Skip to content

Access Inhibin A Calibrators & Controls

by Beckman Coulter, Inc.

510(k) K070144

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) K070144↗

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 · Traditional NumberK070144 Date1 Feb 2007ClearedStatusActive
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  • Withdrawn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
Inhibin a Calibrators & Controls on the Access Immunoassay Systems
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 Inhibin A Calibrators & Controls are secondary calibrators designed for immunoassay systems. They are used to establish and verify the quantitative measurement of dimeric Inhibin A levels in human serum and plasma, ensuring accurate calibration curves for the Access Immunoassay Systems.

These calibrators and controls are intended for in vitro diagnostic use with the Access Immunoassay Systems and are supplied as liquid reagents. They are regulated under the FDA 510(k) pathway with a Traditional clearance type, classified as Class II devices under the regulation number 862.1150. The product variants include standard levels (e.g., A36098) and are intended for single-use in clinical chemistry settings.

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 is the primary purpose of the Access Inhibin A Calibrators & Controls in a clinical setting?

    The Access Inhibin A Calibrators & Controls are designed to establish and verify the accurate quantitative measurement of dimeric Inhibin A levels in human serum and plasma. They help generate reliable calibration curves for the Access Immunoassay Systems, ensuring precise diagnostic results in clinical chemistry labs.

  • Are these calibrators and controls intended for single-use or repeated use?

    These calibrators and controls are explicitly intended for single-use in clinical chemistry settings. This design ensures consistency and accuracy in measurements, as reuse could compromise sterility and reliability.

  • How are the Access Inhibin A Calibrators & Controls supplied, and what form do they take?

    They are supplied as liquid reagents, specifically formulated for use with the Access Immunoassay Systems. The liquid form allows for precise dispensing and integration into automated immunoassay workflows.

  • What regulatory pathway and classification apply to these calibrators and controls?

    The Access Inhibin A Calibrators & Controls are regulated under the FDA 510(k) pathway with a Traditional clearance type and classified as Class II devices under regulation number 862.1150. They are also compliant with the In Vitro Diagnostic Regulation (IVDR) in the EU, reflecting their global diagnostic use.

  • What types of samples can these calibrators and controls be used to measure Inhibin A levels in?

    These calibrators and controls are specifically intended for use with human serum and plasma samples. They ensure accurate calibration and verification of Inhibin A measurements in these biological matrices for clinical chemistry applications.