Skip to content

Ck-Mb and Ck-Mb Calibrators on the Access Immunoassay Systems, Models 386371 and 386372

by Beckman Coulter, Inc.

510(k) K030012

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) K030012↗

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 · Special NumberK030012 Date17 Jan 2003ClearedStatusActive
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  • Withdrawn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
JHX
Device Class
Class II
Regulation
21 CFR Part 862.1215
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 CK-MB and CK-MB Calibrators for Access Immunoassay Systems are in vitro diagnostic reagents designed for the quantitative measurement of creatine kinase-MB isoenzyme levels in serum or plasma. These calibrators are used in conjunction with fluorometric methods to ensure accurate assay performance and calibration on the Access Immunoassay Systems, Models 386371 and 386372.

These calibrators are intended for use in clinical chemistry laboratories and are supplied as single-use reagents. They are regulated under the In Vitro Diagnostic Regulation (IVDR) and have received FDA 510(k) clearance as substantially equivalent to a predicate device. Storage and handling conditions must adhere to manufacturer guidelines to maintain stability and accuracy, ensuring reliable diagnostic results.

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 chemistry applications are these CK-MB calibrators specifically designed for, and how do they work?

    These CK-MB calibrators are designed for quantitative measurement of creatine kinase-MB isoenzyme levels in serum or plasma using the Access Immunoassay Systems (Models 386371 and 386372). They utilize fluorometric methods to ensure accurate calibration and reliable assay performance in clinical chemistry laboratories, helping to diagnose conditions like myocardial infarction by confirming cardiac-specific enzyme levels.

  • Are these calibrators single-use, and if so, why is that important for clinical workflows?

    Yes, these CK-MB calibrators are supplied as single-use reagents. This design ensures precision and consistency in diagnostic results, as each vial is unopened and uncontaminated, reducing the risk of carryover or cross-contamination between tests. Single-use also aligns with best practices for maintaining sterility and accuracy in clinical chemistry workflows.

  • What storage and handling requirements must be followed to maintain the stability and accuracy of these calibrators?

    While the exact storage conditions aren’t detailed here, the manufacturer’s guidelines must be strictly followed to preserve stability and accuracy. Typically, such reagents require refrigeration (e.g., 2–8°C) and protection from light, as improper storage can degrade performance. Always refer to the included instructions for the full protocol to ensure reliable diagnostic results.

  • Are these calibrators compatible with any other immunoassay systems besides the Access Immunoassay Systems (Models 386371 and 386372)?

    No, these CK-MB calibrators are explicitly designed for use *only* with the Access Immunoassay Systems, Models 386371 and 386372. They are not intended for other systems, as their formulation and calibration are tailored to these specific platforms for accurate fluorometric measurement of CK-MB levels.

  • What regulatory pathways have these calibrators undergone, and how does that affect their use in clinical settings?

    These calibrators have received FDA 510(k) clearance under the Special Review pathway, demonstrating they are substantially equivalent to a predicate device. They are also compliant with the In Vitro Diagnostic Regulation (IVDR) in the EU. This regulatory clearance ensures they meet stringent performance and safety standards, giving clinicians confidence in their reliability for diagnosing cardiac-related conditions in clinical chemistry labs.