510(k) · Cleared
ClearedElecsys CA 15-3 II
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Roche Diagnostics · MOI System, Test, Immunological, Antigen, Tumor
Cleared on Feb 20, 2018 as substantially equivalent to K001468 (Roche Diagnostics Corp., 2000) after a 264-day review. Its family tree reaches back 1 generation to 2000. 1 later device descends from it.
- Decided
- Feb 20, 2018
- Review
- 264 days
- Class
- Class II
- Product code
- MOI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K001468 (2000). 1 later device descends from it, 1 citing it directly.
Most influential descendants
Showing 1 of 1 · See all- K181492Elecsys CA 15-3 IIRoche Diagnostics · 2018 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K001468 | Elecsys CA 15-3 Test System | Roche Diagnostics Corp. | 2000 | — |
| 0 (this device) | K171605 | Elecsys CA 15-3 II | Roche Diagnostics | 2018 | — |
| +1 | K181492 | Elecsys CA 15-3 II | Roche Diagnostics | 2018 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 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 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 |
|---|---|---|---|
| * | K001468 | Elecsys CA 15-3 Test SystemSummary page 4…System, Test, Immunological, Antigen, Tumor Product Codes, MOI, 866.6010 Regulation Numbers Predicate Devices CA 15-3 II Assay (K001468) For the Elecsys CA 15-3 II, the establishment registration number for Roche… | 2000 |
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 |
|---|---|---|---|
| K181492 | Elecsys CA 15-3 II | 2018 | 0 |
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.
- Of its descendants, K181492 (Roche Diagnostics, 2018) has gone furthest, with 0 descendants of its own.
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. 2018, this device’s year, is highlighted.
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?
Immunological in vitro assay for quantitative determination of CA 15‑3 in human serum and Li-heparin plasma to aid in the management of breast cancer patients. In conjunction with other clinical and diagnostic procedures, serial testing with this assay is an aid
▪ in the early detection of recurrence in previously treated stage II and III breast cancer patients
▪ for monitoring response to therapy in metastatic breast cancer patients
The electrochemiluminescence immunoassay “ECLIA” is intended for use on cobas e immunoassay analyzers.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K171605 · printed Nov 6, 2026
Cite this page
510(k) Report. “K171605: Elecsys CA 15-3 II.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K171605
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