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 864.5260](/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/864.5260) → JOY — Device, Automated Cell-Locating # JOY · Device, Automated Cell-Locating _Hematology · 21 CFR 864.5260 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/JOY ## Overview - **Product Code:** JOY - **Device Name:** Device, Automated Cell-Locating - **Regulation:** [21 CFR 864.5260](/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/864.5260) - **Device Class:** 2 - **Review Panel:** [Hematology](/submissions/HE) - **3rd-party reviewable:** yes ## Identification An automated cell-locating device is a device used to locate blood cells on a peripheral blood smear, allowing the operator to identify and classify each cell according to type. (Peripheral blood is blood circulating in one of the body's extremities, such as the arm.) ## Classification Rationale Class II (performance standards). ## Recent Cleared Devices (20 of 35) Showing 20 most recent of 35 cleared devices. | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K243144](https://fda.innolitics.com/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/JOY/K243144.md) | X100/X100HT with Full Field Peripheral Blood Smear (PBS) Application | Scopio Labs , Ltd. | Jun 27, 2025 | SESE | | [K221309](https://fda.innolitics.com/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/JOY/K221309.md) | AI100 with Shonit | Sigtuple Technologies Pvt. , Ltd. | Sep 19, 2023 | SESE | | [K220013](https://fda.innolitics.com/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/JOY/K220013.md) | X100HT with Slide Loader with Full Field Peripheral Blood Smear (PBS) Application | Scopio Labs , Ltd. | May 3, 2022 | SESE | | [K200595](https://fda.innolitics.com/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/JOY/K200595.md) | CellaVision DC-1, CellaVision DC-1 PPA | CellaVision AB | Oct 16, 2020 | SESE | | [K201301](https://fda.innolitics.com/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/JOY/K201301.md) | X100 with Full Field Peripheral Blood Smear (PBS) Application | Scopio Labs , Ltd. | Oct 2, 2020 | SESE | | [K182062](https://fda.innolitics.com/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/JOY/K182062.md) | Sysmex UD-10, Fully Automated Urine Particle Digital Imaging Device | Sysmex America, Inc. | Oct 30, 2018 | SESE | | [K171315](https://fda.innolitics.com/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/JOY/K171315.md) | Advanced RBC Application | CellaVision AB | Aug 1, 2017 | SESE | | [K102778](https://fda.innolitics.com/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/JOY/K102778.md) | CELLAVISION DM1200 WITH THE BODY FLUID APPLICTION | CellaVision AB | Sep 16, 2011 | SESE | | [K092116](https://fda.innolitics.com/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/JOY/K092116.md) | EASYCELL CELL LOCATOR | Medica Corp. | May 12, 2010 | SESE | | [K092868](https://fda.innolitics.com/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/JOY/K092868.md) | CELLAVISION DM1200 AUTOMATED HEMATOLOGY ANALYZER, MODEL XU-10127 | CellaVision AB | Nov 20, 2009 | SESE | | [K080595](https://fda.innolitics.com/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/JOY/K080595.md) | CELLAVISION DM96 WITH THE BODY FLUID APPLICATION | CellaVision AB | Dec 5, 2008 | SESE | | [K071398](https://fda.innolitics.com/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/JOY/K071398.md) | SCANVIEW, MODEL SC-300 | Applied Spectral Imaging , Ltd. | Oct 4, 2007 | SESE | | [K061602](https://fda.innolitics.com/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/JOY/K061602.md) | DUET SYSTEM | Bioview , Ltd. | Jan 23, 2007 | SESE | | [K062755](https://fda.innolitics.com/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/JOY/K062755.md) | IKONISCOPE ONCOFISH BLADDER TEST SYSTEM | Ikonisys, Inc. | Jan 4, 2007 | SESE | | [K061392](https://fda.innolitics.com/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/JOY/K061392.md) | IKONISCOPE FASTFISH AUTO/AMNIOCYTE TEST SYSTEM | Ikonisys, Inc. | Aug 1, 2006 | SESE | | [K052577](https://fda.innolitics.com/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/JOY/K052577.md) | IKONISCOPE FASTFISH AMNIO IMAGING SYSTEM | Ikonisys, Inc. | Jan 24, 2006 | SESE | | [K050840](https://fda.innolitics.com/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/JOY/K050840.md) | MODIFICATION TO DUET SYSTEM | Bioview , Ltd. | Aug 16, 2005 | SESE | | [K040591](https://fda.innolitics.com/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/JOY/K040591.md) | DUET SYSTEM | Bioview , Ltd. | Sep 16, 2004 | SESE | | [K033840](https://fda.innolitics.com/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/JOY/K033840.md) | CELLAVISION DM96 AUTOMATIC HEMATOLOGY ANALYZER | CellaVision AB | Feb 10, 2004 | SESE | | [K030192](https://fda.innolitics.com/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/JOY/K030192.md) | DUET SYSTEM | Bioview , Ltd. | Aug 20, 2003 | SESE | ## Top Applicants - CellaVision AB — 7 clearances - Triangle Biomedical Sciences, Inc. — 5 clearances - Bioview , Ltd. — 4 clearances - Ikonisys, Inc. — 3 clearances - Scopio Labs , Ltd. — 3 clearances --- **Source:** [https://fda.innolitics.com/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/JOY](https://fda.innolitics.com/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/JOY) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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