510(k) · Cleared
ClearedVitros Immunodiagnostic Products CA 15-3 Calibrators,Vitros Immunodiagnostic Products CA 15-3 Reagent Pack
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ortho-Clinical Diagnostics, Inc. · MOI System, Test, Immunological, Antigen, Tumor
Cleared on Feb 2, 1999 as substantially equivalent to K963803 (Centocor, Inc., 1997) after a 104-day review. Its family tree reaches back 2 generations to 1996.
- Decided
- Feb 2, 1999
- Review
- 104 days
- Class
- Class II
- Product code
- MOI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to P950011 (1996). No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
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 MOI? 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 MOI device
- #1 K240403 Access BR Monitorscore 7.9 · 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 |
|---|---|---|---|
| * | K963803 | Centocor CA 15-3 Ria Model NO. 800-033Summary page 1…DF3-defined antigen in serum or plasma. 3. Comparitor Device The VITROS Immunodiagnostic Products CA 15-3 assay is substantially equivalent to the Centocor CA 15-3 RIA (K963803). 4. Device Description The VITROS Immunodiagnostic System uses luminescence as the signal in the quantitative and semi-quantit… | 1997 |
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 3 years and passes through 3 companies; a new generation was cleared every 1.7 years on median.
- None of the 2 ancestors has a recall.
How does its category compare?
All MOI devicesMOI System, Test, Immunological, Antigen, Tumor: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MOI
2in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · MOI
Too few MOI 510(k)s in any year since 2007 to give a median.
Recalls per year · MOI
2in 2012
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MOI
6in 2025
MAUDE reports naming product code MOI, 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 | — | 1 | 2 |
| 2008 | 0 | — | 0 | 3 |
| 2009 | 0 | — | 0 | 3 |
| 2010 | 0 | — | 0 | 22 |
| 2011 | 1 | — | 0 | 3 |
| 2012 | 0 | — | 2 | 4 |
| 2013 | 0 | — | 0 | 3 |
| 2014 | 0 | — | 0 | 52 |
| 2015 | 0 | — | 0 | 28 |
| 2016 | 0 | — | 0 | 5 |
| 2017 | 0 | — | 0 | 7 |
| 2018 | 2 | — | 0 | 1 |
| 2019 | 1 | — | 0 | 5 |
| 2020 | 2 | — | 0 | 11 |
| 2021 | 0 | — | 0 | 16 |
| 2022 | 0 | — | 0 | 16 |
| 2023 | 0 | — | 0 | 6 |
| 2024 | 2 | — | 0 | 5 |
| 2025 | 0 | — | 0 | 6 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The VITROS®CA 15-3 is an in vitro assay intended for the quantitative measurement of DF3 defined antigen in serum or plasma (EDTA or heparin) from patients previously treated for stage II or stage III breast cancer. Serial test results obtained with the VITROS CA 15-3 assay, in patients who are clinically free of disease, should be used in conjunction with all relevant information derived from diagnostic test, physical examination and full medical…
Read the full statement (112 words)
The VITROS®CA 15-3 is an in vitro assay intended for the quantitative measurement of DF3 defined antigen in serum or plasma (EDTA or heparin) from patients previously treated for stage II or stage III breast cancer. Serial test results obtained with the VITROS CA 15-3 assay, in patients who are clinically free of disease, should be used in conjunction with all relevant information derived from diagnostic test, physical examination and full medical history in accordance with appropriate patient management procedures used for early detection of recurrence. The test is also intended for use as an aid in the management of breast cancer patients with metastatic disease by monitoring progression se to treatment.
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/K983690 · printed Nov 5, 2026
Cite this page
510(k) Report. “K983690: Vitros Immunodiagnostic Products CA 15-3 Calibrators,Vitros Immunodiagnostic Products CA 15-3 Reagent Pack.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K983690
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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