Cleared Traditional

X100 with Full Field Peripheral Blood Smear (PBS) Application

K201301 · Scopio Labs , Ltd. · Hematology
Oct 2020
Decision
140d
Days
Class 2
Risk

About This 510(k) Submission

K201301 is an FDA 510(k) clearance for the X100 with Full Field Peripheral Blood Smear (PBS) Application, a Device, Automated Cell-locating (Class II — Special Controls, product code JOY), submitted by Scopio Labs , Ltd. (Tel Aviv, IL). The FDA issued a Cleared decision on October 2, 2020, 140 days after receiving the submission on May 15, 2020. This device falls under the Hematology review panel. Regulated under 21 CFR 864.5260.

Submission Details

510(k) Number K201301 FDA.gov
FDA Decision Cleared SESE
Date Received May 15, 2020
Decision Date October 02, 2020
Days to Decision 140 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Summary PDF

Device Classification

Product Code JOY — Device, Automated Cell-locating
Device Class Class II — Special Controls
CFR Regulation 21 CFR 864.5260

Similar Devices — JOY Device, Automated Cell-locating

All 34
X100/X100HT with Full Field Peripheral Blood Smear (PBS) Application
K243144 · Scopio Labs , Ltd. · Jun 2025
AI100 with Shonit
K221309 · Sigtuple Technologies Pvt. , Ltd. · Sep 2023
X100HT with Slide Loader with Full Field Peripheral Blood Smear (PBS) Application
K220013 · Scopio Labs , Ltd. · May 2022
CellaVision DC-1, CellaVision DC-1 PPA
K200595 · CellaVision AB · Oct 2020
Sysmex UD-10, Fully Automated Urine Particle Digital Imaging Device
K182062 · Sysmex America, Inc. · Oct 2018
Advanced RBC Application
K171315 · CellaVision AB · Aug 2017