510(k) · Cleared
ClearedElecsys Testosterone II
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Roche Diagnostics · CDZ Radioimmunoassay, Testosterones And Dihydrotestosterone
Cleared on May 6, 2022 as substantially equivalent to K093421 (Roche Diagnostics Corp., 2010) after a 338-day review. Its family tree reaches back 2 generations to 1997. 1 later device descends from it.
- Decided
- May 6, 2022
- Review
- 338 days
- Class
- Class I
- Product code
- CDZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K964889 (1997). 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK964889 Elecsys Testosterone AssayBoehringer Mannheim Corp. · 1997
- 1 generation backK093421 Elecsys Testosterone II ImmunoassayRoche Diagnostics Corp. · 2010
- This deviceK211685 Elecsys Testosterone IIRoche Diagnostics · 2022
- Descendant · cites it directly · 0 of its ownK252728 IDS-iSYS Total TestosteroneImmunodiagnostic Systems Limited · 2026
Most influential descendants
Showing 1 of 1 · See all- K252728IDS-iSYS Total TestosteroneImmunodiagnostic Systems Limited · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K964889 | Elecsys Testosterone Assay | Boehringer Mannheim Corp. | 1997 | — |
| −1 | K093421 | Elecsys Testosterone II Immunoassay | Roche Diagnostics Corp. | 2010 | — |
| 0 (this device) | K211685 | Elecsys Testosterone II | Roche Diagnostics | 2022 | — |
| +1 | K252728 | IDS-iSYS Total Testosterone | Immunodiagnostic Systems Limited | 2026 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2026 | 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 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
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 | Decided |
|---|---|---|---|
| * | K093421 | Elecsys Testosterone II ImmunoassaySummary page 4…Testosterones And Dihydrotestosterone Product Codes, CDZ Regulation Numbers 21 CFR 862.1680 Predicate Devices Elecsys Testosterone II (K093421) Roche Diagnostics GmbH Mannheim, Germany: 9610126 Establishment Registration Roche Diagnostics Gm… | 2010 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K252728 | IDS-iSYS Total Testosterone | 2026 | 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?
- The line of descent spans 25 years and passes through 3 companies; a new generation was cleared every 13.1 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K252728 (Immunodiagnostic Systems Limited, 2026) has gone furthest, with 0 descendants of its own.
- 4 other devices also cite its predicate K093421.
How does its category compare?
All CDZ devicesCDZ Radioimmunoassay, Testosterones And Dihydrotestosterone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, this device’s year, is highlighted.
FDA decisions per year · CDZ
2in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · CDZ
141in 2019
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · CDZ
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · CDZ
17in 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 the cobas e 601 immunoassay analyzer.
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 adrenogenital syndromes.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K211685 · printed Nov 6, 2026
Cite this page
510(k) Report. “K211685: Elecsys Testosterone II.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K211685
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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