Browse hierarchy: [Hematology (HE)](/submissions/HE) → [Subpart F — Automated and Semi-Automated Hematology Devices](/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices) → [21 CFR 864.5220](/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/864.5220) → GKZ — Counter, Differential Cell # GKZ · Counter, Differential Cell _Hematology · 21 CFR 864.5220 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/GKZ ## Overview - **Product Code:** GKZ - **Device Name:** Counter, Differential Cell - **Regulation:** [21 CFR 864.5220](/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/864.5220) - **Device Class:** 2 - **Review Panel:** [Hematology](/submissions/HE) ## 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. | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K243348](https://fda.innolitics.com/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/GKZ/K243348.md) | Athelas Home | Athelas, Inc. | Feb 6, 2026 | SESE | | [K251249](https://fda.innolitics.com/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/GKZ/K251249.md) | Tru Hematology Test | Truvian Sciences, Inc. | Jan 16, 2026 | SESE | | [K251371](https://fda.innolitics.com/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/GKZ/K251371.md) | Sysmex XR-Series (XR-20) Automated Hematology Analyzer | Sysmex America, Inc. | Jun 25, 2025 | SESE | | [K250943](https://fda.innolitics.com/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/GKZ/K250943.md) | Sysmex XR-Series (XR-10) Automated Hematology Analyzer | Sysmex America, Inc. | Jun 25, 2025 | SESE | | [K243283](https://fda.innolitics.com/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/GKZ/K243283.md) | Alinity h-series System | Abbott Laboratories | Feb 20, 2025 | SESE | | [K240402](https://fda.innolitics.com/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/GKZ/K240402.md) | Cito CBC System | Cytochip, Inc. | Feb 3, 2025 | SESE | | [K240252](https://fda.innolitics.com/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/GKZ/K240252.md) | UniCel DxH 900 Coulter Cellular Analysis System; UniCel DxH Slidemaker Stainer II Coulter Cellular Analysis System; UniCel DxH 690T Coulter Cellular Analysis System | Beckman Coulter, Inc. | Jul 5, 2024 | SESE | | [K232946](https://fda.innolitics.com/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/GKZ/K232946.md) | Yumizen H2500 | HORIBA ABX SAS | May 21, 2024 | SESE | | [K240636](https://fda.innolitics.com/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/GKZ/K240636.md) | HemoScreen Hematology Analyzer | Pixcell Medical Technologies | May 2, 2024 | SESE | | [K230887](https://fda.innolitics.com/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/GKZ/K230887.md) | Sysmex XQ-Series (XQ-320) Automated Hematology Analyzer | Sysmex America, Inc. | Dec 21, 2023 | SESE | | [K230878](https://fda.innolitics.com/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/GKZ/K230878.md) | QScout Lab; QScout RLD | Ad Astra Diagnostics, Inc. | Nov 14, 2023 | SESE | | [K222148](https://fda.innolitics.com/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/GKZ/K222148.md) | HemoScreen Hematology Analyzer | Pixcell Medical Technologies, Ltd. | Aug 16, 2023 | SESE | | [K220031](https://fda.innolitics.com/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/GKZ/K220031.md) | Alinity h-series System | Abbott Laboratories | Aug 4, 2023 | SESE | | [K210346](https://fda.innolitics.com/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/GKZ/K210346.md) | Sysmex XW-100 Automated Hematology Analyzer | Sysmex America, Inc. | Nov 8, 2022 | SESE | | [K211840](https://fda.innolitics.com/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/GKZ/K211840.md) | Sight OLO | S.D. Sight Diagnostics , Ltd. | May 9, 2022 | SESE | | [K200828](https://fda.innolitics.com/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/GKZ/K200828.md) | Athelas Home | Athelas, Inc. | Mar 22, 2022 | SESE | | [K193124](https://fda.innolitics.com/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/GKZ/K193124.md) | Unicel DxH 800 Coulter Cellular Analysis System | Beckman Coulter | Apr 16, 2020 | SESE | | [K190898](https://fda.innolitics.com/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/GKZ/K190898.md) | Sight OLO | Sight Diagnostics , Ltd. | Nov 1, 2019 | SESE | | [K182886](https://fda.innolitics.com/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/GKZ/K182886.md) | Cytomics FC 500 Series (MPL or MCL) Flow Cytometer | Beckman Coulter | Sep 6, 2019 | SESE | | [K190294](https://fda.innolitics.com/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/GKZ/K190294.md) | CELL-DYN Emerald 22 AL System | Abbott Laboratories | Mar 15, 2019 | SESE | ## Top Applicants - Beckman Coulter, Inc. — 25 clearances - Abbott Laboratories — 24 clearances - Coulter Corp. — 23 clearances - Becton Dickinson Immunocytometry Systems — 21 clearances - Sysmex America, Inc. — 21 clearances --- **Source:** [https://fda.innolitics.com/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/GKZ](https://fda.innolitics.com/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/GKZ) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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