510(k) · Cleared

Cleared

Advia Centaur Dheas Master Curve Materials

K091123510(k) AbbreviatedCleared Aug 14, 2009119-day reviewClass I21 CFR 862.1660

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Siemens Healthcare Diagnostics · JJX Single (Specified) Analyte Controls (Assayed And Unassayed)

Cleared on Aug 14, 2009 as substantially equivalent to K062501 (Maine Standards Co., 2006) after a 119-day review. Its family tree reaches back 3 generations to 1995.

Decided: Aug 14, 2009
Review: 119 days
Class: Class I
Product code: JJX
Recalls: None
Predicates: 1

Its longest line of descent runs back 3 generations to K950469 (1995). No later device cites it as a predicate yet.

By dateBy generation

Root · 3 generations backK950469 Document Serum Multianalyte Calibration Verification Test SetCasco Standards · 1995
2 generations backK992034 Document Thyroid Cal*VerCasco-Nerl Diagnostics Corporation (Maine) · 1999
1 generation backK062501 Validate Thyroid Calibration Verification / Linearity Test Set…Maine Standards Co. · 2006
This deviceK091123 Advia Centaur Dheas Master Curve MaterialsSiemens Healthcare Diagnostics · 2009

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−3	K950469	Document Serum Multianalyte Calibration Verification Test Set	Casco Standards	1995	—
−2	K992034	Document Thyroid Cal*Ver	Casco-Nerl Diagnostics Corporation (Maine)	1999	—
−1	K062501	Validate Thyroid Calibration Verification / Linearity Test Set, Model 901	Maine Standards Co.	2006	—
0 (this device)	K091123	Advia Centaur Dheas Master Curve Materials	Siemens Healthcare Diagnostics	2009	—

FIG. 1 — Lineage of K091123, 1995–2009Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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 JJX? 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

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What was it cleared against? (1)

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	Applicant	Decided	Recalls
*	K062501	Validate Thyroid Calibration Verification / Linearity Test Set, Model 901 Summary page 1 …e Name VALIDATE Thyroid Calibration Verification Test Set Common name VALIDATE THY Calibration Verification Test Set 510(k) Number K062501 Manufacturer Maine Standards Company Siemens Healthcare Diagnostics ADVIA Centaur DHEAS Master Curve Materials P…	Maine Standards Co.	2006	—

Also cleared against K062501: 4 other devices →

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

The line of descent spans 14 years and passes through 4 companies; a new generation was cleared every 4.3 years on median.
None of the 3 ancestors has a recall.
4 other devices also cite its predicate K062501.

How does its category compare?

All JJX devices

JJX Single (Specified) Analyte Controls (Assayed And Unassayed): FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.

FDA decisions per year · JJX

2in 2017

2007high 24 (2010) · low 0 (2018)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · JJX

31in 2016

2007high 80 (2009) · low 30 (2014)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · JJX

1in 2021

2007high 3 (2007) · low 0 (2009)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · JJX

22in 2025

2007high 82 (2019) · low 0 (2008)2025

MAUDE reports naming product code JJX, 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	6	53	3	2
2008	8	52	3	0
2009	17	80	0	1
2010	24	80	3	6
2011	19	62	2	62
2012	15	40	0	32
2013	19	37	0	51
2014	22	30	1	48
2015	11	65	1	67
2016	6	31	2	37
2017	2	—	0	19
2018	0	—	2	35
2019	0	—	0	82
2020	0	—	0	77
2021	0	—	1	43
2022	0	—	0	24
2023	0	—	0	22
2024	0	—	0	30
2025	0	—	0	22
2026	0	—	0	—

What is it indicated for?

The ADVIA® Centaur (DHEAS) Master Curve Material are for in vitro diagnostic use in the verification of calibration and reportable range in the ADVIA Centaur® Systems Dehydroepiandrosterone sulfate (DHEAS) assay.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K091123 · printed Nov 6, 2026

Cite this page

510(k) Report. “K091123: Advia Centaur Dheas Master Curve Materials.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K091123

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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