Cleared Traditional

K240315 - INNOVANCE Anti-Xa (OPPU05) (FDA 510(k) Clearance)

Also includes:
INNOVANCE Apixaban Standards (OPPW05) INNOVANCE Apixaban Controls (OPPS05)

Class II Hematology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K240315 · Siemens Healthcare Diagnostics Products GmbH · Hematology device
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Oct 2024
Decision
251d
Days
Class 2
Risk

K240315 is an FDA 510(k) clearance for the INNOVANCE Anti-Xa (OPPU05). Classified as Anti-factor Xa Activity Test System, Apixaban (product code QLU), Class II - Special Controls.

Submitted by Siemens Healthcare Diagnostics Products GmbH (Marburg, DE). The FDA issued a Cleared decision on October 10, 2024 after a review of 251 days - an extended review cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.7295 - the FDA hematology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Hematology review framework, consistent with the majority of Class II 510(k) submissions.

View all Siemens Healthcare Diagnostics Products GmbH devices

Submission Details

510(k) Number K240315 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 02, 2024
Decision Date October 10, 2024
Days to Decision 251 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
138d slower than avg
Panel avg: 113d · This submission: 251d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code QLU Anti-factor Xa Activity Test System, Apixaban
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.7295
Definition 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.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Hematology devices follow this clearance model.