Not Cleared Direct

DEN230034 - X100 with Full Field Bone Marrow Aspirate (BMA) Application 2 X100HT with Full Field Bone Marrow Aspirate (BMA) Application (FDA 510(k) Clearance)

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

DEN230034 · Scopio Labs , Ltd. · Hematology device
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Mar 2024
Decision
329d
Days
Class 2
Risk

DEN230034 is an FDA 510(k) submission (not cleared) for the X100 with Full Field Bone Marrow Aspirate (BMA) Application 2 X100HT with Ful.... Classified as Device, Automated Cell Locating, Bone Marrow (product code SAL), Class II - Special Controls.

Submitted by Scopio Labs , Ltd. (Tel-Aviv, IL). The FDA issued a Not Cleared (DENG) decision on March 22, 2024 after a review of 329 days.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.5261 - 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 329 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.

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Submission Details

510(k) Number DEN230034 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received April 28, 2023
Decision Date March 22, 2024
Days to Decision 329 days
Submission Type Direct
Review Panel Hematology (HE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
216d slower than avg
Panel avg: 113d · This submission: 329d
Pathway characteristics

Device Classification

Product Code SAL Device, Automated Cell Locating, Bone Marrow
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.5261
Definition An Automated Cell-locating Device For Bone Marrow Aspirate Is An In Vitro Diagnostic Device Intended For Prescription Use That Automatically Locates And Presents Images Of Hematopoietic Cells On A Bone Marrow Aspirate Smear Obtained From Patients Being Evaluated For Hematologic Diseases. The Device Assists Operators To Identify And Classify Each Cell According To Type.
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.