510(k) · Cleared
ClearedIDS-iSYS Total Testosterone
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Immunodiagnostic Systems Limited · CDZ Radioimmunoassay, Testosterones And Dihydrotestosterone
Cleared on Apr 15, 2026 as substantially equivalent to K211685 (Roche Diagnostics, 2022) after a 230-day review. Its family tree reaches back 3 generations to 1997.
- Decided
- Apr 15, 2026
- Review
- 230 days
- Class
- Class I
- Product code
- CDZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K964889 (1997). No later device cites it as a predicate yet.
- Root · 3 generations backK964889 Elecsys Testosterone AssayBoehringer Mannheim Corp. · 1997
- 2 generations backK093421 Elecsys Testosterone II ImmunoassayRoche Diagnostics Corp. · 2010
- 1 generation backK211685 Elecsys Testosterone IIRoche Diagnostics · 2022
- This deviceK252728 IDS-iSYS Total TestosteroneImmunodiagnostic Systems Limited · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K964889 | Elecsys Testosterone Assay | Boehringer Mannheim Corp. | 1997 | — |
| −2 | K093421 | Elecsys Testosterone II Immunoassay | Roche Diagnostics Corp. | 2010 | — |
| −1 | K211685 | Elecsys Testosterone II | Roche Diagnostics | 2022 | — |
| 0 (this device) | K252728 | IDS-iSYS Total Testosterone | Immunodiagnostic Systems Limited | 2026 | — |
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 K240865 IDS-iSYS Free Testosteronescore 8.8 · 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 |
|---|---|---|---|
| * | K211685 | Elecsys Testosterone IISummary page 6…Product Code: CDZ Revvity Proprietary Information Predicate Device Elecsys Testosterone II (k211685) Device Description The IDS-iSYS Total Testosterone assay consists of a reagent cartridge. The reagent cartrid… | 2022 |
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 29 years and passes through 4 companies; a new generation was cleared every 12.0 years on median.
- None of the 3 ancestors has a recall.
How does its category compare?
All CDZ devicesCDZ Radioimmunoassay, Testosterones And Dihydrotestosterone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, 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 IDS-iSYS Total Testosterone assay is an in vitro diagnostic device intended for the quantitative determination of testosterone in human serum or plasma on the IDS system.
Measurement 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/K252728 · printed Nov 5, 2026
Cite this page
510(k) Report. “K252728: IDS-iSYS Total Testosterone.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K252728
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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