510(k) · Cleared
Recalled · Class II · 2017Advia Centaur Calibrator 30, Models 10379811/10379810
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Siemens Heatlhcare Diagnostics, Inc. · JIT Calibrator, Secondary
Cleared on Mar 19, 2010 as substantially equivalent to K932715 (Ciba Corning Diagnostics Corp., 1993) and 1 other predicate after a 45-day review. Its family tree reaches back 1 generation to 1993. It has been recalled once.
- Decided
- Mar 19, 2010
- Review
- 45 days
- Class
- Class II
- Product code
- JIT
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 1 generation to K932715 (1993). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK932715 Ciba Corning Acs Estradiol ImmunoassayCiba Corning Diagnostics Corp. · 1993
- This deviceK100293 Advia Centaur Calibrator 30, Models 10379811/10379810Siemens Heatlhcare Diagnostics, Inc. · 2010
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K932715 | Ciba Corning Acs Estradiol Immunoassay | Ciba Corning Diagnostics Corp. | 1993 | — |
| 0 (this device) | K100293 | Advia Centaur Calibrator 30, Models 10379811/10379810 | Siemens Heatlhcare Diagnostics, Inc. | 2010 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in JIT? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K932715 | Ciba Corning Acs Estradiol ImmunoassaySummary page 1…. Panel: Clinical Chemistry F. Predicate Device: The ADVIA Centaur Calibrator 30 is substantially equivalent to the ADVIA Centaur Calibrator E which was cleared under K932715/K954697 G. Device Description: The ADVIA Centaur® Calibrator 30 is a 2 level human plasma based solutions containing varying con… | 1993 |
| * | K954697 | Ciba Corning Acs Estradiol-6 AssaySummary page 1…Clinical Chemistry F. Predicate Device: The ADVIA Centaur Calibrator 30 is substantially equivalent to the ADVIA Centaur Calibrator E which was cleared under K932715/K954697 G. Device Description: The ADVIA Centaur® Calibrator 30 is a 2 level human plasma based solutions containing varying concentrati… | 1995 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jun 7, 2017 | Class II | Z-0515-2018 | Under Investigation by firm | 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)… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- None of the 2 ancestors has a recall.
How does its category compare?
All JIT devicesJIT Calibrator, Secondary: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.
FDA decisions per year · JIT
7in 2017
2026 to Oct 25, outlined.
Median 510(k) review, days · JIT
28in 2017
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JIT
1in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JIT
7in 2025
MAUDE reports naming product code JIT, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 5 | 78 | 1 | 0 |
| 2008 | 6 | 46 | 0 | 0 |
| 2009 | 2 | — | 2 | 0 |
| 2010 | 6 | 65 | 0 | 3 |
| 2011 | 7 | 48 | 3 | 2 |
| 2012 | 2 | — | 3 | 10 |
| 2013 | 5 | 140 | 0 | 43 |
| 2014 | 10 | 33 | 2 | 9 |
| 2015 | 4 | 30 | 1 | 6 |
| 2016 | 4 | 33 | 0 | 3 |
| 2017 | 7 | 28 | 0 | 7 |
| 2018 | 0 | — | 5 | 8 |
| 2019 | 0 | — | 0 | 215 |
| 2020 | 0 | — | 2 | 12 |
| 2021 | 0 | — | 0 | 3 |
| 2022 | 0 | — | 0 | 4 |
| 2023 | 0 | — | 1 | 6 |
| 2024 | 0 | — | 0 | 17 |
| 2025 | 0 | — | 0 | 7 |
| 2026 | 0 | — | 1 | — |
What is it indicated for?
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K100293 · printed Nov 3, 2026
Cite this page
510(k) Report. “K100293: Advia Centaur Calibrator 30, Models 10379811/10379810.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K100293
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026