510(k) · Cleared
ClearedBiodata Testosterone Maia Kit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biochem Immunosystems (U.S.), Inc. · CDZ Radioimmunoassay, Testosterones And Dihydrotestosterone
Cleared on Jun 24, 1996 as substantially equivalent to K831342 (Diagnostic Products Corp., 1983) after a 229-day review. Its family tree reaches back 1 generation to 1983.
- Decided
- Jun 24, 1996
- Review
- 229 days
- Class
- Class I
- Product code
- CDZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K831342 (1983). No later device cites it as a predicate yet.
- Root · 1 generation backK831342 Coat-a-Count NO-Extraction TestosteroneDiagnostic Products Corp. · 1983
- This deviceK955102 Biodata Testosterone Maia KitBiochem Immunosystems (U.S.), Inc. · 1996
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K831342 | Coat-a-Count NO-Extraction Testosterone | Diagnostic Products Corp. | 1983 | — |
| 0 (this device) | K955102 | Biodata Testosterone Maia Kit | Biochem Immunosystems (U.S.), Inc. | 1996 | — |
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 |
|---|---|---|---|
| * | K831342 | Coat-a-Count NO-Extraction TestosteroneSummary page 3…...... II. PREDICATE DEVICE The Biodata Testosterone Maia Kit is substantially equivalent to Diagnostic Products Corporation’s (“DPC”) Coat-A-Count Testosterone Assay (K831342). Biodata also manufactured this device without U.S. commercialization. I1I. PERFORMANCE DATA Substantial equivalence to the Se… | 1983 |
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.
- 1 other device also cites its predicate K831342.
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 Biodata Testosterone Maia Kit is a radioimmunoassay for the quantitative determination of testosterone in human serum or plasma. The device is intended to be used for the diagnosis of elevated or depressed levels of testosterone. It is FOR IN VITRO DIAGNOSTIC USE ONLY.
Neoplasms of the testes and adrenal cortex and hyperthyroidism may result in elevated levels of testosterone in the male. Elevated testosterone levels are observed in females with endometrial carcinoma, hirsutism, neoplasms of the ovaries, and Cushing syndrome. Patients with hypogonadism of pituitary origin, anorchia, gonadel dysgenesis, Klinefelter syndrome, and pseudohermaphroditism have decreased testosterone levels.
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/K955102 · printed Nov 4, 2026
Cite this page
510(k) Report. “K955102: Biodata Testosterone Maia Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K955102
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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