510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K240315Substantially Equivalent

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

Siemens Healthcare Diagnostics Products Limited, Marburg, DE / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K240315 is the FDA 510(k) clearance record for INNOVANCE Anti-Xa (OPPU05); INNOVANCE Apixaban Standards (OPPW05); INNOVANCE Apixaban Controls (OPPS05), a class II device, cleared for Siemens Healthcare Diagnostics Products GmbH on under FDA product code QLU (Anti-Factor Xa Activity Test System, Apixaban). FDA's definition for product code QLU reads: "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...". FDA records list 23 510(k) clearances for Siemens Healthcare Diagnostics Products GmbH, from to . As of , FDA records show no recalls naming K240315.

Clearance record

Decision date
Received
(251 days to decision)
Product code
QLU Anti-Factor Xa Activity Test System, Apixaban
Regulation
21 CFR 864.7295
Device class
Class II
Review panel
Hematology
Applicant
Siemens Healthcare Diagnostics Products GmbH Emil-Von-Behring-Strasse 76, Marburg, DE
510(k) summary
Summary PDF
Third party review
No

Clearances, product code QLU

Trailing 12 months

FDA records hold no clearances under product code QLU in the trailing twelve months.

FDA records show no clearances under product code QLU in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code QLU, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260