510(k) · Cleared
ClearedCoat-a-Count Free Testosterone Kit & Components
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Diagnostic Products Corp. · CDZ Radioimmunoassay, Testosterones And Dihydrotestosterone
Cleared on Feb 27, 1985 after a 104-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 4 later devices descend from it.
- Decided
- Feb 27, 1985
- Review
- 104 days
- Class
- Class I
- Product code
- CDZ
- Recalls
- None
- Predicates
- 0
4 later devices descend from it, 2 citing it directly.
- This deviceK844423 Coat-a-Count Free Testosterone Kit & ComponentsDiagnostic Products Corp. · 1985
- Descendant · cites it directly · 2 of its ownK030730 Free Testosterone Enzymeimmunoassay (Eia) KitDiagnostics Biochem Canada, Inc. · 2003
- Descendant · 2 generations on · 1 of its ownK181017 Free Testosterone AccuBind ELISA Test SystemMonobind, Inc. · 2018
- Descendant · 3 generations on · 0 of its ownK240865 IDS-iSYS Free TestosteroneImmunodiagnostic Systems Limited · 2024
- Descendant · cites it directly · 0 of its ownK022533 Fastpack Testosterone CalibratorQualigen, Inc. · 2002
Most influential descendants
Showing 4 of 4 · See all- K030730Free Testosterone Enzymeimmunoassay (Eia) KitDiagnostics Biochem Canada, Inc. · 2003 · cites it directly2descendants
- K181017Free Testosterone AccuBind ELISA Test SystemMonobind, Inc. · 2018 · 2 generations on1descendant
- K240865IDS-iSYS Free TestosteroneImmunodiagnostic Systems Limited · 2024 · 3 generations on0descendants
- K022533Fastpack Testosterone CalibratorQualigen, Inc. · 2002 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K844423 | Coat-a-Count Free Testosterone Kit & Components | Diagnostic Products Corp. | 1985 | — |
| +1 | K030730 | Free Testosterone Enzymeimmunoassay (Eia) Kit | Diagnostics Biochem Canada, Inc. | 2003 | — |
| +2 | K181017 | Free Testosterone AccuBind ELISA Test System | Monobind, Inc. | 2018 | — |
| +3 | K240865 | IDS-iSYS Free Testosterone | Immunodiagnostic Systems Limited | 2024 | — |
| +1 | K022533 | Fastpack Testosterone Calibrator | Qualigen, Inc. | 2002 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2018 | 1 | 0 |
| 2024 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (4)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- Of its descendants, K030730 (Diagnostics Biochem Canada, Inc., 2003) has gone furthest, with 2 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.
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 | — |
https://510kreport.com/device/K844423 · printed Nov 6, 2026
Cite this page
510(k) Report. “K844423: Coat-a-Count Free Testosterone Kit & Components.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K844423
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026