510(k) · Cleared
ClearedHemosIL 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
Cleared on Jun 23, 2023 as substantially equivalent to DEN190032 (Instrumentation Laboratory CO, 2020) and 1 other predicate after a 254-day review. Its family tree reaches back 4 generations to 1994. 1 later device descends from it.
- Decided
- Jun 23, 2023
- Review
- 254 days
- Class
- Class II
- Product code
- QLU
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K935212 (1994). 8 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 4 generations backK935212 IL Test Heparin (XA), PN 84699-15Instrumentation Laboratory CO · 1994
- 3 generations backK980242 IL Test HeparinInstrumentation Laboratory CO · 1998 · Recalled
- 2 generations backK090209 Hemosil Liquid Heparin, Heparin Calibrators and LMW and UF Heparin…Instrumentation Laboratory CO · 2009 · Recalled
- 1 generation backK213464 HemosIL Liquid Anti-XaInstrumentation Laboratory CO · 2022 · Recalled
- This deviceK223187 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 1 of 1 · See all- 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 |
|---|---|---|---|---|---|
| −4 | K935212 | IL Test Heparin (XA), PN 84699-15 | Instrumentation Laboratory CO | 1994 | — |
| −3 | K980242 | IL Test Heparin | Instrumentation Laboratory CO | 1998 | 1 |
| −2 | K090209 | Hemosil Liquid Heparin, Heparin Calibrators and LMW and UF Heparin Controls | Instrumentation Laboratory CO | 2009 | 5 |
| −1 | K213464 | HemosIL Liquid Anti-Xa | Instrumentation Laboratory CO | 2022 | 2 |
| 0 (this device) | 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 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2003 | 2 | 0 |
| 2020 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 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 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 K240315 INNOVANCE Anti-Xa (OPPU05); INNOVANCE Apixaban…score 9.4 · 5 generations · no Class I recall
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | DEN190032 | HemosIL Liquid Anti-XaSummary page 5…II Information Product Code QLU Classification Panel Hematology (81) DEN190032 Predicate Device Nos. Predicate Device Name HemosIL Liquid Anti-Xa… | 2020 |
| * | K213464 | HemosIL Liquid Anti-XaSummary page 5…(81) DEN190032 Predicate Device Nos. Predicate Device Name HemosIL Liquid Anti-Xa K213464 HemosIL Liquid Anti-Xa is a one stage chromogenic assay based on a synthetic chr… | 2022 |
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 |
|---|---|---|---|
| K240315 | INNOVANCE Anti-Xa (OPPU05); INNOVANCE Apixaban Standards (OPPW05); INNOVANCE Apixaban… | 2024 | 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 29 years and passes through 1 company; a new generation was cleared every 11.2 years on median.
- 4 of the 8 ancestors have a recall of any class.
- Of its descendants, K240315 (Siemens Healthcare Diagnostics Products GmbH, 2024) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate DEN190032.
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. 2023, 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 and ACL TOP…
Read the full statement (265 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 and ACL TOP Family 50 Series.
• 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
• When used with HemosIL Rivaroxaban Calibrators:
Quantitative determination of rivaroxaban on the ACL TOP Family and ACL TOP Family 50 Series through measurement of factor Xa activity, which is inversely proportional to the rivaroxaban level. With HemosIL Rivaroxaban Calibrators, the assay is intended to measure rivaroxaban concentrations in patients on rivaroxaban therapy in the following situations where measurement of rivaroxaban 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/K223187 · printed Nov 4, 2026
Cite this page
510(k) Report. “K223187: HemosIL Liquid Anti-Xa.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K223187
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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