510(k) · Cleared

Cleared

ADIVA Centaur Prolactin Master Curve Material (MCM), ADIVA Centaur Cortisol Master Curve Material (MCM)

K143194510(k) TraditionalCleared Dec 5, 201429-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, Inc. · JJX Single (Specified) Analyte Controls (Assayed And Unassayed)

Cleared on Dec 5, 2014 as substantially equivalent to K110613 (Roche Diagnostics, 2011) and 1 other predicate after a 29-day review. Its family tree reaches back 7 generations to 2000.

Decided: Dec 5, 2014
Review: 29 days
Class: Class I
Product code: JJX
Recalls: None
Predicates: 2

Its longest line of descent runs back 7 generations to K001015 (2000). 8 ancestors in all, the oldest K000576 (2000). No later device cites it as a predicate yet.

By dateBy generation

Root · 7 generations backK001015 Elecsys Thyroglobulin CalcheckRoche Diagnostics Corp. · 2000
6 generations backK020883 Elecsys Probnp CalcheckRoche Diagnostics Corp. · 2002
5 generations backK031698 Elecys SHBG CalcheckRoche Diagnostics Corp. · 2003
4 generations backK040157 Elecsys C-Peptide CalcheckRoche Diagnostics Corp. · 2004
3 generations backK100810 Elecsys C-Peptide Calcheck 5Roche Diagnostics · 2010
2 generations backK103402 Elecsys Dhea-S Calcheck 5Roche Diagnostics · 2011
1 generation backK110613 Elecsys Prolactin II Calcheck 5Roche Diagnostics · 2011
This deviceK143194 ADIVA Centaur Prolactin Master Curve Material (MCM), ADIVA Centaur…Siemens Healthcare Diagnostics, Inc. · 2014

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−7	K001015	Elecsys Thyroglobulin Calcheck	Roche Diagnostics Corp.	2000	—
−6	K020883	Elecsys Probnp Calcheck	Roche Diagnostics Corp.	2002	—
−5	K031698	Elecys SHBG Calcheck	Roche Diagnostics Corp.	2003	—
−4	K040157	Elecsys C-Peptide Calcheck	Roche Diagnostics Corp.	2004	—
−3	K100810	Elecsys C-Peptide Calcheck 5	Roche Diagnostics	2010	—
−2	K103402	Elecsys Dhea-S Calcheck 5	Roche Diagnostics	2011	—
−1	K110613	Elecsys Prolactin II Calcheck 5	Roche Diagnostics	2011	—
0 (this device)	K143194	ADIVA Centaur Prolactin Master Curve Material (MCM), ADIVA Centaur Cortisol…	Siemens Healthcare Diagnostics, Inc.	2014	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
2000	1	0

FIG. 1 — Lineage of K143194, 2000–2014Source: 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

Get a 510(k) 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	Applicant	Decided	Recalls
*	K110613	Elecsys Prolactin II Calcheck 5 Summary page 5 …yed) Panel: Clinical Chemistry (75) 3. Predicate Device Name Elecsys Prolactin II CalCheck 5 Predicate 510(k) No: K110613 4. Device Description: ADVIA Centaur® Prolactin Master Curve Material is an in…	Roche Diagnostics	2011	—
*	K000576	Elecsys Cortisol Calcheck Summary page 12 …Panel: Clinical Chemistry (75) 3. Predicate Device Name Elecsys Cortisol CalCheck Predicate 510(k) No: K000576 4. Device Description: ADVIA Centaur® Cortisol Master Curve Materials is an in vitro…	Roche Diagnostics Corp.	2000	—

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 3 companies; a new generation was cleared every 9 months on median.
None of the 8 ancestors has a recall.

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. 2014, 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® Prolactin (PRL) Master Curve Material is for in vitro diagnostic use in the verification of calibration and reportable range of the ADVIA Centaur Prolactin assay.

The ADVIA Centaur® Cortisol (COR) Master Curve Material is for in vitro diagnostic use in the verification of calibration and reportable range of the ADVIA Centaur Cortisol assay.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K143194 · printed Nov 5, 2026

Cite this page

510(k) Report. “K143194: ADIVA Centaur Prolactin Master Curve Material (MCM), ADIVA Centaur Cortisol Master Curve Material (MCM).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K143194

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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