510(k) · Cleared
Recalled · 2010Access Sex Hormone Binding Globulin Reagent, Access Sex Hormone Binding Globulin Calibrators and Access Sex Hormone Bind
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Beckman Coulter, Inc. · CDZ Radioimmunoassay, Testosterones And Dihydrotestosterone
Cleared on Aug 27, 2009 as substantially equivalent to K941797 (Diagnostic Products Corp., 1994) after a 241-day review. Its family tree reaches back 1 generation to 1994. 2 later devices descend from it. It has been recalled once.
- Decided
- Aug 27, 2009
- Review
- 241 days
- Class
- Class I
- Product code
- CDZ
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 1 generation to K941797 (1994). 2 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK941797 Immulite SHBGDiagnostic Products Corp. · 1994
- This deviceK083867 Access Sex Hormone Binding Globulin Reagent, Access Sex Hormone…Beckman Coulter, Inc. · 2009
- Descendant · cites it directly · 0 of its ownK233480 Access SHBGBeckman Coulter, Inc. · 2024
- Descendant · cites it directly · 0 of its ownK182521 FastPack IP Sex Hormone Binding Globulin ImmunoassayQualigen, Inc. · 2019 · Recalled
Most influential descendants
Showing 2 of 2 · See allView 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) | K083867 | Access Sex Hormone Binding Globulin Reagent, Access Sex Hormone Binding… | Beckman Coulter, Inc. | 2009 | — |
| +1 | K233480 | Access SHBG | Beckman Coulter, Inc. | 2024 | — |
| +1 | K182521 | FastPack IP Sex Hormone Binding Globulin Immunoassay | Qualigen, Inc. | 2019 | 2 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 1 | 0 |
| 2024 | 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 2…the sample is determined from a stored, multi-point calibration curve. Predicate Device: DPC Immulite SHBG ~ (K941797) The IMMULITE SHBG assay and IMMULITE 2000 analyzer are registered trademarks of Siemens Healthcare Diagnostics. Beckman… | 1994 |
What descends from it? (2)
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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jul 26, 2010 | Not classified | Z-0431-2011 | Pending | The recall was initiated because the Instruction for Use (IFU) for Access SHBG does not specify the units of measure to be used when calculating the Free Androgen Index (FAI %). Access SHBG (nmol/L) values and Access Testosterone (ng/mL)… |
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. 2009, 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 Access SHBG assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of Sex Hormone Binding Globulin levels in human serum and plasma using the Access Immunoassay Systems. The Access Sex Hormone Binding Globulin assay is indicated for use in the assessment of androgen disorders.
The Access SHBG Calibrators are intended to calibrate the Access SHBG assay for the quantitative determination of Sex Hormone Binding Globulin levels in human serum and plasma using the Access Immunoassay Systems.
The Access SHBG QC is intended for monitoring system performance of the Access SHBG assay.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K083867 · printed Nov 4, 2026
Cite this page
510(k) Report. “K083867: Access Sex Hormone Binding Globulin Reagent, Access Sex Hormone Binding Globulin Calibrators and Access Sex Hormone Bind.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K083867
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