510(k) · Cleared
ClearedLIAISON Calprotectin, LIAISON Calprotectin Control Set, LIAISON Calprotectin Calibration Verifiers, LIAISON Q.S.E.T. Buffer, LIAISON Q.S.E.T. Device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
DiaSorin, Inc. · NXO Calprotectin, Fecal
Cleared on Dec 26, 2018 as substantially equivalent to DEN060001 (Genova Diagnostics, 2006) and 1 other predicate after a 90-day review. Its family tree reaches back 4 generations to 1995. 1 later device descends from it.
- Decided
- Dec 26, 2018
- Review
- 90 days
- Class
- Class II
- Product code
- NXO
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K954418 (1995). 8 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 4 generations backK954418 Intact Parathyroid Hormone (PTH) Immunoassay (Modification)Nichols Institute Diagnostics · 1995
- 3 generations backK020217 Acs:180 and Advia Centaur Ipth ImmunoassayBayer Diagnostics Corp. · 2002 · Recalled
- 2 generations backK132515 Liaison N-Tact PTH Gen II, Control Set, Calibration VerifiersDiaSorin, Inc. · 2013
- 1 generation backK141463 Liason XL1,25 Dihydroxyvitamin D; Control Set, Calibration VerifiersDiaSorin, Inc. · 2014
- This deviceK182698 LIAISON Calprotectin, LIAISON Calprotectin Control Set, LIAISON…DiaSorin, Inc. · 2018
- Descendant · cites it directly · 0 of its ownK213858 LIAISON Calprotectin, LIAISON Q.S.E.T. Device PlusDiaSorin, Inc. · 2022 · Recalled
Most influential descendants
Showing 1 of 1 · See all- K213858LIAISON Calprotectin, LIAISON Q.S.E.T. Device PlusDiaSorin, Inc. · 2022 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K954418 | Intact Parathyroid Hormone (PTH) Immunoassay (Modification) | Nichols Institute Diagnostics | 1995 | — |
| −3 | K020217 | Acs:180 and Advia Centaur Ipth Immunoassay | Bayer Diagnostics Corp. | 2002 | 4 |
| −2 | K132515 | Liaison N-Tact PTH Gen II, Control Set, Calibration Verifiers | DiaSorin, Inc. | 2013 | — |
| −1 | K141463 | Liason XL1,25 Dihydroxyvitamin D; Control Set, Calibration Verifiers | DiaSorin, Inc. | 2014 | — |
| 0 (this device) | K182698 | LIAISON Calprotectin, LIAISON Calprotectin Control Set, LIAISON Calprotectin… | DiaSorin, Inc. | 2018 | — |
| +1 | K213858 | LIAISON Calprotectin, LIAISON Q.S.E.T. Device Plus | DiaSorin, Inc. | 2022 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2004 | 1 | 0 |
| 2006 | 1 | 0 |
| 2009 | 1 | 0 |
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 NXO? 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 NXO device
- #1 K232057 BÜHLMANN fCAL® turbo and CALEX® Capscore 8.3 · 6 generations · no Class I recall
- #2 Held for the reportin the report
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | DEN060001 | Phical TestSummary page 4…JJX PREDICATE DEVICES : PhiCalTM Test Fecal Calprotectin Immunoassay DEN060001 DEVICE DESCRIPTION: INTENDED USE: The DiaSorin LIAISON® Calprotectin assay is an in vitro diagnostic chemiluminescent immunoass… | 2006 |
| * | K141463 | Liason XL1,25 Dihydroxyvitamin D; Control Set, Calibration VerifiersSummary page 8…n D Characteristic LIAISON® Calprotectin Calibration Verifiers (K141463) ® The DiaSorin LIAISON Calprotectin Assayed qu… | 2014 |
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 |
|---|---|---|---|
| K213858 | LIAISON Calprotectin, LIAISON Q.S.E.T. Device Plus | 2022 | 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?
- The line of descent spans 23 years and passes through 3 companies; a new generation was cleared every 6.4 years on median.
- 2 of the 8 ancestors have a recall of any class.
- Of its descendants, K213858 (DiaSorin, Inc., 2022) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate DEN060001.
How does its category compare?
All NXO devicesNXO Calprotectin, Fecal: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, this device’s year, is highlighted.
FDA decisions per year · NXO
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · NXO
90in 2019
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · NXO
2in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · NXO
1in 2022
MAUDE reports naming product code NXO, 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 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 1 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 1 | — | 0 | 0 |
| 2017 | 1 | — | 0 | 0 |
| 2018 | 3 | 90 | 0 | 0 |
| 2019 | 5 | 90 | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 1 | — | 0 | 1 |
| 2023 | 1 | — | 0 | 0 |
| 2024 | 1 | — | 1 | 0 |
| 2025 | 0 | — | 2 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The DiaSorin LIAISON® Calprotectin assay is an in vitro diagnostic chemiluminescent immunoassay (CLIA) intended for the quantitative measurement, in human stool, of fecal calprotectin, a neutrophilic protein that is a marker of mucosal inflammation. The LIAISON® Calprotectin assay can be used as an aid in the diagnosis of inflammatory bowel diseases (IBD), specifically Crohn’s disease and ulcerative colitis, and as an aid in differentiation of IBD from…
Read the full statement (130 words)
The DiaSorin LIAISON® Calprotectin assay is an in vitro diagnostic chemiluminescent immunoassay (CLIA) intended for the quantitative measurement, in human stool, of fecal calprotectin, a neutrophilic protein that is a marker of mucosal inflammation. The LIAISON® Calprotectin assay can be used as an aid in the diagnosis of inflammatory bowel diseases (IBD), specifically Crohn’s disease and ulcerative colitis, and as an aid in differentiation of IBD from irritable bowel syndrome (IBS). Test results are to be used in conjunction with information obtained from the patients’ clinical evaluation and other diagnostic procedures.
The test has to be performed on the LIAISON® XL Analyzer.
The DiaSorin LIAISON® Q.S.E.T. Device (Quantitative Stool Extraction and Test) is intended for use in the preparation of human stool specimens for testing in the LIAISON® Calprotectin assay.
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/K182698 · printed Nov 6, 2026
Cite this page
510(k) Report. “K182698: LIAISON Calprotectin, LIAISON Calprotectin Control Set, LIAISON Calprotectin Calibration Verifiers, LIAISON Q.S.E.T. Buffer, LIAISON Q.S.E.T. Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K182698
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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