510(k) · Cleared
ClearedImmulite SHBG
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Diagnostic Products Corp. · CDZ Radioimmunoassay, Testosterones And Dihydrotestosterone
Cleared on Oct 31, 1994 after a 202-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 8 later devices descend from it.
- Decided
- Oct 31, 1994
- Review
- 202 days
- Class
- Class I
- Product code
- CDZ
- Recalls
- None
- Predicates
- 0
8 later devices descend from it, 2 citing it directly.
- This deviceK941797 Immulite SHBGDiagnostic Products Corp. · 1994
- Descendant · cites it directly · 4 of its ownK031717 Elecsys SHBG ImmunoassayRoche Diagnostics Corp. · 2003
- Descendant · cites it directly · 2 of its ownK083867 Access Sex Hormone Binding Globulin Reagent, Access Sex Hormone…Beckman Coulter, Inc. · 2009 · Recalled
- Descendant · 2 generations on · 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 ownK233480 Access SHBGBeckman Coulter, Inc. · 2024
- Descendant · 2 generations on · 0 of its ownK182521 FastPack IP Sex Hormone Binding Globulin ImmunoassayQualigen, Inc. · 2019 · Recalled
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K031717Elecsys SHBG ImmunoassayRoche Diagnostics Corp. · 2003 · cites it directly4descendants
- K083867Access Sex Hormone Binding Globulin Reagent, Access Sex Hormone Binding Globulin…Beckman Coulter, Inc. · 2009 · cites it directly2descendants
- K060818Architect SHBG Reagent Kit, Architect SHBG Calibrator Kit, and Architect SHBG Control…Biokit, S.A. · 2007 · 2 generations on2descendants
- K233480Access SHBGBeckman Coulter, Inc. · 2024 · 2 generations on0descendants
- K182521FastPack IP Sex Hormone Binding Globulin ImmunoassayQualigen, Inc. · 2019 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K941797 | Immulite SHBG | Diagnostic Products Corp. | 1994 | — |
| +1 | K031717 | Elecsys SHBG Immunoassay | Roche Diagnostics Corp. | 2003 | — |
| +1 | K083867 | Access Sex Hormone Binding Globulin Reagent, Access Sex Hormone Binding… | Beckman Coulter, Inc. | 2009 | 1 |
| +2 | K060818 | Architect SHBG Reagent Kit, Architect SHBG Calibrator Kit, and Architect SHBG… | Biokit, S.A. | 2007 | 1 |
| +2 | K233480 | Access SHBG | Beckman Coulter, Inc. | 2024 | — |
| +2 | K182521 | FastPack IP Sex Hormone Binding Globulin Immunoassay | Qualigen, Inc. | 2019 | 2 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2007 | 1 | 0 |
| 2009 | 1 | 0 |
| 2011 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2019 | 1 | 0 |
| 2024 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (8)
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?
- Of its descendants, K031717 (Roche Diagnostics Corp., 2003) has gone furthest, with 4 descendants of its own.
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 | — |
https://510kreport.com/device/K941797 · printed Nov 6, 2026
Cite this page
510(k) Report. “K941797: Immulite SHBG.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K941797
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026