510(k) · Cleared
ClearedElecsys SHBG Immunoassay
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Roche Diagnostics Corp. · CDZ Radioimmunoassay, Testosterones And Dihydrotestosterone
Cleared on Aug 5, 2003 as substantially equivalent to K941797 (Diagnostic Products Corp., 1994) after a 63-day review. Its family tree reaches back 1 generation to 1994. 4 later devices descend from it.
- Decided
- Aug 5, 2003
- Review
- 63 days
- Class
- Class I
- Product code
- CDZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K941797 (1994). 4 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK941797 Immulite SHBGDiagnostic Products Corp. · 1994
- This deviceK031717 Elecsys SHBG ImmunoassayRoche Diagnostics Corp. · 2003
- Descendant · cites it directly · 2 of its ownK060818 Architect SHBG Reagent Kit, Architect SHBG Calibrator Kit, and…Biokit, S.A. · 2007 · Recalled
- Descendant · 2 generations on · 0 of its ownK152185 Architect SHBGBiokit, S.A. · 2016
- Descendant · 2 generations on · 0 of its ownK143075 ST AIA-PACK SHBG, ST AIA-PACK SHBG Calibrator SetTosoh Bioscience, Inc. · 2015 · Recalled
- Descendant · cites it directly · 0 of its ownK102814 Elecysys SHBGRoche Diagnostics · 2011
Most influential descendants
Showing 4 of 4 · See all- K060818Architect SHBG Reagent Kit, Architect SHBG Calibrator Kit, and Architect SHBG Control…Biokit, S.A. · 2007 · cites it directly2descendants
- K152185Architect SHBGBiokit, S.A. · 2016 · 2 generations on0descendants
- K143075ST AIA-PACK SHBG, ST AIA-PACK SHBG Calibrator SetTosoh Bioscience, Inc. · 2015 · 2 generations on0descendants
- K102814Elecysys SHBGRoche Diagnostics · 2011 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K941797 | Immulite SHBG | Diagnostic Products Corp. | 1994 | — |
| 0 (this device) | 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 |
| +2 | K152185 | Architect SHBG | Biokit, S.A. | 2016 | — |
| +2 | K143075 | ST AIA-PACK SHBG, ST AIA-PACK SHBG Calibrator Set | Tosoh Bioscience, Inc. | 2015 | 1 |
| +1 | K102814 | Elecysys SHBG | Roche Diagnostics | 2011 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2011 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
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 |
|---|---|---|---|
| * | K941797 | Immulite SHBGSummary page 3…ally equivalent to other devices equivalence legally marketed in the United States. We claim equivalence to the DPC Immulite SHBG cleared under K941797. Both products are intended for use in the quantitative determination of sex hormone binding globulin. Subst… | 1994 |
What descends from it? (4)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
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?
Immunoassay for the in vitro quantitative determination sex hormone binding globulin in human serum and plasma. The Elecsys SHBG Immunoassay is intended for use as an aid in the diagnosis of androgen disorders including hirsuitism, virilization, polycystic ovarian syndrome, adrenogenital syndrome, and hyperandrogenism; the correct interpretation of testosterone and estradiol concentrations; investigation of the androgen-estrogen balance in gonadal and sexual dysfunction; assessment of the peripheral effect of hormones which regulate SHBG concentrations. The electrochemiluminescence immunoassay "ECLIA" is intended for use on the Roche Elecsys family of analyzers.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K031717 · printed Nov 6, 2026
Cite this page
510(k) Report. “K031717: Elecsys SHBG Immunoassay.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K031717
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