510(k) · Hematology

X100 with Full Field Peripheral Blood Smear (PBS) Application

by Scopio Labs LTD.

X100 with Full Field Peripheral Blood Smear (PBS) Application is an AI-enabled medical device from Scopio Labs LTD. that the U.S. FDA cleared through 510(k) K201301 on October 2, 2020. Its lead review panel is Hematology and its primary product code is JOY (Device, Automated Cell-Locating).

See also all FDA AI clearances in 2020, top hematology AI devices.

Key facts

Submission numberK201301
Pathway510(k)
Date of final decision
Company (FDA list)Scopio Labs LTD.
Lead review panelHematology
Primary product codeJOY — Device, Automated Cell-Locating
Applicant (openFDA)Scopio Labs , Ltd.
Applicant locationTel Aviv, IL
Device classClass 2
Regulation number21 CFR 864.5260
Decision codeSESE
Submission typeTraditional

Source: FDA AI-Enabled Medical Devices list and openFDA.

What this means

A 510(k) is a premarket submission showing the device is substantially equivalent to a legally marketed predicate device. A cleared 510(k) means FDA agreed with that equivalence. X100 with Full Field Peripheral Blood Smear (PBS) Application went through this pathway (K201301).

openFDA lists it as a Class 2 device under 21 CFR 864.5260. Class II devices are moderate risk and are subject to general and special controls.

Product code JOY covers 11 devices on the FDA AI list. By decision date, this device is #7 of 11 under that code. Scopio Labs LTD. has 3 AI-enabled devices on the list, and the Hematology panel accounts for 22 in total.

Being on this list doesn't describe how well the device works clinically. Check the FDA record for its indications for use.

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