510(k) · Cleared
Recalled · Class II · 2026ST Aia-Pack Testosterone Assay
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Tosoh Medics, Inc. · CDZ Radioimmunoassay, Testosterones And Dihydrotestosterone
Cleared on Dec 17, 2002 as substantially equivalent to K831342 (Diagnostic Products Corp., 1983) after a 91-day review. Its family tree reaches back 1 generation to 1983. It has been recalled 3 times.
- Decided
- Dec 17, 2002
- Review
- 91 days
- Class
- Class I
- Product code
- CDZ
- Recalls
- 3
- 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 deviceK023091 ST Aia-Pack Testosterone AssayTosoh Medics, Inc. · 2002
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) | K023091 | ST Aia-Pack Testosterone Assay | Tosoh Medics, 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 |
|---|---|---|---|
| * | K831342 | Coat-a-Count NO-Extraction TestosteroneSummary page 1…ts Corporation Los Angeles, CA U.S.A. K831342 Device Description: The ST AIA-PACK Testosterone is a competitive immunoenzymometric assay which is… | 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jun 12, 2026 | Class II | Z-2746-2026 | Component design/selection | The Test cup lot F level 1 low-quality control results values for the device were lower than expected on the Automated Immunoassay Analyzer (AIA) which could cause falsely elevated or falsely low total testosterone results. Such erroneous… |
| Nov 30, 2018 | Class II | Z-0674-2019 | Device Design | |
| Mar 5, 2018 | Class II | Z-2093-2018 | Device Design | Asfotase Alfa (Strensiq) interferes with certain Tosoh assays which potentially causes falsely increased or falsely decreased immunoassay test results, depending upon the assay. |
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?
ST AIA-PACK Testosterone is intended for IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement of testosterone in human serum on specific TOSOH AIA System analyzers. Measurement of testosterone is used to aid in the diagnosis and management of conditions involving excess or deficiency of this androgen. This device is intended "For Professional Use" only. ST AIA-PACK Testosterone is intended for IN VITRO DIAGNOSTIC USE ONLY for the quantitative…
Read the full statement (110 words)
ST AIA-PACK Testosterone is intended for IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement of testosterone in human serum on specific TOSOH AIA System analyzers. Measurement of testosterone is used to aid in the diagnosis and management of conditions involving excess or deficiency of this androgen.
This device is intended "For Professional Use" only.
ST AIA-PACK Testosterone is intended for IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement of testosterone in human serum on specific TOSOH AIA System analyzers. Measurement of testosterone is used to aid in the diagnosis and management of conditions involving excess or deficiency of this androgen.
This device is intended "For Professional Use" only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K023091 · printed Nov 6, 2026
Cite this page
510(k) Report. “K023091: ST Aia-Pack Testosterone Assay.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K023091
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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