FDA product code NXO: Calprotectin, Fecal
NXO is the FDA product code for calprotectin, fecal. It is a Class II device, regulated under 21 CFR 866.5180 and reviewed by the Immunology panel. FDA has cleared 14 510(k) submissions under NXO, 3 in the last five years, from 6 different applicants. The average 510(k) review took 165 days (median 149); 210 days on average over the last three years. 1 De Novo request was granted under it. FDA has posted 3 recalls for NXO devices, 3 initiated in the last five years.
Definition
The device is used for the measurement, in human stool, of fecal calprotectin, a neutrophilic protein that is a marker of mucosal inflammation. The device can be used as an aid in the diagnosis of inflammatory bowel disease (ibd), crohn's disease and ulcerative colitis and to differentiate ibd from irritable bowel syndrome.
Classification
| Field | Value |
|---|---|
| Device name | Calprotectin, Fecal |
| Device class | Class II |
| Regulation | 21 CFR 866.5180 |
| Review panel | IM — Immunology |
| Medical specialty | Immunology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for NXO
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 1 | 263 |
| 2018 | 3 | 108 |
| 2019 | 5 | 69 |
| 2022 | 1 | 228 |
| 2023 | 1 | 393 |
| 2024 | 1 | 210 |
Compare with all 510(k) review times · Search every NXO clearance
Top NXO applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Eurospital S.P.A. | 4 | 2019-07-10 |
| Buhlmann Laboratories AG | 3 | 2019-09-24 |
| ALPCO | 2 | 2023-04-13 |
| DiaSorin, Inc. | 2 | 2022-07-26 |
| Inova Diagnostics, Inc. | 2 | 2018-10-16 |
1 more applicants have NXO clearances. See the full list in Caduvo.
Most recent NXO clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K232057 | Bühlmann Laboratories AG | BÜHLMANN fCAL® turbo and CALEX® Cap | 2024-02-06 | 210 |
| K220763 | ALPCO | ALPCO Calprotectin Immunoturbidimetric Assay | 2023-04-13 | 393 |
| K213858 | DiaSorin, Inc. | LIAISON Calprotectin, LIAISON Q.S.E.T. Device Plus | 2022-07-26 | 228 |
| K191807 | ALPCO | ALPCO Calprotectin Chemiluminescence ELISA, ALPCO Easy Stool Extraction Device | 2019-10-25 | 112 |
| K191718 | Buhlmann Laboratories AG | Buhlmann fCAL turbo and CALEX Cap | 2019-09-24 | 90 |
Recalls for NXO devices
3 product recalls in 2 recall events; 3 initiated in the last five years and 3 still open. Most recent: 2025-11-03.
| Year | Recalls |
|---|---|
| 2024 | 1 |
| 2025 | 2 |
Frequently asked questions
What is FDA product code NXO?
NXO is the FDA product code for calprotectin, fecal. It is a Class II device, regulated under 21 CFR 866.5180 and reviewed by the Immunology panel.
What device class is NXO?
Class II, regulation 21 CFR 866.5180. Typical premarket route: 510(k).
How long does a 510(k) take for product code NXO?
Across 14 cleared submissions the average was 165 days from receipt to decision (median 149).
Which companies have the most NXO clearances?
Eurospital S.P.A. (4); Buhlmann Laboratories AG (3); ALPCO (2); DiaSorin, Inc. (2); Inova Diagnostics, Inc. (2).
Have NXO devices been recalled?
Yes: 3 product recalls across 2 recall events; the most recent began 2025-11-03.
Next steps
- Run an FDA pathway report with predicate devices for product code NXO
- Run a recall and safety report across every NXO manufacturer
- Watch product code NXO for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
All Immunology product codes · FDA product code lookup · 510(k) database search · 510(k) review times