# K100293: Advia Centaur Calibrator 30, Models 10379811/10379810

- Pathway: 510(k) (Abbreviated)
- Applicant: Siemens Heatlhcare Diagnostics, Inc.
- Decided: Mar 19, 2010 after 45 days
- Product code: JIT (Calibrator, Secondary)
- Device class: 2
- Regulation: 21 CFR 862.1150
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K932715 (1993). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K932715: Ciba Corning Acs Estradiol Immunoassay, Ciba Corning Diagnostics Corp. (1993) Summary page 1.
- K954697: Ciba Corning Acs Estradiol-6 Assay, Ciba Corning Diagnostics Corp. (1995) Summary page 1.

## Recalls of this device
- Jun 7, 2017 · Class II · Z-0515-2018: 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 Calib

## Indications for use
For in vitro diagnostic use in calibrating the following assays using ADVIA Centaur Systems. Enhanced Estradiol (eE2) ADVIA Centaur calibrator 30 is a device intended for medical purposes for use in Estradiol Assay to establish points of reference that are used in the determination of values in the measurement of Estradiol in human serum, Heparinized and EDTA Plasma.

Source page: https://510kreport.com/device/K100293
Methodology: https://510kreport.com/methodology