Cleared Traditional

INNOVANCE Anti-Xa (OPPU05); INNOVANCE Apixaban Standards (OPPW05); INNOVANCE Apixaban Controls (OPPS05)

K240315 · Siemens Healthcare Diagnostics Products GmbH · Hematology

Oct 2024

Decision

251d

Days

Class 2

Risk

About This 510(k) Submission

K240315 is an FDA 510(k) clearance for the INNOVANCE Anti-Xa (OPPU05); INNOVANCE Apixaban Standards (OPPW05); INNOVANCE Apixaban Controls (OPPS05), a Anti-factor Xa Activity Test System, Apixaban (Class II — Special Controls, product code QLU), submitted by Siemens Healthcare Diagnostics Products GmbH (Marburg, DE). The FDA issued a Cleared decision on October 10, 2024, 251 days after receiving the submission on February 2, 2024. This device falls under the Hematology review panel. Regulated under 21 CFR 864.7295.

Submission Details

510(k) Number	K240315 FDA.gov
FDA Decision	Cleared 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

Device Classification

Product Code	QLU — Anti-factor Xa Activity Test System, Apixaban
Device Class	Class II — 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.