510(k) · Cleared
Recalled · Class II · 2024LIAISON Calprotectin, LIAISON Q.S.E.T. Device Plus
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
DiaSorin, Inc. · NXO Calprotectin, Fecal
Cleared on Jul 26, 2022 as substantially equivalent to K182698 (DiaSorin, Inc., 2018) after a 228-day review. Its family tree reaches back 5 generations to 1995. It has been recalled once.
- Decided
- Jul 26, 2022
- Review
- 228 days
- Class
- Class II
- Product code
- NXO
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 5 generations to K954418 (1995). 9 ancestors in all. No later device cites it as a predicate yet.
- Root · 5 generations backK954418 Intact Parathyroid Hormone (PTH) Immunoassay (Modification)Nichols Institute Diagnostics · 1995
- 4 generations backK020217 Acs:180 and Advia Centaur Ipth ImmunoassayBayer Diagnostics Corp. · 2002 · Recalled
- 3 generations backK132515 Liaison N-Tact PTH Gen II, Control Set, Calibration VerifiersDiaSorin, Inc. · 2013
- 2 generations backK141463 Liason XL1,25 Dihydroxyvitamin D; Control Set, Calibration VerifiersDiaSorin, Inc. · 2014
- 1 generation backK182698 LIAISON Calprotectin, LIAISON Calprotectin Control Set, LIAISON…DiaSorin, Inc. · 2018
- This deviceK213858 LIAISON Calprotectin, LIAISON Q.S.E.T. Device PlusDiaSorin, Inc. · 2022
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K954418 | Intact Parathyroid Hormone (PTH) Immunoassay (Modification) | Nichols Institute Diagnostics | 1995 | — |
| −4 | K020217 | Acs:180 and Advia Centaur Ipth Immunoassay | Bayer Diagnostics Corp. | 2002 | 4 |
| −3 | K132515 | Liaison N-Tact PTH Gen II, Control Set, Calibration Verifiers | DiaSorin, Inc. | 2013 | — |
| −2 | K141463 | Liason XL1,25 Dihydroxyvitamin D; Control Set, Calibration Verifiers | DiaSorin, Inc. | 2014 | — |
| −1 | K182698 | LIAISON Calprotectin, LIAISON Calprotectin Control Set, LIAISON Calprotectin… | DiaSorin, Inc. | 2018 | — |
| 0 (this device) | K213858 | LIAISON Calprotectin, LIAISON Q.S.E.T. Device Plus | DiaSorin, Inc. | 2022 | — |
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 |
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
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 |
|---|---|---|---|
| * | K182698 | LIAISON Calprotectin, LIAISON Calprotectin Control Set, LIAISON Calprotectin Calibration…Summary page 4…NXO PREDICATE DEVICES : LIAISON® Calprotectin, LIAISON® Q.S.E.T. Device (K182698) DEVICE DESCRIPTION: INTENDED USE: The DiaSorin LIAISON® Calprotectin assay is an in vitro diagnostic chemiluminescent immunoas… | 2018 |
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 |
|---|---|---|---|---|
| Nov 7, 2024 | Class II | Z-0677-2025 | Process control | Customer complaints were received alleging leaking devices and insufficient buffer volume. Diasorin's internal investigation determined that 0.14% of the LIAISON Q.S.E.T. Device Plus in the lots identified have loose clear caps, which may… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 27 years and passes through 3 companies; a new generation was cleared every 4.0 years on median.
- 2 of the 9 ancestors have a recall of any class.
How does its category compare?
All NXO devicesNXO Calprotectin, Fecal: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, 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 (131 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® Analyzer Family.
The DiaSorin LIAISON® Q.S.E.T. Device Plus (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/K213858 · printed Nov 6, 2026
Cite this page
510(k) Report. “K213858: LIAISON Calprotectin, LIAISON Q.S.E.T. Device Plus.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K213858
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