510(k) · Cleared
ClearedAbbott Axsym Testosterone Microparticle Enzyme Immunoassay (Meia)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Axis-Shield Diagnostics, Ltd. · CDZ Radioimmunoassay, Testosterones And Dihydrotestosterone
Cleared on Sep 29, 2004 as substantially equivalent to K964889 (Boehringer Mannheim Corp., 1997) after an 82-day review. Its family tree reaches back 1 generation to 1997.
- Decided
- Sep 29, 2004
- Review
- 82 days
- Class
- Class I
- Product code
- CDZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K964889 (1997). No later device cites it as a predicate yet.
- Root · 1 generation backK964889 Elecsys Testosterone AssayBoehringer Mannheim Corp. · 1997
- This deviceK041866 Abbott Axsym Testosterone Microparticle Enzyme Immunoassay (Meia)Axis-Shield Diagnostics, Ltd. · 2004
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K964889 | Elecsys Testosterone Assay | Boehringer Mannheim Corp. | 1997 | — |
| 0 (this device) | K041866 | Abbott Axsym Testosterone Microparticle Enzyme Immunoassay (Meia) | Axis-Shield Diagnostics, Ltd. | 2004 | — |
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 |
|---|---|---|---|
| * | K964889 | Elecsys Testosterone AssaySummary page 1…or the determination of Testosterone. Classification name: Testosterone test system Predicate Device Substantial equivalence to the Roche Elecsys® Testosterone assay (K964889) is claimed. Axis-Shield Diagnostics Ltd ko1 i' - AxSYM®Testosterone 7 th July… | 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.
- 2 other devices also cite its predicate K964889.
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?
AxSYM® Testosterone is a Microparticle Enzyme Ihmunoassay (MEIA) for the quantitative determination of testosterone in human serum and plasma on the AxSYM System. Testosterone monitoring is used clinically to diagnose and differentiate endocrine disorders. In males, these include hypogonadism, testicular failure, infertility, hypopituitarism and hyperprolactinemia. In females, polycystic ovary syndrome, adrenal hyperplasia, infertility, hirsutism…
Read the full statement (115 words)
AxSYM® Testosterone is a Microparticle Enzyme Ihmunoassay (MEIA) for the quantitative determination of testosterone in human serum and plasma on the AxSYM System.
Testosterone monitoring is used clinically to diagnose and differentiate endocrine disorders. In males, these include hypogonadism, testicular failure, infertility, hypopituitarism and hyperprolactinemia. In females, polycystic ovary syndrome, adrenal hyperplasia, infertility, hirsutism, amenorrhea, obesity and virilization can cause changes in serum testosterone levels. The AxSYM® Testosterone assay is used as an aid in the investigation of infertility in males and of hirsutism and virilization in females.
The AxSYM® Testosterone Standard Calibrators are for the standard calibration of the AxSYM system when used for the quantitative determination of testosterone in human serum and plasma.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K041866 · printed Nov 6, 2026
Cite this page
510(k) Report. “K041866: Abbott Axsym Testosterone Microparticle Enzyme Immunoassay (Meia).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K041866
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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