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ADVIA Centaur Calibrator 30, Models 10379811/10379810

by Siemens Heatlhcare Diagnostics, Inc.

510(k) K100293

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 · Abbreviated NumberK100293 Date19 Mar 2010ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-0515-2018 FDA Class II initiated 7 Jun 2017 on shared 510(k) K100293

    Siemens Healthcare Diagnostics has confirmed a negative bias for ADVIA Centaur Enhanced Estradiol (eE2) on the ADVIA Centaur, ADVIA Centaur XP and ADVIA Centaur XPT systems when calibrating with Calibrator 30 kit lots ending in 21 (C3021) as compared to Calibrator 30 kit lots ending in 20 (C3020).

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  • Withdrawn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, 23 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 device is a calibrator, secondary, intended for use in clinical chemistry. It is designed to calibrate in vitro diagnostic test systems on the ADVIA Centaur platform.

It is supplied as a reagent for use in laboratory settings. The device has received FDA 510(k) clearance under K100293 and is classified as a Class II medical device. It is not indicated as sterile, single-use, or reusable in the provided data, and no MRI safety, storage conditions, or size specifications are stated.

Other devices from Siemens Heatlhcare Diagnostics, Inc.

Questions

AI-generated answers, 23 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 ADVIA Centaur Calibrator 30 used for?

    The ADVIA Centaur Calibrator 30 is a secondary calibrator intended for use in clinical chemistry to calibrate in vitro diagnostic test systems on the ADVIA Centaur platform, ensuring accurate measurement of analytes in patient samples.

  • How is the ADVIA Centaur Calibrator 30 supplied and where is it used?

    The device is supplied as a reagent for use in laboratory settings, specifically designed for use with the ADVIA Centaur system to support calibration of clinical chemistry assays.

  • Is the ADVIA Centaur Calibrator 30 sterile, single-use, or reusable?

    The provided data does not indicate whether the ADVIA Centaur Calibrator 30 is sterile, single-use, or reusable; no specifications regarding sterility or reuse are stated in the device description.