510(k) · Cleared
Recalled · Class II · 2018Dimension Vista LOCI Total Testosterone Flex reagent cartridge, Dimension Vista Testosterone Calibrator
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 Feb 11, 2016 as substantially equivalent to K093421 (Roche Diagnostics Corp., 2010) and 1 other predicate after a 248-day review. Its family tree reaches back 2 generations to 1997. It has been recalled once.
- Decided
- Feb 11, 2016
- Review
- 248 days
- Class
- Class I
- Product code
- CDZ
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 2 generations to K964889 (1997). 3 ancestors in all. No later device cites it as a predicate yet.
- Root · 2 generations backK964889 Elecsys Testosterone AssayBoehringer Mannheim Corp. · 1997
- 1 generation backK093421 Elecsys Testosterone II ImmunoassayRoche Diagnostics Corp. · 2010
- This deviceK151529 Dimension Vista LOCI Total Testosterone Flex reagent cartridge…Siemens Healthcare Diagnostics, Inc. · 2016
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K964889 | Elecsys Testosterone Assay | Boehringer Mannheim Corp. | 1997 | — |
| −1 | K093421 | Elecsys Testosterone II Immunoassay | Roche Diagnostics Corp. | 2010 | — |
| 0 (this device) | K151529 | Dimension Vista LOCI Total Testosterone Flex reagent cartridge, Dimension… | Siemens Healthcare Diagnostics, Inc. | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 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? (2)
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 |
|---|---|---|---|
| * | K093421 | Elecsys Testosterone II ImmunoassaySummary page 6…Chemistry 3. Predicate Device Assay: Roche Diagnostics Corp. Device Name: Elecsys® Testosterone II Immunoassay 510(k) Number: K093421 Regulatory Class: I (21 CFR §862.1680, Testosterone test system) Classification Product Code: CDZ Panel: Clinic… | 2010 |
| * | K003411 | Elecsys Testosterone Calset IISummary page 6…oduct Code: CDZ Panel: Clinical Chemistry Calibrator: Roche Diagnostics Corp. Device Name: Elecsys® Testosterone Calset II 510(k) Number: K003411 Regulatory Class: II (21 CFR §862.1150, Calibrator) Classification Product Code: JIT Panel: Clinical Chemistry… | 2001 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Mar 21, 2018 | Class II | Z-2438-2018 | Under Investigation by firm | The diluent may have an incomplete slit on the septum in the cap of the vial. A diluent cap with a defective septum has the potential to cause erroneously elevated results if a sample is autodiluted onboard the system, due to a reduced… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 19 years and passes through 3 companies; a new generation was cleared every 13.1 years on median.
- None of the 3 ancestors has a recall.
- 4 other devices also cite its predicate K093421.
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 Dimension Vista® LOCI Total Testosterone Flex® reagent cartridge is an in vitro diagnostic test for the quantitative measurement of total testosterone in human serum and plasma on the Dimension Vista® 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 (104 words)
The Dimension Vista® LOCI Total Testosterone Flex® reagent cartridge is an in vitro diagnostic test for the quantitative measurement of total testosterone in human serum and plasma on the Dimension Vista® 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.
The Dimension Vista® Testosterone Calibrator is an in vitro diagnostic product for the calibration of the Total Testosterone (TTST) assay on the Dimension Vista® System.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K151529 · printed Nov 6, 2026
Cite this page
510(k) Report. “K151529: Dimension Vista LOCI Total Testosterone Flex reagent cartridge, Dimension Vista Testosterone Calibrator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K151529
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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