510(k) · Cleared
ClearedFree Testosterone Enzymeimmunoassay (Eia) Kit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Diagnostics Biochem Canada, Inc. · CDZ Radioimmunoassay, Testosterones And Dihydrotestosterone
Cleared on Aug 18, 2003 as substantially equivalent to K844423 (Diagnostic Products Corp., 1985) after a 161-day review. Its family tree reaches back 1 generation to 1985. 2 later devices descend from it.
- Decided
- Aug 18, 2003
- Review
- 161 days
- Class
- Class I
- Product code
- CDZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K844423 (1985). 2 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK844423 Coat-a-Count Free Testosterone Kit & ComponentsDiagnostic Products Corp. · 1985
- This deviceK030730 Free Testosterone Enzymeimmunoassay (Eia) KitDiagnostics Biochem Canada, Inc. · 2003
- Descendant · cites it directly · 1 of its ownK181017 Free Testosterone AccuBind ELISA Test SystemMonobind, Inc. · 2018
- Descendant · 2 generations on · 0 of its ownK240865 IDS-iSYS Free TestosteroneImmunodiagnostic Systems Limited · 2024
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K844423 | Coat-a-Count Free Testosterone Kit & Components | Diagnostic Products Corp. | 1985 | — |
| 0 (this device) | K030730 | Free Testosterone Enzymeimmunoassay (Eia) Kit | Diagnostics Biochem Canada, Inc. | 2003 | — |
| +1 | K181017 | Free Testosterone AccuBind ELISA Test System | Monobind, Inc. | 2018 | — |
| +2 | K240865 | IDS-iSYS Free Testosterone | Immunodiagnostic Systems Limited | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 1 | 0 |
| 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 |
|---|---|---|---|
| * | K844423 | Coat-a-Count Free Testosterone Kit & ComponentsSummary page 1…Angeles, CA, 900159597 COAT-A-Count' Rea Testosterone kit Cat. No. TKTFl(l(b0 tubes) and TKFTZ (200tubes) 5 1O(K) K844423 7. The free Testosterone Elisa kit cpnsists o f one polyclonal antibody which is coated on microtiter plate (96 wells per kit)… | 1985 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K181017 | Free Testosterone AccuBind ELISA Test System | 2018 | 1 |
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?
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?
The dbc CAN-fTE-260 EiAsyTMFree Testosterone enzymeimmunoassay (EiA) kit
provides the reagents necessary for the direct determination of Free Testosterone in
human serum. This assay is intended for in vitro diagnostic use only. Measurement of
Free Testosterone are used in the diagnosis in male sex hormones (androgens) and in
females hrsutism (excessive hair) and virilisation (masculinization).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K030730 · printed Nov 4, 2026
Cite this page
510(k) Report. “K030730: Free Testosterone Enzymeimmunoassay (Eia) Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K030730
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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