510(k) · Cleared

Cleared

Elecsys Testosterone II Immunoassay

K093421510(k) TraditionalCleared Apr 23, 2010171-day reviewClass I21 CFR 862.1680

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

Roche Diagnostics Corp. · CDZ Radioimmunoassay, Testosterones And Dihydrotestosterone

Cleared on Apr 23, 2010 as substantially equivalent to K964889 (Boehringer Mannheim Corp., 1997) after a 171-day review. Its family tree reaches back 1 generation to 1997. 11 later devices descend from it.

Decided: Apr 23, 2010
Review: 171 days
Class: Class I
Product code: CDZ
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K964889 (1997). 11 later devices descend from it, 5 citing it directly.

By dateBy generation

Root · 1 generation backK964889 Elecsys Testosterone AssayBoehringer Mannheim Corp. · 1997
This deviceK093421 Elecsys Testosterone II ImmunoassayRoche Diagnostics Corp. · 2010
Descendant · cites it directly · 2 of its ownK151986 ADVA Centaur Testosterone II (TSTII), ADVA Centaur Testosterone II…Siemens Healthcare Diagnostics, Inc. · 2016
Descendant · cites it directly · 2 of its ownK120009 Testosterone Test System; Calibrator; and Quality Control Material…Abbott Laboratories · 2012
Descendant · cites it directly · 1 of its ownK211685 Elecsys Testosterone IIRoche Diagnostics · 2022
Descendant · cites it directly · 1 of its ownK122793 Liaison Testosterone; Liaison Testosterone Control SetDiaSorin, Inc. · 2013
Descendant · 2 generations on · 0 of its ownK252728 IDS-iSYS Total TestosteroneImmunodiagnostic Systems Limited · 2026

Showing 5 of 11 descendants. See all descendants

Descendants cleared per year

2012high 3 (2016) · low 0 (2014)2026

Most influential descendants

Showing 5 of 11 · See all

K151986ADVA Centaur Testosterone II (TSTII), ADVA Centaur Testosterone II (TSTII) Master Curve…Siemens Healthcare Diagnostics, Inc. · 2016 · cites it directly2descendants
K120009Testosterone Test System; Calibrator; and Quality Control Material (Assayed and Unassayed)Abbott Laboratories · 2012 · cites it directly2descendants
K211685Elecsys Testosterone IIRoche Diagnostics · 2022 · cites it directly1descendant
K122793Liaison Testosterone; Liaison Testosterone Control SetDiaSorin, Inc. · 2013 · cites it directly1descendant
K252728IDS-iSYS Total TestosteroneImmunodiagnostic Systems Limited · 2026 · 2 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K964889	Elecsys Testosterone Assay	Boehringer Mannheim Corp.	1997	—
0 (this device)	K093421	Elecsys Testosterone II Immunoassay	Roche Diagnostics Corp.	2010	—
+1	K151986	ADVA Centaur Testosterone II (TSTII), ADVA Centaur Testosterone II (TSTII)…	Siemens Healthcare Diagnostics, Inc.	2016	—
+1	K120009	Testosterone Test System; Calibrator; and Quality Control Material (Assayed…	Abbott Laboratories	2012	—
+1	K211685	Elecsys Testosterone II	Roche Diagnostics	2022	—
+1	K122793	Liaison Testosterone; Liaison Testosterone Control Set	DiaSorin, Inc.	2013	—
+2	K252728	IDS-iSYS Total Testosterone	Immunodiagnostic Systems Limited	2026	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2012	1	0
2013	1	0
2015	1	0
2016	3	0
2019	2	0
2020	1	0
2022	1	0
2026	1	0

FIG. 1 — Lineage of K093421, 1997–2026Source: 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 CDZ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new CDZ device

#1 K252728 IDS-iSYS Total Testosteronescore 11.8 · 3 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin 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
*	K964889	Elecsys Testosterone Assay Summary page 1 …lent to other Equivalence devices legally marketed in the United States. We claim equivalency to the currently marketed Elecsys Testosterone Assay (K964889). Continued on next page…	Boehringer Mannheim Corp.	1997	—

Also cleared against K964889: 2 other devices →

What descends from it? (11)

See all 11

5 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K151986	ADVA Centaur Testosterone II (TSTII), ADVA Centaur Testosterone II (TSTII) Master Curve…	Siemens Healthcare Diagnostics, Inc.	2016	2
K120009	Testosterone Test System; Calibrator; and Quality Control Material (Assayed and Unassayed)	Abbott Laboratories	2012	2
K211685	Elecsys Testosterone II	Roche Diagnostics	2022	1
K122793	Liaison Testosterone; Liaison Testosterone Control Set	DiaSorin, Inc.	2013	1
K151529	Dimension Vista LOCI Total Testosterone Flex reagent cartridge, Dimension Vista…	Siemens Healthcare Diagnostics, Inc.	2016	0

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?

Its one ancestor has no recall.
Of its descendants, K151986 (Siemens Healthcare Diagnostics, Inc., 2016) has gone furthest, with 2 descendants of its own.
2 other devices also cite its predicate K964889.

How does its category compare?

All CDZ devices

CDZ Radioimmunoassay, Testosterones And Dihydrotestosterone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.

FDA decisions per year · CDZ

2in 2024

2007high 4 (2016) · low 0 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · CDZ

141in 2019

2007high 276 (2016) · low 141 (2019)2026

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

Recalls per year · CDZ

1in 2025

2007high 1 (2010) · low 0 (2007)2026

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

Adverse event reports per year · CDZ

17in 2025

2007high 19 (2011) · low 1 (2009)2025

MAUDE reports naming product code CDZ, 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	1	—	0	6
2008	0	—	0	3
2009	1	—	0	1
2010	2	—	1	1
2011	2	—	0	19
2012	1	—	0	9
2013	1	—	1	7
2014	1	—	0	10
2015	2	—	0	7
2016	4	276	0	5
2017	0	—	0	12
2018	1	—	1	5
2019	4	141	0	3
2020	1	—	0	12
2021	0	—	0	7
2022	1	—	1	3
2023	1	—	0	10
2024	2	—	1	11
2025	0	—	1	17
2026	1	—	1	—

What is it indicated for?

Immunoassay for the in vitro quantitative determination of testosterone in human serum and plasma. The electrochemiluminescence immunoassay "ECLIA" is intended for use on Elecsys and cobas e immunoassay analyzers.

Measurements of testosterone are used in the diagnosis and treatment of disorders involving the male sex hormones (androgens), including primary and secondary hypogonadism, delayed or precocious puberty, impotence in males and, in females hirsutism (excessive hair) and virilization (masculinization) due to tumors, polycystic ovaries, and androgenital syndromes.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K093421 · printed Nov 6, 2026

Cite this page

510(k) Report. “K093421: Elecsys Testosterone II Immunoassay.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K093421

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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