510(k) · Cleared
Recalled · Class II · 2018ST AIA-PACK SHBG, ST AIA-PACK SHBG Calibrator Set
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Tosoh Bioscience, Inc. · CDZ Radioimmunoassay, Testosterones And Dihydrotestosterone
Cleared on Jul 2, 2015 as substantially equivalent to K060818 (Biokit, S.A., 2007) after a 248-day review. Its family tree reaches back 3 generations to 1994. It has been recalled once.
- Decided
- Jul 2, 2015
- Review
- 248 days
- Class
- Class I
- Product code
- CDZ
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 3 generations to K941797 (1994). No later device cites it as a predicate yet.
- Root · 3 generations backK941797 Immulite SHBGDiagnostic Products Corp. · 1994
- 2 generations backK031717 Elecsys SHBG ImmunoassayRoche Diagnostics Corp. · 2003
- 1 generation backK060818 Architect SHBG Reagent Kit, Architect SHBG Calibrator Kit, and…Biokit, S.A. · 2007 · Recalled
- This deviceK143075 ST AIA-PACK SHBG, ST AIA-PACK SHBG Calibrator SetTosoh Bioscience, Inc. · 2015
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K941797 | Immulite SHBG | Diagnostic Products Corp. | 1994 | — |
| −2 | K031717 | Elecsys SHBG Immunoassay | Roche Diagnostics Corp. | 2003 | — |
| −1 | K060818 | Architect SHBG Reagent Kit, Architect SHBG Calibrator Kit, and Architect SHBG… | Biokit, S.A. | 2007 | 1 |
| 0 (this device) | K143075 | ST AIA-PACK SHBG, ST AIA-PACK SHBG Calibrator Set | Tosoh Bioscience, Inc. | 2015 | — |
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 |
|---|---|---|---|
| * | K060818 | Architect SHBG Reagent Kit, Architect SHBG Calibrator Kit, and Architect SHBG Control…Summary page 5…Class II JIT Clinical Chemistry 21 CFR 862.1150 Predicate Device: k060818 Abbott/ BIOKIT S.A. ARCHITECT SHBG REAGENT KIT, ARCHITECT… | 2007 |
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 |
|---|---|---|---|---|
| Mar 5, 2018 | Class II | Z-2092-2018 | 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?
- The line of descent spans 21 years and passes through 4 companies; a new generation was cleared every 8.4 years on median.
- 1 of the 3 ancestors has a recall of any class.
- 1 other device also cites its predicate K060818.
How does its category compare?
All CDZ devicesCDZ Radioimmunoassay, Testosterones And Dihydrotestosterone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, this device’s year, is highlighted.
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 SHBG is designed for In Vitro Diagnostic Use Only for the quantitative measurement of sex hormone binding globulin (SHBG) in human serum or Na heparinized plasma on Tosoh AIA System Analyzers. The ST AIA-PACK SHBG assay is intended for use as an aid in the diagnosis of androgen disorders.
The ST AIA-PACK SHBG Calibrator Set is intended for In Vitro Diagnostic Use Only for the calibration of the ST AIA-PACK SHBG assay.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K143075 · printed Nov 6, 2026
Cite this page
510(k) Report. “K143075: ST AIA-PACK SHBG, ST AIA-PACK SHBG Calibrator Set.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K143075
Report an extraction error
Are you the manufacturer?
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