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Advia Centaur TSH

by Siemens Healthcare Diagnostics, Inc.

510(k) K141999

Active European Union and United States

CE IVDR 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None ongoing

3 closed

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K141999↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, 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 510(k) Substantially Equivalent · Special NumberK141999 Date22 Apr 2015ClearedStatusActive
European UnionCE/IVDR EUDAMED Number— Date—StatusActive

Recalls

3 recalls · FDA

    • Terminated Z-1537-2017 FDA Class II initiated 2 Feb 2017 on shared 510(k) K141999

    Multiple software issues, which may affect the operation and workflow of the system. Potential for an apparent delay to testing when these issues occur. The software issues affecting the analyzer may impact all analytes available on the ADVIA Centaur XPT System test menu.

    • Terminated Z-2256-2016 FDA Class II initiated 26 May 2016

    Eight (8) issues were identified which may affect the results generated by the system software version.

    • Terminated Z-0072-2017 FDA Class II initiated 28 Apr 2016

    The ADVIA Centaur XPT default setting for the Daily Maintenance Task (Daily Cleaning Procedure) frequency may have the Daily Maintenance Task frequency set to, As needed instead of Daily. Not performing the daily maintenance may impact any assay and can be detected through monitoring of quality control and calibration results. Systems running in a language other than English are not impacted.

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

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/IVDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · 510(k)

510(k) Number
FDA product code
JLW
Device class
Class II
Regulation
21 CFR Part 862.1690
Advisory committee
Clinical Chemistry
FDA decision
SESE Substantially Equivalent

Overview

AI-generated summary, 18 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 Advia Centaur TSH is a radioimmunoassay device for measuring thyroid-stimulating hormone (TSH) levels in serum or plasma. It employs chemiluminescent technology to quantify TSH concentrations, aiding in the diagnosis and monitoring of thyroid disorders such as hypothyroidism, hyperthyroidism, and pituitary dysfunction.

This device is intended for use in clinical chemistry laboratories and is supplied as a reusable system with single-use reagents. It operates under non-invasive conditions and does not require MRI compatibility considerations. The system is authorized under FDA 510K clearance and IVDR compliance, with regulatory classification as a Class II device (862.1690). Storage and handling follow manufacturer guidelines to ensure reagent stability and analytical performance.

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Questions

AI-generated answers, 18 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 types of samples can the Advia Centaur TSH device analyze, and how does it measure thyroid-stimulating hormone (TSH) levels?

    The Advia Centaur TSH device is designed to measure TSH levels specifically in serum or plasma samples. It uses chemiluminescent technology—a highly sensitive method where light emission is proportional to the TSH concentration—to quantify TSH accurately. This aids in diagnosing and monitoring thyroid disorders like hypothyroidism, hyperthyroidism, and pituitary dysfunction.

  • Is the Advia Centaur TSH system reusable, and if so, how are the single-use components handled?

    Yes, the Advia Centaur TSH system itself is reusable, but it requires single-use reagents for each test. This design ensures consistency and sterility per manufacturer guidelines, preventing cross-contamination between samples while maintaining analytical performance.

  • What regulatory pathways does the Advia Centaur TSH follow, and what classification does it hold?

    The device is authorized under FDA 510K clearance (K141999) and complies with the In Vitro Diagnostic Regulation (IVDR). It is classified as a Class II medical device under the regulatory category 862.1690, indicating it has moderate risk and requires specific validation for safety and performance.

  • Are there specific storage or handling requirements for the reagents to ensure their stability and accuracy?

    While the exact storage conditions aren’t detailed in the data, the manufacturer’s guidelines must be followed to maintain reagent stability and analytical performance. This typically includes controlled temperature, protection from light, and proper sealing to prevent degradation before use.