510(k) · Cleared
ClearedElecsys Testosterone Assay
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Boehringer Mannheim Corp. · CDZ Radioimmunoassay, Testosterones And Dihydrotestosterone
Cleared on Mar 18, 1997 after a 102-day review. The summary cites one number, which could not be confirmed as its predicate (see the table below). 15 later devices descend from it.
- Decided
- Mar 18, 1997
- Review
- 102 days
- Class
- Class I
- Product code
- CDZ
- Recalls
- None
- Predicates
- 1
15 later devices descend from it, 3 citing it directly.
- This deviceK964889 Elecsys Testosterone AssayBoehringer Mannheim Corp. · 1997
- Descendant · cites it directly · 11 of its ownK093421 Elecsys Testosterone II ImmunoassayRoche Diagnostics Corp. · 2010
- Descendant · 2 generations on · 2 of its ownK151986 ADVA Centaur Testosterone II (TSTII), ADVA Centaur Testosterone II…Siemens Healthcare Diagnostics, Inc. · 2016
- Descendant · 2 generations on · 2 of its ownK120009 Testosterone Test System; Calibrator; and Quality Control Material…Abbott Laboratories · 2012
- Descendant · 2 generations on · 1 of its ownK211685 Elecsys Testosterone IIRoche Diagnostics · 2022
- Descendant · 2 generations on · 1 of its ownK122793 Liaison Testosterone; Liaison Testosterone Control SetDiaSorin, Inc. · 2013
Showing 5 of 15 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 15 · See all- K093421Elecsys Testosterone II ImmunoassayRoche Diagnostics Corp. · 2010 · cites it directly11descendants
- K151986ADVA Centaur Testosterone II (TSTII), ADVA Centaur Testosterone II (TSTII) Master Curve…Siemens Healthcare Diagnostics, Inc. · 2016 · 2 generations on2descendants
- K120009Testosterone Test System; Calibrator; and Quality Control Material (Assayed and Unassayed)Abbott Laboratories · 2012 · 2 generations on2descendants
- K211685Elecsys Testosterone IIRoche Diagnostics · 2022 · 2 generations on1descendant
- K122793Liaison Testosterone; Liaison Testosterone Control SetDiaSorin, Inc. · 2013 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K964889 | Elecsys Testosterone Assay | Boehringer Mannheim Corp. | 1997 | — |
| +1 | K093421 | Elecsys Testosterone II Immunoassay | Roche Diagnostics Corp. | 2010 | — |
| +2 | K151986 | ADVA Centaur Testosterone II (TSTII), ADVA Centaur Testosterone II (TSTII)… | Siemens Healthcare Diagnostics, Inc. | 2016 | — |
| +2 | K120009 | Testosterone Test System; Calibrator; and Quality Control Material (Assayed… | Abbott Laboratories | 2012 | — |
| +2 | K211685 | Elecsys Testosterone II | Roche Diagnostics | 2022 | — |
| +2 | K122793 | Liaison Testosterone; Liaison Testosterone Control Set | DiaSorin, Inc. | 2013 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2004 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 3 | 0 |
| 2019 | 2 | 0 |
| 2020 | 1 | 0 |
| 2022 | 1 | 0 |
| 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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| Kept off the family tree | K081349 | Coat-A-Count® Total Testosterone Assay Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree |
What descends from it? (15)
See all 153 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- Of its descendants, K093421 (Roche Diagnostics Corp., 2010) has gone furthest, with 11 descendants of its own.
How does its category compare?
All CDZ devicesCDZ Radioimmunoassay, Testosterones And Dihydrotestosterone: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 serum and plasma.
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/K964889 · printed Nov 6, 2026
Cite this page
510(k) Report. “K964889: Elecsys Testosterone Assay.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K964889
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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