510(k) · Cleared
ClearedLiaison Testosterone; Liaison Testosterone Control Set
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
DiaSorin, Inc. · CDZ Radioimmunoassay, Testosterones And Dihydrotestosterone
Cleared on Jan 25, 2013 as substantially equivalent to K093421 (Roche Diagnostics Corp., 2010) after a 135-day review. Its family tree reaches back 2 generations to 1997. 1 later device descends from it.
- Decided
- Jan 25, 2013
- Review
- 135 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 deviceK122793 Liaison Testosterone; Liaison Testosterone Control SetDiaSorin, Inc. · 2013
- Descendant · cites it directly · 0 of its ownK201908 LIAISON Testosterone xtDiaSorin, Inc. · 2020
Most influential descendants
Showing 1 of 1 · See all- K201908LIAISON Testosterone xtDiaSorin, Inc. · 2020 · 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) | K122793 | Liaison Testosterone; Liaison Testosterone Control Set | DiaSorin, Inc. | 2013 | — |
| +1 | K201908 | LIAISON Testosterone xt | DiaSorin, Inc. | 2020 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 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.
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 |
|---|---|---|---|
| K201908 | LIAISON Testosterone xt | 2020 | 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 16 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, K201908 (DiaSorin, Inc., 2020) 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. 2013, 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?
The DiaSorin LIAISON® Testosterone assay is a direct, competitive, chemiluminescence immunoassay (CLIA) intended for the quantitative determination of testosterone in human serum and plasma on the LIAISON®Analyzer. The assay is intended for in vitro diagnostic use. Measurement of testosterone is used in the diagnosis and treatment of disorders involving the male sex hormones (androgens), including primary and secondary hypogonadism, delayed or precocious…
Read the full statement (112 words)
The DiaSorin LIAISON® Testosterone assay is a direct, competitive, chemiluminescence immunoassay (CLIA) intended for the quantitative determination of testosterone in human serum and plasma on the LIAISON®Analyzer. The assay is intended for in vitro diagnostic use.
Measurement of testosterone is 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 male subjects and, in female subjects hirsutism (excessive hair) and virilization (naasculinization) due to tumors, polycystic ovaries, and adrendgenital syndromes.
The DiaSorin LIAISON® Testosterone Control Set is intended for use as assayed quality control samples to monitor the accuracy and precision of the DiaSorin LIAISON® Testosterone immunoassay.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K122793 · printed Nov 6, 2026
Cite this page
510(k) Report. “K122793: Liaison Testosterone; Liaison Testosterone Control Set.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K122793
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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