510(k) · Cleared
ClearedAtellica IM CA 19-9 II
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Siemens Healthcare Diagnostics, Inc. · NIG System, Test, Carbohydrate Antigen (Ca19-9), For Monitoring And Management Of Pancreatic Cancer
Cleared on Aug 10, 2026 as substantially equivalent to K031393 (Bayer Healthcare, LLC, 2003) after a 270-day review. Its family tree reaches back 2 generations to 2002.
- Decided
- Aug 10, 2026
- Review
- 270 days
- Class
- Class II
- Product code
- NIG
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K020566 (2002). 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 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 K231525 VITROS Immunodiagnostic Products CA 19-9TM…score 6.1 · 2 generations · no Class I recall
- #2 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 |
|---|---|---|---|
| * | K031393 | Bayer Advia Centaur CA 19-9 AssaySummary page 7…Device and Comparison The predicate device for the Atellica IM CA 19-9 II assay is the ADVIA Centaur CA 19-9 assay, which was submitted and cleared by FDA under 510(k), K031393, on June 24, 2003. Details for the predicate device are outlined below. Predicate Device… | 2003 |
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 24 years and passes through 3 companies; a new generation was cleared every 23.1 years on median.
- 1 of the 2 ancestors has a recall of any class.
- 1 other device also cites its predicate K031393.
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. 2026, this device’s year, is highlighted.
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 Atellica IM CA 19-9 II (CA 19-9 II) assay is an in vitro diagnostic immunoassay for the quantitative measurement of the CA 19-9 tumor-associated antigen in human serum and plasma (EDTA and lithium heparin) using the Atellica IM Analyzer. This assay 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…
Read the full statement (133 words)
The Atellica IM CA 19-9 II (CA 19-9 II) assay is an in vitro diagnostic immunoassay for the quantitative measurement of the CA 19-9 tumor-associated antigen in human serum and plasma (EDTA and lithium heparin) using the Atellica IM Analyzer. This assay 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 at some point in their disease process exceeding the upper limit of normal determined for the apparently healthy cohort. CA 19-9 values must be interpreted in conjunction with all other 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/K253528 · printed Nov 4, 2026
Cite this page
510(k) Report. “K253528: Atellica IM CA 19-9 II.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K253528
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026