Cleared Traditional

HemoScreen Hematology Analyzer (K180020) - FDA 510(k) Clearance

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

K180020 · Pixcell Medical Technologies, Ltd. · Hematology device
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Oct 2018
Decision
300d
Days
Class 2
Risk

K180020 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. (Pob 113 Yoknaem Ilit, IL). The FDA issued a Cleared decision on October 29, 2018 after a review of 300 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. 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 Pixcell Medical Technologies, Ltd. devices

Submission Details

510(k) Number K180020 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 02, 2018
Decision Date October 29, 2018
Days to Decision 300 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
187d slower than avg
Panel avg: 113d · This submission: 300d
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

Erika B. Ammirati, Rac, MT (Ascp)
Erika B. 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 K180020.
DxH 520 Hematology Instrument
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K182389 · Sysmex America, Inc. · Jan 2019
Athelas One
K181288 · Athelas, Inc. · Nov 2018
cobas m 511 integrated hematology analyzer
K171655 · Roche Diagnostics Hematology, Inc. · Mar 2018
XW-100 Automated Hematology Analyzer for CLIA Waived Use
K172604 · Sysmex America, Inc. · Nov 2017
ADVIA 2120i, ADVIA 2120
K162977 · Siemens Healthcare Diagnostics · Aug 2017