510(k) · Cleared
ClearedFujirebio Diagnostics CA 19-9 Ria
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Fujirebio Diagnostics,Inc. · NIG System, Test, Carbohydrate Antigen (Ca19-9), For Monitoring And Management Of Pancreatic Cancer
Cleared on May 9, 2002 after a 78-day review. The FDA summary names its predicate without a number. 10 later devices descend from it.
- Decided
- May 9, 2002
- Review
- 78 days
- Class
- Class II
- Product code
- NIG
- Recalls
- None
- Predicates
- 0
10 later devices descend from it, 5 citing it directly.
- This deviceK020566 Fujirebio Diagnostics CA 19-9 RiaFujirebio Diagnostics,Inc. · 2002
- Descendant · cites it directly · 2 of its ownK052000 Architect CA 19-9XR AssayFujirebio Diagnostics,Inc. · 2005 · Recalled
- Descendant · cites it directly · 2 of its ownK031393 Bayer Advia Centaur CA 19-9 AssayBayer Healthcare, LLC · 2003 · Recalled
- Descendant · 2 generations on · 1 of its ownK191973 Lumpipulse G CA19-9-NFujirebio Dianostics, Inc. · 2019
- Descendant · cites it directly · 1 of its ownK052889 Vitros CA 19-9Fujirebio Diagnostics,Inc. · 2005
- Descendant · 2 generations on · 0 of its ownK253528 Atellica IM CA 19-9 IISiemens Healthcare Diagnostics, Inc. · 2026
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- K052000Architect CA 19-9XR AssayFujirebio Diagnostics,Inc. · 2005 · cites it directly2descendants
- K031393Bayer Advia Centaur CA 19-9 AssayBayer Healthcare, LLC · 2003 · cites it directly2descendants
- K191973Lumpipulse G CA19-9-NFujirebio Dianostics, Inc. · 2019 · 2 generations on1descendant
- K052889Vitros CA 19-9Fujirebio Diagnostics,Inc. · 2005 · cites it directly1descendant
- K253528Atellica IM CA 19-9 IISiemens Healthcare Diagnostics, Inc. · 2026 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K020566 | Fujirebio Diagnostics CA 19-9 Ria | Fujirebio Diagnostics,Inc. | 2002 | — |
| +1 | K052000 | Architect CA 19-9XR Assay | Fujirebio Diagnostics,Inc. | 2005 | 1 |
| +1 | K031393 | Bayer Advia Centaur CA 19-9 Assay | Bayer Healthcare, LLC | 2003 | 8 |
| +2 | K191973 | Lumpipulse G CA19-9-N | Fujirebio Dianostics, Inc. | 2019 | — |
| +1 | K052889 | Vitros CA 19-9 | Fujirebio Diagnostics,Inc. | 2005 | — |
| +2 | K253528 | Atellica IM CA 19-9 II | Siemens Healthcare Diagnostics, Inc. | 2026 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 2 | 0 |
| 2005 | 3 | 0 |
| 2011 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2023 | 1 | 0 |
| 2026 | 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 NIG? 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 NIG device
- #1 K253528 Atellica IM CA 19-9 IIscore 12.1 · 2 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 |
|---|---|---|---|
| * | — | Abbott Laboratories AxSYM® CEA MEIA Named without a submission number |
What descends from it? (10)
5 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- Of its descendants, K052000 (Fujirebio Diagnostics,Inc., 2005) has gone furthest, with 2 descendants of its own.
How does its category compare?
All NIG devicesNIG System, Test, Carbohydrate Antigen (Ca19-9), For Monitoring And Management Of Pancreatic Cancer: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · NIG
1in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · NIG
Too few NIG 510(k)s in any year since 2007 to give a median.
Recalls per year · NIG
2in 2016
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · NIG
98in 2025
MAUDE reports naming product code NIG, 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 | 0 | — | 0 | 6 |
| 2008 | 0 | — | 0 | 9 |
| 2009 | 0 | — | 0 | 11 |
| 2010 | 0 | — | 1 | 12 |
| 2011 | 1 | — | 1 | 8 |
| 2012 | 0 | — | 1 | 1,785 |
| 2013 | 0 | — | 0 | 182 |
| 2014 | 0 | — | 0 | 117 |
| 2015 | 0 | — | 0 | 29 |
| 2016 | 0 | — | 2 | 69 |
| 2017 | 0 | — | 0 | 98 |
| 2018 | 0 | — | 0 | 58 |
| 2019 | 1 | — | 0 | 135 |
| 2020 | 1 | — | 0 | 93 |
| 2021 | 0 | — | 0 | 69 |
| 2022 | 0 | — | 0 | 83 |
| 2023 | 1 | — | 0 | 129 |
| 2024 | 0 | — | 0 | 121 |
| 2025 | 0 | — | 0 | 98 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The Fujirebio Diagnostics CA 19-9™ RIA, an in vitro diagnostic test for the quantitative measurement of the CA 19-9 tumor associated antigen, in human serum or plasma, is indicated for the serial measurement of CA 19-9 to aid in the management of patients diagnosed with cancers of the exocrine pancreas. The test is useful as an aid in:
Monitoring of disease status in those patients having confirmed pancreatic cancer who have levels of serum or plasma CA 19-9 above the cutoff, at the time of diagnosis.
CA 19-9 values must be interpreted in conjunction with all other available clinical and laboratory data before a medical decision is determined.
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/K020566 · printed Nov 5, 2026
Cite this page
510(k) Report. “K020566: Fujirebio Diagnostics CA 19-9 Ria.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K020566
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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