Cleared Traditional

HemosIL Liquid Anti-Xa

K223187 · Instrumentation Laboratory CO · Hematology
Jun 2023
Decision
254d
Days
Class 2
Risk

About This 510(k) Submission

K223187 is an FDA 510(k) clearance for the HemosIL Liquid Anti-Xa, a Anti-factor Xa Activity Test System, Apixaban (Class II — Special Controls, product code QLU), submitted by Instrumentation Laboratory CO (Bedford, US). The FDA issued a Cleared decision on June 23, 2023, 254 days after receiving the submission on October 12, 2022. This device falls under the Hematology review panel. Regulated under 21 CFR 864.7295.

Submission Details

510(k) Number K223187 FDA.gov
FDA Decision Cleared SESE
Date Received October 12, 2022
Decision Date June 23, 2023
Days to Decision 254 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.