510(k) · Cleared
ClearedINNOVANCE Anti-Xa (OPPU05); INNOVANCE Apixaban Standards (OPPW05); INNOVANCE Apixaban Controls (OPPS05)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Siemens Healthcare Diagnostics Products GmbH · QLU Anti-Factor Xa Activity Test System, Apixaban
Cleared on Oct 10, 2024 as substantially equivalent to DEN190032 (Instrumentation Laboratory CO, 2020) and 2 other predicates after a 251-day review. Its family tree reaches back 5 generations to 1994.
- Decided
- Oct 10, 2024
- Review
- 251 days
- Class
- Class II
- Product code
- QLU
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 5 generations to K935212 (1994). 9 ancestors in all. No later device cites it as a predicate yet.
- Root · 5 generations backK935212 IL Test Heparin (XA), PN 84699-15Instrumentation Laboratory CO · 1994
- 4 generations backK980242 IL Test HeparinInstrumentation Laboratory CO · 1998 · Recalled
- 3 generations backK090209 Hemosil Liquid Heparin, Heparin Calibrators and LMW and UF Heparin…Instrumentation Laboratory CO · 2009 · Recalled
- 2 generations backK213464 HemosIL Liquid Anti-XaInstrumentation Laboratory CO · 2022 · Recalled
- 1 generation backK223187 HemosIL Liquid Anti-XaInstrumentation Laboratory CO · 2023
- This deviceK240315 INNOVANCE Anti-Xa (OPPU05); INNOVANCE Apixaban Standards (OPPW05)…Siemens Healthcare Diagnostics Products GmbH · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K935212 | IL Test Heparin (XA), PN 84699-15 | Instrumentation Laboratory CO | 1994 | — |
| −4 | K980242 | IL Test Heparin | Instrumentation Laboratory CO | 1998 | 1 |
| −3 | K090209 | Hemosil Liquid Heparin, Heparin Calibrators and LMW and UF Heparin Controls | Instrumentation Laboratory CO | 2009 | 5 |
| −2 | K213464 | HemosIL Liquid Anti-Xa | Instrumentation Laboratory CO | 2022 | 2 |
| −1 | K223187 | HemosIL Liquid Anti-Xa | Instrumentation Laboratory CO | 2023 | — |
| 0 (this device) | 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 |
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 K223187 HemosIL Liquid Anti-Xascore 9.5 · 4 generations · no Class I recall
What was it cleared against? (3)
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…xaban Regulatory Class: Class II 510(k) Review Panel Hematology (81) 3. Predicate Device Name of Device / 510(k): HemosIL Liquid Anti-Xa / DEN190032, K213464, K223187 Regulation Number: 21 CFR 864.7295 Regulation Description: Heparin And Direct Oral Factor Xa Inh… | 2020 |
| * | K213464 | HemosIL Liquid Anti-XaSummary page 5…atory Class: Class II 510(k) Review Panel Hematology (81) 3. Predicate Device Name of Device / 510(k): HemosIL Liquid Anti-Xa / DEN190032, K213464, K223187 Regulation Number: 21 CFR 864.7295 Regulation Description: Heparin And Direct Oral Factor Xa Inhibitor Dr… | 2022 |
| * | K223187 | HemosIL Liquid Anti-XaSummary page 5…ss: Class II 510(k) Review Panel Hematology (81) 3. Predicate Device Name of Device / 510(k): HemosIL Liquid Anti-Xa / DEN190032, K213464, K223187 Regulation Number: 21 CFR 864.7295 Regulation Description: Heparin And Direct Oral Factor Xa Inhibitor Drug Test S… | 2023 |
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 30 years and passes through 2 companies; a new generation was cleared every 4.1 years on median.
- 4 of the 9 ancestors have a recall of any class.
- 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. 2024, 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?
INNOVANCE Anti-Xa assay in combination with INNOVANCE Heparin Calibrator is an In-vitro diagnostic automated chromogenic assay for the quantitative determination of unfractionated heparin (UFH) and low molecular weight heparin (LMWH) activity in human plasma collected from venous blood samples in 3.2 % sodium citrated tubes in the clinical laboratory. The quantitative determination of UFH and LMWH can be performed on the BCS XP System, CS-2500 System…
Read the full statement (206 words)
INNOVANCE Anti-Xa assay in combination with INNOVANCE Heparin Calibrator is an In-vitro diagnostic automated chromogenic assay for the quantitative determination of unfractionated heparin (UFH) and low molecular weight heparin (LMWH) activity in human plasma collected from venous blood samples in 3.2 % sodium citrated tubes in the clinical laboratory. The quantitative determination of UFH and LMWH can be performed on the BCS XP System, CS-2500 System, CS-5100 System and the CA‑660 System. For use with plasma from patients undergoing anticoagulant therapy with either UFH or LMWH.
INNOVANCE Anti-Xa assay in combination with INNOVANCE Apixaban Standard provides quantitative determination of the concentration of apixaban in human plasma collected from venous blood samples in 3.2 % sodium citrated tubes in the clinical laboratory. The quantitative determination of apixaban can be performed on CS-2500 System. For use with plasma from patients undergoing anticoagulant therapy with apixaban in situations where quantification of apixaban levels may be indicated:
• Patient with bleeding,
• Patient with risk for bleeding (e.g. during perioperative management),
• Patient with conditions affecting pharmacokinetics (e.g. deteriorating renal function, extremes of body weight, treatment with other drugs known to affect pharmacokinetics of apixaban).
The performance of this device has not been established in neonate and pediatric patient populations.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K240315 · printed Nov 6, 2026
Cite this page
510(k) Report. “K240315: INNOVANCE Anti-Xa (OPPU05); INNOVANCE Apixaban Standards (OPPW05); INNOVANCE Apixaban Controls (OPPS05).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K240315
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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