Cleared Traditional

HemoScreen Hematology Analyzer (K222148) - FDA 510(k) Clearance

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

K222148 · Pixcell Medical Technologies, Ltd. · Hematology device
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Aug 2023
Decision
392d
Days
Class 2
Risk

K222148 is an FDA 510(k) clearance for the HemoScreen Hematology Analyzer. Classified as Counter, Differential Cell (product code GKZ), Class II - Special Controls.

Submitted by Pixcell Medical Technologies, Ltd. (Yoknaem Ilit, IL). The FDA issued a Cleared decision on August 16, 2023 after a review of 392 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.5220 - 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. Elevated predicate reliance profile. 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 Pixcell Medical Technologies, Ltd. devices

Submission Details

510(k) Number K222148 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 20, 2022
Decision Date August 16, 2023
Days to Decision 392 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
279d slower than avg
Panel avg: 113d · This submission: 392d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GKZ Counter, Differential Cell
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.5220
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

Ammirati Regulatory Consulting
Erika Ammirati

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.

Regulatory Peers - GKZ Counter, Differential Cell

All 126
Devices cleared under the same product code (GKZ) and FDA review panel - the closest regulatory comparables to K222148.
HemoScreen Hematology Analyzer
K240636 · Pixcell Medical Technologies · May 2024
Sysmex XQ-Series (XQ-320) Automated Hematology Analyzer
K230887 · Sysmex America, Inc. · Dec 2023
QScout Lab
K230878 · Ad Astra Diagnostics, Inc. · Nov 2023
Alinity h-series System
K220031 · Abbott Laboratories · Aug 2023
Sysmex XW-100 Automated Hematology Analyzer
K210346 · Sysmex America, Inc. · Nov 2022
Sight OLO
K211840 · S.D. Sight Diagnostics , Ltd. · May 2022