510(k) · Cleared
Recalled · Class II · 2013Vitros Immunodiagnostic Products CA 125 II Calibrators, Vitros Immunodiagnostic Products CA 125 II Reagent Pack
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ortho-Clinical Diagnostics, Inc. · LTK Test, Epithelial Ovarian Tumor-Associated Antigen (Ca125)
Cleared on May 14, 1999 as substantially equivalent to K972162 (Boehringer Mannheim Corp., 1998) after a 193-day review. Its family tree reaches back 1 generation to 1998. 1 later device descends from it. It has been recalled once.
- Decided
- May 14, 1999
- Review
- 193 days
- Class
- Class II
- Product code
- LTK
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 1 generation to K972162 (1998). 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK972162 Elecsys CA 125 IIBoehringer Mannheim Corp. · 1998
- This deviceK983875 Vitros Immunodiagnostic Products CA 125 II Calibrators, Vitros…Ortho-Clinical Diagnostics, Inc. · 1999
- Descendant · cites it directly · 0 of its ownK221355 VITROS Immuodiagnostic Products CA 125 II Reagent PackOrtho Clinical Diagnostics · 2022
Most influential descendants
Showing 1 of 1 · See all- K221355VITROS Immuodiagnostic Products CA 125 II Reagent PackOrtho Clinical Diagnostics · 2022 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K972162 | Elecsys CA 125 II | Boehringer Mannheim Corp. | 1998 | — |
| 0 (this device) | K983875 | Vitros Immunodiagnostic Products CA 125 II Calibrators, Vitros… | Ortho-Clinical Diagnostics, Inc. | 1999 | — |
| +1 | K221355 | VITROS Immuodiagnostic Products CA 125 II Reagent Pack | Ortho Clinical Diagnostics | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 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 LTK? 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 LTK device
- #1 K240479 Access OV Monitorscore 7.3 · 1 generation · 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 |
|---|---|---|---|
| * | K972162 | Elecsys CA 125 IISummary page 1…n in serum or plasma. 3. Predicate Device The VITROS Immunodiagnostic Products CA 125 II assay is substantially equivalent to the Bochringer Mannheim Elecsys CA 125 T (K972162). 4. Device Description The VITROS Immunodiagnostic System uses lumincscence as the signal in the quantitative and semi-quantit… | 1998 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K221355 | VITROS Immuodiagnostic Products CA 125 II Reagent Pack | 2022 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Oct 9, 2013 | Class II | Z-0525-2014 | Under Investigation by firm | Ortho Clinical Diagnostics issued a Product Correction Notification for VITROS Immunodiagnostic Products CA 125 II Reagent Pack and Calibrators due to a positive shift in patient results. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
How does its category compare?
All LTK devicesLTK Test, Epithelial Ovarian Tumor-Associated Antigen (Ca125): FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LTK
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · LTK
Too few LTK 510(k)s in any year since 2007 to give a median.
Recalls per year · LTK
1in 2013
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LTK
4in 2025
MAUDE reports naming product code LTK, 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 | 4 |
| 2008 | 0 | — | 0 | 9 |
| 2009 | 2 | — | 0 | 31 |
| 2010 | 0 | — | 3 | 12 |
| 2011 | 1 | — | 0 | 5 |
| 2012 | 0 | — | 0 | 33 |
| 2013 | 0 | — | 1 | 14 |
| 2014 | 0 | — | 0 | 30 |
| 2015 | 2 | — | 0 | 11 |
| 2016 | 0 | — | 0 | 4 |
| 2017 | 0 | — | 0 | 15 |
| 2018 | 0 | — | 0 | 8 |
| 2019 | 0 | — | 0 | 15 |
| 2020 | 1 | — | 0 | 5 |
| 2021 | 0 | — | 0 | 2 |
| 2022 | 1 | — | 0 | 2 |
| 2023 | 1 | — | 0 | 6 |
| 2024 | 1 | — | 0 | 6 |
| 2025 | 0 | — | 0 | 4 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Vitros® CA 125 I is an in vitro assay intended for the quantitative measurement of OC 125 defined antigen in the serum or plasma (EDTA or heparin). The Vitros CA 125 1I assay is to be used as an aid in monitoring response to therapy for patients with epithelial ovarian cancer. Serial testing for patient CA 125 assay values should be used in conjuction with other clinical methods used for monitoring ovarian cancer.
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/K983875 · printed Nov 6, 2026
Cite this page
510(k) Report. “K983875: Vitros Immunodiagnostic Products CA 125 II Calibrators, Vitros Immunodiagnostic Products CA 125 II Reagent Pack.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K983875
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