Cleared Traditional

K220013 - X100HT with Slide Loader with Full Field Peripheral Blood Smear (PBS) Application (FDA 510(k) Clearance)

Class II Hematology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K220013 · Scopio Labs , Ltd. · Hematology device
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May 2022
Decision
119d
Days
Class 2
Risk

K220013 is an FDA 510(k) clearance for the X100HT with Slide Loader with Full Field Peripheral Blood Smear (PBS) Applica.... Classified as Device, Automated Cell-locating (product code JOY), Class II - Special Controls.

Submitted by Scopio Labs , Ltd. (Tel Aviv, IL). The FDA issued a Cleared decision on May 3, 2022 after a review of 119 days - within the typical 510(k) review window.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.5260 - the FDA hematology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Hematology review framework, consistent with the majority of Class II 510(k) submissions.

View all Scopio Labs , Ltd. devices

Submission Details

510(k) Number K220013 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 04, 2022
Decision Date May 03, 2022
Days to Decision 119 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
6d slower than avg
Panel avg: 113d · This submission: 119d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JOY Device, Automated Cell-locating
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.5260
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.

Regulatory Consultant

Hogan Lovells US LLP
Randy J. Prebula

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.