510(k) · Cleared
ClearedArchitect SHBG
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biokit, S.A. · CDZ Radioimmunoassay, Testosterones And Dihydrotestosterone
Cleared on Feb 11, 2016 as substantially equivalent to K060818 (Biokit, S.A., 2007) after a 190-day review. Its family tree reaches back 3 generations to 1994.
- Decided
- Feb 11, 2016
- Review
- 190 days
- Class
- Class I
- Product code
- CDZ
- Recalls
- None
- 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 deviceK152185 Architect SHBGBiokit, S.A. · 2016
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) | K152185 | Architect SHBG | Biokit, S.A. | 2016 | — |
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 4…tion: Class I Reserved Classification Panel: Clinical Chemistry Product Code: CDZ Legally marketed device to which equivalency is claimed: ARCHITECT SHBG assay (K060818) Intended Use/Indications for Use: The ARCHITECT SHBG assay is a chemiluminescent microparticle immunoassay (CMIA) for the… | 2007 |
| † | K983212 | Abbott Architect Testosterone | 1998 |
| † | K120009 | Testosterone Test System; Calibrator; and Quality Control Material (Assayed and Unassayed) | 2012 |
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?
- The line of descent spans 22 years and passes through 3 companies; a new generation was cleared every 8.8 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. 2016, 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?
The ARCHITECT SHBG assay is a chemiluminescent microparticle immunoassay (CMIA) for the quantitative determination of sex hormone binding globulin (SHBG) in human serum and plasma on the ARCHITECT i System.
The ARCHITECT SHBG assay is used as an aid in the diagnosis of androgen disorders.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K152185 · printed Nov 6, 2026
Cite this page
510(k) Report. “K152185: Architect SHBG.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K152185
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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