510(k) · Cleared
ClearedFree Testosterone AccuBind ELISA Test System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Monobind, Inc. · CDZ Radioimmunoassay, Testosterones And Dihydrotestosterone
Cleared on Jul 20, 2018 as substantially equivalent to K030730 (Diagnostics Biochem Canada, Inc., 2003) after a 101-day review. Its family tree reaches back 2 generations to 1985. 1 later device descends from it.
- Decided
- Jul 20, 2018
- Review
- 101 days
- Class
- Class I
- Product code
- CDZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K844423 (1985). 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK844423 Coat-a-Count Free Testosterone Kit & ComponentsDiagnostic Products Corp. · 1985
- 1 generation backK030730 Free Testosterone Enzymeimmunoassay (Eia) KitDiagnostics Biochem Canada, Inc. · 2003
- This deviceK181017 Free Testosterone AccuBind ELISA Test SystemMonobind, Inc. · 2018
- Descendant · cites it directly · 0 of its ownK240865 IDS-iSYS Free TestosteroneImmunodiagnostic Systems Limited · 2024
Most influential descendants
Showing 1 of 1 · See all- K240865IDS-iSYS Free TestosteroneImmunodiagnostic Systems Limited · 2024 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K844423 | Coat-a-Count Free Testosterone Kit & Components | Diagnostic Products Corp. | 1985 | — |
| −1 | K030730 | Free Testosterone Enzymeimmunoassay (Eia) Kit | Diagnostics Biochem Canada, Inc. | 2003 | — |
| 0 (this device) | K181017 | Free Testosterone AccuBind ELISA Test System | Monobind, Inc. | 2018 | — |
| +1 | K240865 | IDS-iSYS Free Testosterone | Immunodiagnostic Systems Limited | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 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 |
|---|---|---|---|
| * | K030730 | Free Testosterone Enzymeimmunoassay (Eia) KitSummary page 4…cal Chemistry 3. Predicate Device: EiAsy Free Testosterone EIA CompanyName: Diagnostic Biochem Canada, Inc. 510(k) Number: k030730 A. Test Principle: Monobind Inc. Free Testosterone test system uses a competitive enzyme immunoassay. The essential rea… | 2003 |
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 |
|---|---|---|---|
| K240865 | IDS-iSYS Free Testosterone | 2024 | 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 33 years and passes through 3 companies; a new generation was cleared every 18.5 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K240865 (Immunodiagnostic Systems Limited, 2024) has gone furthest, with 0 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. 2018, 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 Free Testosterone AccuBind® ELISA Test System is an Enzyme Immunoassay (EIA) for the quantitative measurement of free testosterone in human serum. 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 males and in females; hirsutism (excessive hair) and virilization (masculinization) due to tumors, polycystic ovaries and adrogenital syndromes.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K181017 · printed Nov 6, 2026
Cite this page
510(k) Report. “K181017: Free Testosterone AccuBind ELISA Test System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K181017
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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