510(k) · Cleared
Recalled · Class II · 2018ST Aia-Pack CA 19-9
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Tosoh Corp. · NIG System, Test, Carbohydrate Antigen (Ca19-9), For Monitoring And Management Of Pancreatic Cancer
Cleared on Dec 23, 2002 after an 87-day review. FDA’s file for it is a 510(k) statement, which names no predicate. It has been recalled once.
- Decided
- Dec 23, 2002
- Review
- 87 days
- Class
- Class II
- Product code
- NIG
- Recalls
- 1
- Predicates
- 0
FDA’s file for it is a 510(k) statement, which names no predicate.
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Mar 5, 2018 | Class II | Z-2069-2018 | Device Design | Asfotase Alfa (Strensiq) interferes with certain Tosoh assays which potentially causes falsely increased or falsely decreased immunoassay test results, depending upon the assay. |
No ancestor or descendant has a Class I recall.
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?
ST AIA-PACK™ CA 19-9 is designed for IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement of CA 19-9 tumor associated antigen in human serum on TOSOH AIA Nex4A and AlAdOOll Immunoassay analyzers. Serial testing using the ST AIA-PACK™ CA 19-9 is to be used as an aid in monitoring the disease status in patients who have been diagnosed with pancreatic cancer and who show measurable CA 19-9 results over the course of their disease. Results of CA 19-9 testing should be used in conjunction with other clinical methods that are standard of care for monitoring disease status in these patients.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K023240 · printed Nov 6, 2026
Cite this page
510(k) Report. “K023240: ST Aia-Pack CA 19-9.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K023240
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026