510(k) · Cleared
ClearedQUANTA Flash Calprotectin Reagents, QUANTA Flash Calprotectin Calibrators, QUANTA Flash Calprotectin Controls, QUANTA Flash Calprotectin Extraction Buffer
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 Dec 22, 2017 as substantially equivalent to K160447 (Eurospital S.P.A., 2016) after a 263-day review. Its family tree reaches back 3 generations to 2006. 1 later device descends from it.
- Decided
- Dec 22, 2017
- Review
- 263 days
- Class
- Class II
- Product code
- NXO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to DEN060001 (2006). 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backDEN060001 Phical TestGenova Diagnostics · 2006
- 2 generations backK130945 CalprestEurospital S.P.A. · 2014
- 1 generation backK160447 Calprest NGEurospital S.P.A. · 2016
- This deviceK170993 QUANTA Flash Calprotectin Reagents, QUANTA Flash Calprotectin…Inova Diagnostics, Inc. · 2017
- Descendant · cites it directly · 0 of its ownK180971 QUANTA Flash Calprotectin and Fecal Extraction DeviceInova Diagnostics, Inc. · 2018
Most influential descendants
Showing 1 of 1 · See all- K180971QUANTA Flash Calprotectin and Fecal Extraction DeviceInova Diagnostics, Inc. · 2018 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | DEN060001 | Phical Test | Genova Diagnostics | 2006 | — |
| −2 | K130945 | Calprest | Eurospital S.P.A. | 2014 | — |
| −1 | K160447 | Calprest NG | Eurospital S.P.A. | 2016 | — |
| 0 (this device) | K170993 | QUANTA Flash Calprotectin Reagents, QUANTA Flash Calprotectin Calibrators… | Inova Diagnostics, Inc. | 2017 | — |
| +1 | K180971 | QUANTA Flash Calprotectin and Fecal Extraction Device | Inova Diagnostics, Inc. | 2018 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 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? (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 |
|---|---|---|---|
| * | K160447 | Calprest NGSummary page 7…Calprotectin Page 4 of 23 Predicate device Calprest NG (QUANTA Lite® Calprotectin Extended Range ELISA), 510(k) number: k160447. Date declared: November 10, 2016. Device description The principle of the assay is chemiluminescent microparticle immunoassay,… | 2016 |
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 |
|---|---|---|---|
| K180971 | QUANTA Flash Calprotectin and Fecal Extraction Device | 2018 | 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 11 years and passes through 3 companies; a new generation was cleared every 2.8 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K180971 (Inova Diagnostics, Inc., 2018) has gone furthest, with 0 descendants of its own.
- 3 other devices also cite its predicate K160447.
How does its category compare?
All NXO devicesNXO Calprotectin, Fecal: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, 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?
QUANTA Flash Calprotectin is a chemiluminescent immunoassay for the quantitative determination of fecal calprotectin in extracted human stool samples. Elevated levels of fecal calprotectin, in conjunction with clinical findings and other laboratory tests, can aid in the diagnosis of inflammatory bowel disease (IBD) (ulcerative colitis and Crohn’s disease), and in the differentiation of IBD from irritable bowel syndrome (IBS). QUANTA Flash Calprotectin…
Read the full statement (130 words)
QUANTA Flash Calprotectin is a chemiluminescent immunoassay for the quantitative determination of fecal calprotectin in extracted human stool samples. Elevated levels of fecal calprotectin, in conjunction with clinical findings and other laboratory tests, can aid in the diagnosis of inflammatory bowel disease (IBD) (ulcerative colitis and Crohn’s disease), and in the differentiation of IBD from irritable bowel syndrome (IBS).
QUANTA Flash Calprotectin Calibrators are intended for use with the QUANTA Flash Calprotectin Reagents for the determination of fecal calprotectin levels in extracted stool samples. Each calibrator establishes a point of reference for the working curve that is used to calculate unit values.
QUANTA Flash Calprotectin Controls are intended for use with the QUANTA Flash Calprotectin Reagents for quality control in the determination of fecal calprotectin levels in extracted stool samples.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K170993 · printed Nov 6, 2026
Cite this page
510(k) Report. “K170993: QUANTA Flash Calprotectin Reagents, QUANTA Flash Calprotectin Calibrators, QUANTA Flash Calprotectin Controls, QUANTA Flash Calprotectin Extraction Buffer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K170993
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