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Dimension Cki Flex Reagent Cartridge, Dimension Mbi Flex Reagent Cartridge, And Cki/Mbi Calibrator, Models DF38, DF32

by Siemens Healthcare Diagnostics

510(k) K081731

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

1 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 NumberK081731 Date29 Aug 2008ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-1653-2018 FDA Class II initiated 29 Jun 2017

    Various assays used to measure different chemical levels in blood, urine, or cerebrospinal fluid may interfere with the drugs sulfasalazine and/or sulfapyridine causing falsely elevated or falsely depressed results.

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  • Withdrawn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

Overview

AI-generated summary, 26 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 Dimension CKI Flex Reagent Cartridge and Dimension MBI Flex Reagent Cartridge are in vitro diagnostic test methods used for the quantitative measurement of creatine kinase and its isoenzymes in human serum and plasma. These cartridges are designed to be used on the Dimension clinical chemistry system to facilitate clinical laboratory analysis.

The system includes the CKI/MBI calibrator and is supplied as a prepackaged test method for use in clinical settings. This device has received FDA 510(k) clearance under the product code CGS and regulation number 862.1215.

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Questions

AI-generated answers, 26 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 are the Dimension CKI and MBI Flex Reagent Cartridges used for?

    These reagent cartridges are in vitro diagnostic test methods designed for the quantitative measurement of creatine kinase and its isoenzymes. They are intended for use with human serum and plasma samples to facilitate clinical laboratory analysis.

  • Which systems are compatible with these reagent cartridges?

    The cartridges are specifically designed to be used on the Dimension clinical chemistry system. They are supplied as a prepackaged test method to ensure integration with the system's analytical workflow.

  • Does this product include a calibrator?

    Yes, the system includes the CKI/MBI calibrator as part of the package. This component is necessary to support the quantitative measurement process on the Dimension clinical chemistry system.

  • What is the regulatory status of these reagent cartridges?

    The Dimension CKI and MBI Flex Reagent Cartridges have received FDA 510(k) clearance. They are classified under regulation number 862.1215 and product code CGS, which pertains to clinical chemistry diagnostic devices.