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Acs Ckmb II Immunoassay

by Ciba Corning Diagnostics Corp.

510(k) K962126

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

5 closed

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 NumberK962126 Date21 Jun 1996ClearedStatusActive

Recalls

5 recalls · FDA

  • 5 recalls, same reason

    • Terminated Z-0114-2019 FDA Class II initiated 24 Jul 2018
    • Terminated Z-0117-2019 FDA Class II initiated 24 Jul 2018
    • Terminated Z-0113-2019 FDA Class II initiated 24 Jul 2018
    • Terminated Z-0116-2019 FDA Class II initiated 24 Jul 2018
    • Terminated Z-0115-2019 FDA Class II initiated 24 Jul 2018

    A potential bias was identified with certain kits compared to the internal standards.

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  • Withdrawn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
JHS
Device Class
Class II
Regulation
21 CFR Part 862.1215
Advisory Committee
Clinical Chemistry
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 21 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 Acs Ckmb II Immunoassay is a two-site chemilumometric sandwich immunoassay designed to detect CK-MB concentration in serum or plasma samples. It utilizes a monoclonal mouse anti-CK-MB antibody labeled with acridinium ester and a monoclonal mouse anti-CK-BB antibody coupled to paramagnetic particles to measure relative light units.

This device is intended for automated operation on Ciba Corning ACS:180 systems. It has received FDA 510(k) clearance as a traditional premarket notification under the clinical chemistry medical specialty.

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Questions

AI-generated answers, 21 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 intended use of the ACS CKMB II Immunoassay?

    This device is a two-site chemilumometric sandwich immunoassay used to detect the concentration of CK-MB in human serum or plasma samples.

  • Which systems are compatible with this immunoassay?

    The ACS CKMB II Immunoassay is specifically designed for automated operation on Ciba Corning ACS:180 systems to ensure consistent measurement of relative light units.

  • How does the assay detect CK-MB concentrations?

    The assay utilizes a monoclonal mouse anti-CK-MB antibody labeled with acridinium ester and a monoclonal mouse anti-CK-BB antibody coupled to paramagnetic particles to measure relative light units, which correspond to the CK-MB concentration.

  • What is the regulatory status of this device?

    The ACS CKMB II Immunoassay has received FDA 510(k) clearance as a traditional premarket notification under the clinical chemistry medical specialty, classified as a class 2 device.