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Acs Cortisol Immunoassay

by Ciba Corning Diagnostics Corp.

510(k) K962559

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

1 ongoing

This device is named in the recall

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 10 Oct 2026. What this means

Regulatory status

as of registry sync 10 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK962559 Date5 Nov 1996ClearedStatusActive

Recalls

2 recalls · 1 ongoing · FDA

    • Ongoing Z-1505-2023 FDA Class II initiated 16 Mar 2023

    There is a negative bias with urine patient samples and urine cortisol Quality Control (QC) results intermittently out of range low.

    • Terminated Z-1390-2012 FDA Not yet classified initiated 6 Mar 2012

    Cortisol Assay reagent kit lots do not meet onboard stability and calibration interval claims

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  • Withdrawn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
JFT
Device Class
Class II
Regulation
21 CFR Part 862.1205
Advisory Committee
Clinical Chemistry
FDA Decision
SESE Substantially Equivalent

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