510(k) · Cleared
ClearedQUANTA Flash Calprotectin and Fecal Extraction Device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Inova Diagnostics, Inc. · NXO Calprotectin, Fecal
Cleared on Oct 16, 2018 as substantially equivalent to K170993 (Inova Diagnostics, Inc., 2017) after a 186-day review. Its family tree reaches back 4 generations to 2006.
- Decided
- Oct 16, 2018
- Review
- 186 days
- Class
- Class II
- Product code
- NXO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to DEN060001 (2006). No later device cites it as a predicate yet.
- Root · 4 generations backDEN060001 Phical TestGenova Diagnostics · 2006
- 3 generations backK130945 CalprestEurospital S.P.A. · 2014
- 2 generations backK160447 Calprest NGEurospital S.P.A. · 2016
- 1 generation backK170993 QUANTA Flash Calprotectin Reagents, QUANTA Flash Calprotectin…Inova Diagnostics, Inc. · 2017
- This deviceK180971 QUANTA Flash Calprotectin and Fecal Extraction DeviceInova Diagnostics, Inc. · 2018
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | DEN060001 | Phical Test | Genova Diagnostics | 2006 | — |
| −3 | K130945 | Calprest | Eurospital S.P.A. | 2014 | — |
| −2 | K160447 | Calprest NG | Eurospital S.P.A. | 2016 | — |
| −1 | K170993 | QUANTA Flash Calprotectin Reagents, QUANTA Flash Calprotectin Calibrators… | Inova Diagnostics, Inc. | 2017 | — |
| 0 (this device) | K180971 | QUANTA Flash Calprotectin and Fecal Extraction Device | Inova Diagnostics, Inc. | 2018 | — |
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? (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 |
|---|---|---|---|
| * | K170993 | QUANTA Flash Calprotectin Reagents, QUANTA Flash Calprotectin Calibrators, QUANTA Flash…Summary page 6…al Extraction Device Page 3 of 9 Predicate device QUANTA Flash Calprotectin (using manual extraction), 510(k) number: k170993. Date declared: December 22nd, 2017. Device description The Fecal Extraction Device acquires the amount of stool necessary to pe… | 2017 |
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 12 years and passes through 3 companies; a new generation was cleared every 2.8 years on median.
- None of the 4 ancestors has a recall.
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 Fecal Extraction Device is a single use tube containing extraction buffer intended for sampling and extracting human stool specimens and subsequent analysis with the QUANTA Flash Calprotectin assay.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K180971 · printed Nov 6, 2026
Cite this page
510(k) Report. “K180971: QUANTA Flash Calprotectin and Fecal Extraction Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K180971
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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