Not Cleared Direct

DEN190032 - HemosIL Liquid Anti-Xa (FDA 510(k) Clearance)

Class II Hematology device cleared through the Direct 510(k) pathway - typically does not require clinical trials.

DEN190032 · Instrumentation Laboratory CO · Hematology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2020
Decision
450d
Days
Class 2
Risk

DEN190032 is an FDA 510(k) submission (not cleared) for the HemosIL Liquid Anti-Xa. Classified as Anti-factor Xa Activity Test System, Apixaban (product code QLU), Class II - Special Controls.

Submitted by Instrumentation Laboratory CO (Bedford, US). The FDA issued a Not Cleared (DENG) decision on September 17, 2020 after a review of 450 days.

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 requires demonstration of substantial equivalence to a legally marketed predicate device - a standard the FDA determined was not met in this submission.

Device pattern: Regulatory edge-case submission. High predicate equivalence gap. With 450 days under review and no clearance granted, this submission reflects a case where the FDA could not confirm sufficient predicate equivalence - often indicating either a novel device category or unresolved safety and performance questions.

View all Instrumentation Laboratory CO devices

Submission Details

510(k) Number DEN190032 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received June 25, 2019
Decision Date September 17, 2020
Days to Decision 450 days
Submission Type Direct
Review Panel Hematology (HE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
337d slower than avg
Panel avg: 113d · This submission: 450d
Pathway characteristics

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.