GKZ · Counter, Differential Cell

Hematology · 21 CFR 864.5220 · Class 2

Overview

Product CodeGKZ
Device NameCounter, Differential Cell
Regulation21 CFR 864.5220
Device ClassClass 2
Review PanelHematology

Identification

An automated differential cell counter is a device used to identify one or more of the formed elements of the blood. The device may also have the capability to flag, count, or classify immature or abnormal hematopoietic cells of the blood, bone marrow, or other body fluids. These devices may combine an electronic particle counting method, optical method, or a flow cytometric method utilizing monoclonal CD (cluster designation) markers. The device includes accessory CD markers.

Classification Rationale

Class II (special controls). The special control for this device is the FDA document entitled “Class II Special Controls Guidance Document: Premarket Notifications for Automated Differential Cell Counters for Immature or Abnormal Blood Cells; Final Guidance for Industry and FDA.”

Special Controls

*Classification.* Class II (special controls). The special control for this device is the FDA document entitled “Class II Special Controls Guidance Document: Premarket Notifications for Automated Differential Cell Counters for Immature or Abnormal Blood Cells; Final Guidance for Industry and FDA.”

Recent Cleared Devices (20 of 379)

Showing 20 most recent of 379 cleared devices.

RecordDevice NameApplicantDecision DateDecision
K243348Athelas HomeAthelas, Inc.Feb 6, 2026SESE
K251249Tru Hematology TestTruvian Sciences, Inc.Jan 16, 2026SESE
K251371Sysmex XR-Series (XR-20) Automated Hematology AnalyzerSysmex America, Inc.Jun 25, 2025SESE
K250943Sysmex XR-Series (XR-10) Automated Hematology AnalyzerSysmex America, Inc.Jun 25, 2025SESE
K243283Alinity h-series SystemAbbott LaboratoriesFeb 20, 2025SESE
K240402Cito CBC SystemCytochip, Inc.Feb 3, 2025SESE
K240252UniCel DxH 900 Coulter Cellular Analysis System; UniCel DxH Slidemaker Stainer II Coulter Cellular Analysis System; UniCel DxH 690T Coulter Cellular Analysis SystemBeckman Coulter, Inc.Jul 5, 2024SESE
K232946Yumizen H2500HORIBA ABX SASMay 21, 2024SESE
K240636HemoScreen Hematology AnalyzerPixcell Medical TechnologiesMay 2, 2024SESE
K230887Sysmex XQ-Series (XQ-320) Automated Hematology AnalyzerSysmex America, Inc.Dec 21, 2023SESE
K230878QScout Lab; QScout RLDAd Astra Diagnostics, Inc.Nov 14, 2023SESE
K222148HemoScreen Hematology AnalyzerPixcell Medical Technologies, Ltd.Aug 16, 2023SESE
K220031Alinity h-series SystemAbbott LaboratoriesAug 4, 2023SESE
K210346Sysmex XW-100 Automated Hematology AnalyzerSysmex America, Inc.Nov 8, 2022SESE
K211840Sight OLOS.D. Sight Diagnostics , Ltd.May 9, 2022SESE
K200828Athelas HomeAthelas, Inc.Mar 22, 2022SESE
K193124Unicel DxH 800 Coulter Cellular Analysis SystemBeckman CoulterApr 16, 2020SESE
K190898Sight OLOSight Diagnostics , Ltd.Nov 1, 2019SESE
K182886Cytomics FC 500 Series (MPL or MCL) Flow CytometerBeckman CoulterSep 6, 2019SESE
K190294CELL-DYN Emerald 22 AL SystemAbbott LaboratoriesMar 15, 2019SESE

Top Applicants

Innolitics

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