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Cobas Integra Reagent Cassettes & Ancillary Reagents

by Roche Diagnostic Systems, Inc.

510(k) K963292

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 NumberK963292 Date31 Oct 1996ClearedStatusActive

Recalls

2 recalls · FDA

    • Terminated Z-1824-2011 FDA Unclassified (pre-2012) initiated 11 Oct 2010

    Internal investigations have confirmed imprecision and erroneous patient results (up to 35% discrepant results) for specific lots of the Calcium assay. Internal investigations revealed the presence of precipitate in the R2 of the affected calcium reagent lots. The precipitate observed was classified as o-cresolphthalein complexone (o-CPC), a reactive component of the calcium R2. The root cau

    • Terminated Z-1823-2011 FDA Unclassified (pre-2012) initiated 11 Oct 2010

    The firm has recieved complaints of imprecision and erroneous patient results for calcium on the COBAS INTEGRA and COBAS c 501 system using reagent lots 62601901 and 63020401.

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  • Withdrawn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
CIC
Device Class
Class II
Regulation
21 CFR Part 862.1145
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 Cobas Integra Reagent Cassettes & Ancillary Reagents are in vitro diagnostic devices used for automated testing on the Cobas Integra system. They are designed for clinical chemistry assays and utilize absorbance, fluorescence polarization, and ion-selective electrode methodologies.

These reagent cassettes are barcode-identified, preparation-free, and stored on-board at 2-8°C. They are supplied for use in clinical laboratory settings and are authorized under FDA 510(k) clearance K963292.

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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 Cobas Integra Reagent Cassettes & Ancillary Reagents used for?

    These reagent cassettes are in vitro diagnostic devices designed for automated clinical chemistry assays on the Cobas Integra system, utilizing absorbance, fluorescence polarization, and ion-selective electrode methodologies to perform laboratory tests on patient samples.

  • How are the Cobas Integra Reagent Cassettes supplied and stored?

    The reagent cassettes are supplied as barcode-identified, preparation-free units intended for on-board storage at 2-8°C within the Cobas Integra system, ensuring stability and readiness for use in clinical laboratory settings.

  • Are the Cobas Integra Reagent Cassettes single-use or reusable?

    The reagent cassettes are single-use devices; each cassette is designed for one-time use in the automated analyzer and is discarded after the assay is completed, as they contain pre-measured reagents that cannot be replenished or reused.