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Nichols Advantage Chemiluminescence Cortisol Immunoassay, Model 62-7005

by Nichols Institute Diagnostics

510(k) K984520

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 6 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source 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 Substantially Equivalent · Traditional NumberK984520 Date5 Feb 1999ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 6 Oct 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

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

Overview

AI-generated summary, 1 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Nichols Advantage Chemiluminescence Cortisol Immunoassay, Model 62-7005, is a chemiluminescent immunoassay device classified as a radioimmunoassay for cortisol measurement. It quantifies cortisol concentrations in human serum, EDTA plasma, and urine, enabling diagnostic evaluation of adrenal gland function and related disorders. The assay employs chemiluminescent detection to enhance sensitivity and precision in hormone quantification.

This device is intended for use with the Nichols Advantage Specialty System and is supplied as an in vitro diagnostic test. It is classified under FDA 510(k) clearance (K984520) as substantially equivalent to predicate devices, regulated under 21 CFR 862.1205 for clinical chemistry test systems. The assay is designed for single-use and requires adherence to standard laboratory protocols for handling, storage, and disposal. No MRI safety or sterility specifications are noted in the regulatory data.

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Questions

AI-generated answers, 1 Oct 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 intended use of the Nichols Advantage Cortisol Immunoassay?

    This device is an in vitro diagnostic test used to quantify cortisol concentrations in human serum, EDTA plasma, and urine. It is designed to assist clinicians in the diagnostic evaluation of adrenal gland function and related disorders.

  • Is this cortisol assay intended for multiple uses?

    No, the Nichols Advantage Chemiluminescence Cortisol Immunoassay is designed for single-use. Users must follow standard laboratory protocols for the proper handling and disposal of the test components after the assay is performed.

  • What equipment is required to run this assay?

    This immunoassay is specifically intended for use with the Nichols Advantage Specialty System. It utilizes chemiluminescent detection to provide the sensitivity and precision required for hormone quantification.

  • What is the regulatory status of this device?

    The device has received FDA 510(k) clearance (K984520) and is classified as substantially equivalent to predicate devices under 21 CFR 862.1205 for clinical chemistry test systems.