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Enzyme II Calibrator

by Siemens Healthcare Diagnostics, Inc.

510(k) K103836

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

2 closed

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source 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 Substantially Equivalent · Traditional NumberK103836 Date16 Feb 2011ClearedStatusActive

Recalls

2 recalls · FDA

    • Terminated Z-1712-2017 FDA Class III initiated 23 Feb 2017 on shared 510(k) K103836

    Siemens Healthcare Diagnostics has confirmed a positive bias of up to 41% in quality control and patient results for Aspartate Aminotransferase (AST) and Aspartate Aminotransferase concentrated (AST_c) assays following calibration with Advia Chemistry Enzyme 2 Calibrator lots 6JD079 and 6MD042.

    • Terminated Z-1217-2017 FDA Class III initiated 5 May 2016

    Complaints of positive shift of patient and QC results when the ALTI assay is calibrated with the Dimension Enzyme II calibrator. Internal investigation has confirmed that patient samples and QC material demonstrate a shift of up to 10% in comparison to results obtained using earlier calibrator lots.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

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  • Withdrawn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
JIT
Device class
Class II
Regulation
21 CFR Part 862.1150
Advisory committee
Clinical Chemistry
FDA decision
SESE Substantially Equivalent

Overview

AI-generated summary, 25 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 Enzyme II Calibrator is an in vitro diagnostic product for the calibration of Alanine Aminotransferase (ALT) on the Dimension® clinical chemistry system. It is a Class 2 device with product code JIT, cleared through the FDA 510(k) pathway under regulation number 862.1150.

The device is supplied for prescription use only and is distributed throughout the United States. It is provided in a format of 6 x 1.5mL vials for use with the Atellica CH system. No information regarding sterility, single-use or reusable status, MRI safety, storage conditions, or specific indications beyond calibration is provided in the data.

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Questions

AI-generated answers, 25 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 Enzyme II Calibrator used for?

    The Enzyme II Calibrator is an in vitro diagnostic product designed specifically for the calibration of Alanine Aminotransferase (ALT) assays on the Dimension® clinical chemistry system, ensuring accurate measurement of this liver enzyme in patient samples.

  • How is the Enzyme II Calibrator supplied and for which systems is it intended?

    The device is supplied in a format of 6 x 1.5mL vials and is intended for use with the Atellica CH system, which is part of the Dimension® clinical chemistry platform, for prescription use only in the United States.

  • Is the Enzyme II Calibrator sterile or single-use, and what is its regulatory classification?

    The provided data does not include information about sterility, single-use, or reusable status of the Enzyme II Calibrator; however, it is classified as a Class 2 device with product code JIT and was cleared through the FDA 510(k) pathway under regulation number 862.1150.