510(k) · Cleared
ClearedADVIA Centaur Testosterone II (TSTII), ADVIA Centaur SHBG
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Siemens Healthcare Diagnostics, Inc. · CDZ Radioimmunoassay, Testosterones And Dihydrotestosterone
Cleared on Aug 28, 2019 as substantially equivalent to K151986 (Siemens Healthcare Diagnostics, Inc., 2016) after a 79-day review. Its family tree reaches back 6 generations to 1992.
- Decided
- Aug 28, 2019
- Review
- 79 days
- Class
- Class I
- Product code
- CDZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K924862 (1992). 16 ancestors in all, the oldest K924863 (1992). No later device cites it as a predicate yet.
- Root · 6 generations backK924862 Aia-Pack HCG Calibration Verification Test SetTosoh Medics, Inc. · 1992
- 5 generations backK963147 Elecsys Calcheck TSHBoehringer Mannheim Corp. · 1996
- 4 generations backK974383 Elecsys Calcheck Vitamin B12Boehringer Mannheim Corp. · 1997
- 3 generations backK060755 Elecsys Vitamin B12 Immunoassay, Calset II and CalcheckRoche Diagnostics Corp. · 2006
- 2 generations backK140505 Advia Centaur Vitamin B12 Master Curve Material, Total HCG Master…Siemens Healthcare Diagnostics, Inc. · 2014
- 1 generation backK151986 ADVA Centaur Testosterone II (TSTII), ADVA Centaur Testosterone II…Siemens Healthcare Diagnostics, Inc. · 2016
- This deviceK191533 ADVIA Centaur Testosterone II (TSTII), ADVIA Centaur SHBGSiemens Healthcare Diagnostics, Inc. · 2019
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K924862 | Aia-Pack HCG Calibration Verification Test Set | Tosoh Medics, Inc. | 1992 | — |
| −5 | K963147 | Elecsys Calcheck TSH | Boehringer Mannheim Corp. | 1996 | — |
| −4 | K974383 | Elecsys Calcheck Vitamin B12 | Boehringer Mannheim Corp. | 1997 | — |
| −3 | K060755 | Elecsys Vitamin B12 Immunoassay, Calset II and Calcheck | Roche Diagnostics Corp. | 2006 | — |
| −2 | K140505 | Advia Centaur Vitamin B12 Master Curve Material, Total HCG Master Curve… | Siemens Healthcare Diagnostics, Inc. | 2014 | — |
| −1 | K151986 | ADVA Centaur Testosterone II (TSTII), ADVA Centaur Testosterone II (TSTII)… | Siemens Healthcare Diagnostics, Inc. | 2016 | — |
| 0 (this device) | K191533 | ADVIA Centaur Testosterone II (TSTII), ADVIA Centaur SHBG | Siemens Healthcare Diagnostics, Inc. | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 1 | 0 |
| 1994 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 3 | 0 |
| 2001 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 2 | 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 |
|---|---|---|---|
| * | K151986 | ADVA Centaur Testosterone II (TSTII), ADVA Centaur Testosterone II (TSTII) Master Curve…Summary page 5…ess 4. Predicate Device Information ADVIA Centaur® Testosterone II (TSTII) Predicate Device Name: ADVIA Centaur® Testosterone II (TSTII) 510(k) Number: K151986 The re-standardized ADVIA Centaur® Testosterone II (TSTII) is substantially equivalent to the ADVIA Centaur® Testosterone II (TST… | 2016 |
| † | K091867 | Advia Centaur SHBG Readypack, Low and High Calibrators and Master Curve Material, Models… | 2010 |
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 27 years and passes through 4 companies; a new generation was cleared every 3.7 years on median.
- 1 of the 16 ancestors has a recall of any class.
- 1 other device also cites its predicate K151986.
How does its category compare?
All CDZ devicesCDZ Radioimmunoassay, Testosterones And Dihydrotestosterone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, 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 ADVIA Centaur® Testosterone II (TSTII) assay is for in vitro diagnostic use in the quantitative determination of total testosterone (bound and unbound) in human serum and plasma using the ADVIA Centaur XP system. Measurements of testosterone are used in the diagnosis and treatment of disorders involving the male sex hormones (androgens), including primary and secondary hypogonadism, delayed or precocious puberty, impotence in males and, in females…
Read the full statement (133 words)
The ADVIA Centaur® Testosterone II (TSTII) assay is for in vitro diagnostic use in the quantitative determination of total testosterone (bound and unbound) in human serum and plasma using the ADVIA Centaur XP system.
Measurements of testosterone are used in the diagnosis and treatment of disorders involving the male sex hormones (androgens), including primary and secondary hypogonadism, delayed or precocious puberty, impotence in males and, in females, hirsutism (excessive hair) and virilization (masculinization) due to tumors, polycystic ovaries, and adrenogenital syndromes.
ADVIA Centaur® SHBG
The ADVIA Centaur® SHBG assay is an in vitro diagnostic immunoassay for the quantitative determination of sex hormone-binding globulin (SHBG) in human serum and plasma using the ADVIA Centaur XP system.
The ADVIA Centaur SHBG assay is intended for use as an aid in the diagnosis of androgen disorders.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K191533 · printed Nov 6, 2026
Cite this page
510(k) Report. “K191533: ADVIA Centaur Testosterone II (TSTII), ADVIA Centaur SHBG.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K191533
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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