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ADVIA Chemistry CardioPhase High Sensitivity C-Reactive Protein Calibrators

by Siemens Healthcare Diagnostics, Inc.

510(k) K081294

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 5 Oct 2026. What this means

Regulatory status

as of registry sync 5 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK081294 Date29 Jul 2008ClearedStatusActive

Recalls

2 recalls · FDA

    • Terminated Z-1260-2020 FDA Class II initiated 19 Nov 2019 on shared 510(k) K081294

    Atellica and ADVIA hsCRP calibrator accuracy has drifted away from the reference materials (ERM-DA470/IFCC), which is causing a high bias on QC and patient sample recovery.

    • Terminated Z-1261-2020 FDA Class II initiated 19 Nov 2019 on shared 510(k) K081294

    Atellica CH: The Atellica CH High Sensitivity CReactive Protein Calibrator (hsCRP CAL) is for in vitro diagnostic use in calibrating the hsCRP assay using the Atellica CH Analyzer.

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  • Withdrawn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)

Full name
Advia Chemistry Cardiophase High Sensitivity C-Reactive Protein (Hscrp), Calibrators
510(k) Number
FDA Product Code
NQD
Device Class
Class II
Regulation
21 CFR Part 866.5270
Advisory Committee
Immunology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 1 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The ADVIA Chemistry CardioPhase High Sensitivity C-Reactive Protein Calibrators are in vitro diagnostic calibrators classified under Cardiac C-Reactive Protein, Antigen, Antiserum, and Control. These calibrators are designed to establish reference standards for quantitative measurement of high-sensitivity C-reactive protein (hsCRP) in blood samples, aiding in cardiac risk assessment and cardiovascular disease prognosis.

Supplied as a set for use with ADVIA Chemistry systems, these calibrators are intended for laboratory calibration of the CardioPhase hsCRP assay method. They are intended for single-use and are not sterile, requiring proper handling and storage as per manufacturer guidelines. The product holds an FDA 510(k) clearance under the Immunology advisory committee classification, with a device classification of Class II (NQD).

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Questions

AI-generated answers, 1 Oct 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 purpose of the ADVIA Chemistry CardioPhase High Sensitivity C-Reactive Protein Calibrators?

    These calibrators are designed to establish accurate reference standards for quantitative measurement of high-sensitivity C-reactive protein (hsCRP) in blood samples. hsCRP is a key biomarker used in cardiac risk assessment and cardiovascular disease prognosis, helping laboratories ensure reliable assay performance on ADVIA Chemistry systems.

  • Are the ADVIA Chemistry CardioPhase hsCRP Calibrators intended for single-use or reuse?

    The calibrators are explicitly intended for single-use only. This design minimizes contamination risk and ensures consistent measurement accuracy, as reuse could compromise sterility and integrity of the calibrator material.

  • Do these calibrators require sterile handling, and if not, how should they be stored?

    The ADVIA Chemistry CardioPhase hsCRP Calibrators are not sterile, so they must be handled in a clean environment to prevent contamination. Storage should follow manufacturer guidelines, typically in a cool, dry place away from direct light until use, to preserve stability and accuracy.

  • Which ADVIA Chemistry systems are compatible with these calibrators?

    These calibrators are specifically supplied as a set for use with ADVIA Chemistry systems only. They are not interchangeable with other platforms or analyzers, ensuring optimal performance and calibration for the CardioPhase hsCRP assay method.

  • What regulatory clearance does this product hold, and how does it classify under FDA guidelines?

    The ADVIA Chemistry CardioPhase hsCRP Calibrators hold FDA 510(k) clearance under the Immunology advisory committee classification. They are classified as Class II (Non-significant risk, NQD) devices, indicating they undergo rigorous review for safety and effectiveness in diagnostic use.