INNOVANCE Anti-Xa (OPPU05); INNOVANCE Apixaban Standards (OPPW05); INNOVANCE Apixaban Controls (OPPS05)
FDA 510(k) K240315 · Siemens Healthcare Diagnostics Products GmbH
Submission
- Device name
- INNOVANCE Anti-Xa (OPPU05); INNOVANCE Apixaban Standards (OPPW05); INNOVANCE Apixaban Controls (OPPS05)
- Applicant
- Siemens Healthcare Diagnostics Products GmbH
Marburg, DE - Received
- February 2, 2024
- Decision date
- October 10, 2024
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- QLU – Anti-Factor Xa Activity Test System, Apixaban
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 864.7295
- Specialty
- Hematology
A heparin and direct oral factor Xa inhibitor drug test system is intended for the detection of heparin and direct oral factor Xa inhibitors in human specimens collected from patients taking heparin or direct oral factor Xa inhibitors. This device is intended to aid in the management of therapy in conjunction with other clinical and laboratory findings.
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|---|---|---|---|
| K223187 | HemosIL Liquid Anti-XaQLU · Traditional | Instrumentation Laboratory CO | 06/23/2023SE |
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Questions and answers
When was INNOVANCE Anti-Xa (OPPU05); INNOVANCE Apixaban Standards (OPPW05); INNOVANCE Apixaban Controls (OPPS05) cleared by the FDA?
INNOVANCE Anti-Xa (OPPU05); INNOVANCE Apixaban Standards (OPPW05); INNOVANCE Apixaban Controls (OPPS05) (K240315) received a 510(k) decision of Substantially Equivalent on October 10, 2024, 251 days after the submission was received.
What is the product code of K240315?
The FDA product code is QLU – Anti-Factor Xa Activity Test System, Apixaban, a Class II (moderate risk) device regulated under 21 CFR 864.7295.