IVDR) in the EU. This implies they have undergone rigorous review to demonstrate safety, performance, and equivalence to prior generations of calibrators for estradiol assays. Clinicians and laboratories can rely on their compliance with these frameworks, though local regulatory requirements (e.g., FDA clearance or CE marking) should always be verified before use.

  • How should these calibrators be stored, and why is proper storage important for their functionality?

    While the exact storage conditions aren’t detailed in the provided data, calibrators like these typically require refrigeration (e.g., 2–8°C) to preserve stability and accuracy. Proper storage is critical because estradiol calibrators are sensitive to temperature fluctuations, light exposure, or freeze-thaw cycles, which can degrade their reference standards. Adhering to manufacturer guidelines ensures the calibrators remain effective for their intended single-use application, preventing inaccurate assay results.