510(k) · Cleared
ClearedTestosterone by Enzymeimmunoassay (Eia)
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 Feb 8, 2002 as substantially equivalent to K971823 (Diagnostic Systems Laboratories, Inc., 1997) after a 53-day review. Its family tree reaches back 1 generation to 1997.
- Decided
- Feb 8, 2002
- Review
- 53 days
- Class
- Class I
- Product code
- CDZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K971823 (1997). No later device cites it as a predicate yet.
- Root · 1 generation backK971823 Active Testosterone Eia (DSL-10-4000)Diagnostic Systems Laboratories, Inc. · 1997
- This deviceK014120 Testosterone by Enzymeimmunoassay (Eia)Diagnostics Biochem Canada, Inc. · 2002
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K971823 | Active Testosterone Eia (DSL-10-4000) | Diagnostic Systems Laboratories, Inc. | 1997 | — |
| 0 (this device) | K014120 | Testosterone by Enzymeimmunoassay (Eia) | Diagnostics Biochem Canada, Inc. | 2002 | — |
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 |
|---|---|---|---|
| * | K971823 | Active Testosterone Eia (DSL-10-4000)Summary page 1…im equivalence: Diagnostics System Laboratories,(DSL) 445 Medical Center Blvd. Webster, Texas, 77598 DSL 10-4000 Active™ Testosterone Enzymeimmunoassay (EiA) kit 510(K) #971823 7. The Testosterone (total) Elisa kit consists of one polyclonal antibody which is coated on microtiter plate (96… | 1997 |
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?
- Its one ancestor has no 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.
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-TE-250 EiAsy™ Testosterone enzymeimmunoassay (EiA) kit provides the reagents necessary for the direct determination of Testosterone in human serum The use of this assay is intended for in vitro diagnostic use only. Measurement of Testosterone are used in the diagnosis and treatment of disorders involving the male sex hormone (androgens), including primary and secondary hypogonadism, delayed or precocious puberty impotence in male and in females hirsutism (excessive hair) and virilization (masculinization) due to tumors, polycystic ovaries and adrenogenital syndromes.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K014120 · printed Nov 6, 2026
Cite this page
510(k) Report. “K014120: Testosterone by Enzymeimmunoassay (Eia).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K014120
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026