De Novo · Granted
GrantedHemosIL Liquid Anti-Xa
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Instrumentation Laboratory CO · QLU Anti-Factor Xa Activity Test System, Apixaban
Granted on Sep 17, 2020 as a new device type through De Novo after a 450-day review. 3 later devices descend from it.
- Decided
- Sep 17, 2020
- Review
- 450 days
- Class
- Class II
- Product code
- QLU
- Recalls
- None
3 later devices descend from it, 3 citing it directly.
- This deviceDEN190032 HemosIL Liquid Anti-XaInstrumentation Laboratory CO · 2020
- Descendant · cites it directly · 2 of its ownK213464 HemosIL Liquid Anti-XaInstrumentation Laboratory CO · 2022 · Recalled
- Descendant · cites it directly · 1 of its ownK223187 HemosIL Liquid Anti-XaInstrumentation Laboratory CO · 2023
- Descendant · cites it directly · 0 of its ownK240315 INNOVANCE Anti-Xa (OPPU05); INNOVANCE Apixaban Standards (OPPW05)…Siemens Healthcare Diagnostics Products GmbH · 2024
Most influential descendants
Showing 3 of 3 · See all- K213464HemosIL Liquid Anti-XaInstrumentation Laboratory CO · 2022 · cites it directly2descendants
- K223187HemosIL Liquid Anti-XaInstrumentation Laboratory CO · 2023 · cites it directly1descendant
- K240315INNOVANCE Anti-Xa (OPPU05); INNOVANCE Apixaban Standards (OPPW05); INNOVANCE Apixaban…Siemens Healthcare Diagnostics Products GmbH · 2024 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | DEN190032 | HemosIL Liquid Anti-Xa | Instrumentation Laboratory CO | 2020 | — |
| +1 | K213464 | HemosIL Liquid Anti-Xa | Instrumentation Laboratory CO | 2022 | 2 |
| +1 | K223187 | HemosIL Liquid Anti-Xa | Instrumentation Laboratory CO | 2023 | — |
| +1 | K240315 | INNOVANCE Anti-Xa (OPPU05); INNOVANCE Apixaban Standards (OPPW05); INNOVANCE… | Siemens Healthcare Diagnostics Products GmbH | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
Sources: FDA De Novo 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 QLU? 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 QLU device
- #1 K223187 HemosIL Liquid Anti-Xascore 9.5 · 4 generations · no Class I recall
- #2 Held for the reportin the report
Does it have a predicate?
De Novo decisions do not claim a predicate device.
What descends from it? (3)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- Of its descendants, K213464 (Instrumentation Laboratory CO, 2022) has gone furthest, with 2 descendants of its own.
How does its category compare?
All QLU devicesQLU Anti-Factor Xa Activity Test System, Apixaban: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, this device’s year, is highlighted.
FDA decisions per year · QLU
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · QLU
Too few QLU 510(k)s in any year since 2007 to give a median.
Recalls per year · QLU
1in 2021
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · QLU
No MAUDE report names QLU since 2007.
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 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 1 | — | 0 | 0 |
| 2021 | 0 | — | 1 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 1 | — | 0 | 0 |
| 2024 | 1 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
HemosIL Liquid Anti-Xa is an automated chromogenic assay for in vitro diagnostic use by laboratory professionals in clinical laboratories. The assay provides quantitative results on 3.2% citrated human plasma for the following analytes based on the calibrators used: • When used with HemosIL Heparin Calibrators: Quantitative determination of unfractionated heparin (UFH) and low molecular weight heparin (LMWH) activity on the ACL TOP Family, ACL TOP Family…
Read the full statement (185 words)
HemosIL Liquid Anti-Xa is an automated chromogenic assay for in vitro diagnostic use by laboratory professionals in clinical laboratories. The assay provides quantitative results on 3.2% citrated human plasma for the following analytes based on the calibrators used:
• When used with HemosIL Heparin Calibrators:
Quantitative determination of unfractionated heparin (UFH) and low molecular weight heparin (LMWH) activity on the ACL TOP Family, ACL TOP Family 50 Series, and ACL Elite/Elite Pro.
• When used with HemosIL Apixaban Calibrators:
Quantitative determination of apixaban on the ACL TOP Family and ACL TOP Family 50 Series through measurement of Factor Xa activity, which is inversely proportional to the apixaban level. With HemosIL Apixaban Calibrators, the assay is intended to measure apixaban concentrations in patients on apixaban therapy in the following situations where measurement of apixaban levels could be useful to have as additional information:
- Patients at risk for major bleeding
- Patients experiencing a bleeding episode
The assay is not a stand-alone test and the results should be used in conjunction with other clinical and laboratory findings.
For use in adult population. For prescription use only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/DEN190032 · printed Nov 3, 2026
Cite this page
510(k) Report. “DEN190032: HemosIL Liquid Anti-Xa.” Lineage record from FDA De Novo data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/DEN190032
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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