510(k) · Cleared
ClearedVitros Immunodiagnostic Products Testosterone Assay
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ortho-Clinical Diagnostics, Inc. · JJY Multi-Analyte Controls, All Kinds (Assayed)
Cleared on Nov 4, 1998 as substantially equivalent to K813401 (Diagnostic Products Corp., 1981) after a 28-day review. Its family tree reaches back 1 generation to 1981.
- Decided
- Nov 4, 1998
- Review
- 28 days
- Class
- Class I
- Product code
- JJY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K813401 (1981). No later device cites it as a predicate yet.
- Root · 1 generation backK813401 Coat-a-Count Testosterone Ria KitDiagnostic Products Corp. · 1981
- This deviceK983507 Vitros Immunodiagnostic Products Testosterone AssayOrtho-Clinical Diagnostics, Inc. · 1998
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K813401 | Coat-a-Count Testosterone Ria Kit | Diagnostic Products Corp. | 1981 | — |
| 0 (this device) | K983507 | Vitros Immunodiagnostic Products Testosterone Assay | Ortho-Clinical Diagnostics, Inc. | 1998 | — |
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 JJY? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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 |
|---|---|---|---|
| * | K813401 | Coat-a-Count Testosterone Ria KitSummary page 1…asma (EDTA or heparin). 3. Predicate Device The VITROS Immunodiagnostic Products TESTOSTERONE assay is substantially equivalent to DPC Coat-A-Count Testosterone assay (K813401). 4. Device Description The VITROS Immunodiagnostic System uses luminescence as the signal in the quantitative and semi-quantit… | 1981 |
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?
- Its one ancestor has no recall.
- 1 other device also cites its predicate K813401.
How does its category compare?
All JJY devicesJJY Multi-Analyte Controls, All Kinds (Assayed): FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · JJY
3in 2017
2026 to Oct 25, outlined.
Median 510(k) review, days · JJY
78in 2017
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JJY
2in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JJY
13in 2025
MAUDE reports naming product code JJY, 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 | 11 | 49 | 5 | 2 |
| 2008 | 7 | 54 | 0 | 1 |
| 2009 | 8 | 80 | 2 | 3 |
| 2010 | 10 | 109 | 6 | 3 |
| 2011 | 14 | 120 | 1 | 6 |
| 2012 | 13 | 40 | 3 | 20 |
| 2013 | 16 | 82 | 2 | 5 |
| 2014 | 10 | 49 | 2 | 4 |
| 2015 | 4 | 153 | 1 | 4 |
| 2016 | 1 | — | 3 | 13 |
| 2017 | 3 | 78 | 4 | 12 |
| 2018 | 0 | — | 3 | 7 |
| 2019 | 0 | — | 4 | 1 |
| 2020 | 0 | — | 6 | 7 |
| 2021 | 0 | — | 0 | 1 |
| 2022 | 0 | — | 3 | 0 |
| 2023 | 0 | — | 3 | 4 |
| 2024 | 0 | — | 0 | 1 |
| 2025 | 0 | — | 2 | 13 |
| 2026 | 0 | — | 1 | — |
What is it indicated for?
For the in vitro quantitative measurement of testosterone in human serum and plasma (EDTA or heparin).
For in vitro use in the calibration of the Vitros Immunodiagnostic System for the quantitative measurement of testosterone in human serum and plasma (EDTA or heparin).
For in vitro use in monitoring the performance of the Vitros Immunodiagnostic System when used for the measurement of testosterone.
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/K983507 · printed Nov 4, 2026
Cite this page
510(k) Report. “K983507: Vitros Immunodiagnostic Products Testosterone Assay.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K983507
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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