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Access Cortisol Assay (Modification)

by Bio-Rad Laboratories, Inc. 510(k)

Active United States

510(k) K954733

Overview

The ACCESS CORTISOL ASSAY (MODIFICATION) is a radioimmunoassay device used for the quantitative determination of cortisol levels in human serum, plasma, and urine. It is designed for clinical chemistry applications and is part of the Access Immunoassay Systems.

The device is supplied as a single-use assay kit and is intended for in vitro diagnostic use. It is not reusable and requires proper storage conditions as specified by the manufacturer. The assay is cleared under FDA 510(k) authorization (K954733) as a Class 2 device.

AI-generated from registry data, 1 Oct 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK954733 Date5 Dec 1995ClearedStatusActive

Coverage

1 jurisdiction

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

United States — FDA 510(k) Active

Recalls

1 recall · FDA

    • Terminated Z-2621-2010 FDA Unclassified (pre-2012) initiated 17 Feb 2010

    The recall was initiated by Beckman Coulter after the firm confirmed customer reports that the affected lot of Access Cortisol reagent (REF 33600) identified above may produce suppressed patient results. Beckman Coulter also confirmed customer reports that the two lots of Access Progesterone reagent (REF 33550) identified above may produce suppressed patient results and an increased incidence of I

Specification

510(k)

510(k) Number
FDA Product Code
CGR
Device Class
Class II
Regulation
21 CFR Part 862.1205
Advisory Committee
Clinical Chemistry
FDA Decision
SESE Substantially Equivalent

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Questions

  • What is the ACCESS CORTISOL ASSAY (MODIFICATION) used for?

    The ACCESS CORTISOL ASSAY (MODIFICATION) is used for the quantitative determination of cortisol levels in human serum, plasma, and urine as part of clinical chemistry applications, enabling in vitro diagnostic testing of cortisol concentrations.

  • How is the ACCESS CORTISOL ASSAY (MODIFICATION) supplied and is it reusable?

    The device is supplied as a single-use assay kit and is not reusable; it is intended for one-time in vitro diagnostic use only, requiring proper storage as specified by the manufacturer to maintain assay integrity.

  • What regulatory authorization does the ACCESS CORTISOL ASSAY (MODIFICATION) have?

    The ACCESS CORTISOL ASSAY (MODIFICATION) is cleared under FDA 510(k) authorization (K954733) as a Class 2 device, indicating it was found substantially equivalent to a legally marketed predicate device.