510(k) · Cleared
ClearedIDS-iSYS Free 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 Oct 23, 2024 as substantially equivalent to K181017 (Monobind, Inc., 2018) after a 209-day review. Its family tree reaches back 3 generations to 1985.
- Decided
- Oct 23, 2024
- Review
- 209 days
- Class
- Class I
- Product code
- CDZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K844423 (1985). No later device cites it as a predicate yet.
- Root · 3 generations backK844423 Coat-a-Count Free Testosterone Kit & ComponentsDiagnostic Products Corp. · 1985
- 2 generations backK030730 Free Testosterone Enzymeimmunoassay (Eia) KitDiagnostics Biochem Canada, Inc. · 2003
- 1 generation backK181017 Free Testosterone AccuBind ELISA Test SystemMonobind, Inc. · 2018
- This deviceK240865 IDS-iSYS Free TestosteroneImmunodiagnostic Systems Limited · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K844423 | Coat-a-Count Free Testosterone Kit & Components | Diagnostic Products Corp. | 1985 | — |
| −2 | K030730 | Free Testosterone Enzymeimmunoassay (Eia) Kit | Diagnostics Biochem Canada, Inc. | 2003 | — |
| −1 | K181017 | Free Testosterone AccuBind ELISA Test System | Monobind, Inc. | 2018 | — |
| 0 (this device) | K240865 | IDS-iSYS Free Testosterone | Immunodiagnostic Systems Limited | 2024 | — |
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 |
|---|---|---|---|
| * | K181017 | Free Testosterone AccuBind ELISA Test SystemSummary page 6…Class 1 reserved Product Code: CDZ K240865 Predicate Device Free Testosterone AccuBind® ELISA Test System (k181017) Device Description The IDS-iSYS Free Testosterone assay consists of a reagent cartridge. The reagent cartridg… | 2018 |
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 39 years and passes through 4 companies; a new generation was cleared every 14.9 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. 2024, 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 Free Testosterone assay is an in vitro diagnostic device intended for the quantitative determination of free testosterone in human serum or plasma on the IDS system. Measurement of free testosterone is used in the diagnosis and treatment of disorders involving the male sex hormones (androgens), including primary and secondary hypogonadism, impotence in male 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/K240865 · printed Nov 4, 2026
Cite this page
510(k) Report. “K240865: IDS-iSYS Free Testosterone.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K240865
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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