510(k) · Cleared
Recalled · Class II · 2017Vidas Testosterone (Tes), Model 30 418
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
bioMerieux, Inc. · CDZ Radioimmunoassay, Testosterones And Dihydrotestosterone
Cleared on Jul 18, 2002 as substantially equivalent to K813401 (Diagnostic Products Corp., 1981) and 1 other predicate after an 83-day review. Its family tree reaches back 1 generation to 1981. 1 later device descends from it. It has been recalled once.
- Decided
- Jul 18, 2002
- Review
- 83 days
- Class
- Class I
- Product code
- CDZ
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 1 generation to K813401 (1981). 2 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK813401 Coat-a-Count Testosterone Ria KitDiagnostic Products Corp. · 1981
- This deviceK021326 Vidas Testosterone (Tes), Model 30 418bioMerieux, Inc. · 2002
- Descendant · cites it directly · 0 of its ownK141133 VIDAS H. pylori IgG, VIDAS 3, VIDAS Lyme IgG II, VIDAS RUB IgG…Biomerieux · 2015 · Recalled
Most influential descendants
Showing 1 of 1 · See all- K141133VIDAS H. pylori IgG, VIDAS 3, VIDAS Lyme IgG II, VIDAS RUB IgG, VIDAS TOXO M, VIDAS…Biomerieux · 2015 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K813401 | Coat-a-Count Testosterone Ria Kit | Diagnostic Products Corp. | 1981 | — |
| 0 (this device) | K021326 | Vidas Testosterone (Tes), Model 30 418 | bioMerieux, Inc. | 2002 | — |
| +1 | K141133 | VIDAS H. pylori IgG, VIDAS 3, VIDAS Lyme IgG II, VIDAS RUB IgG, VIDAS TOXO M… | Biomerieux | 2015 | 4 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 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? (2)
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 |
|---|---|---|---|
| * | K813401 | Coat-a-Count Testosterone Ria KitSummary page 1…sterone, 2 1 CFR 5862.1680 Predicate Device Trade Name: Diagnostic Products Corporation Coat-A-Count@ Total Testosterone (K8 13401) CIBA Corning ACS Testosterone Immunoassay (K934562)… | 1981 |
| * | K934562 | Ciba Corning Acs Testosterone ImmunoassaySummary page 1…Total Testosterone (K8 13401) CIBA Corning ACS Testosterone Immunoassay (K934562) (CIBA now known as Chiron) Device Description: The VIDAS Testosterone (TES) Assay is an enzyme-linked fluorescent immunoassay… | 1993 |
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 |
|---|---|---|---|
| K141133 | VIDAS H. pylori IgG, VIDAS 3, VIDAS Lyme IgG II, VIDAS RUB IgG, VIDAS TOXO M, VIDAS… | 2015 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 15, 2017 | Class II | Z-2339-2017 | Under Investigation by firm | Complaints were received from customers observing falsely overestimate results or external quality control higher results than expected when performing tests with VIDAS Testosterone. |
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?
VDAS Testosterone is an automated test for use on the WAS analyzer for the enzyme immunoassay measure of total testosterone in human serum or plasma (heparin), using the ELFA technique (Enzyme Linked Fluorescent Assay). It is intended as an aid in the disgnosis and management of conditions involving excess or deficiency of this androgen.
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/K021326 · printed Nov 4, 2026
Cite this page
510(k) Report. “K021326: Vidas Testosterone (Tes), Model 30 418.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K021326
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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