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 864.5200](/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/864.5200) → LKM — Counter, Urine Particle # LKM · Counter, Urine Particle _Hematology · 21 CFR 864.5200 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/LKM ## Overview - **Product Code:** LKM - **Device Name:** Counter, Urine Particle - **Regulation:** [21 CFR 864.5200](/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/864.5200) - **Device Class:** 2 - **Review Panel:** [Hematology](/submissions/HE) - **3rd-party reviewable:** yes ## Identification An automated cell counter is a fully-automated or semi-automated device used to count red blood cells, white blood cells, or blood platelets using a sample of the patient's peripheral blood (blood circulating in one of the body's extremities, such as the arm). These devices may also measure hemoglobin or hematocrit and may also calculate or measure one or more of the red cell indices (the erythrocyte mean corpuscular volume, the mean corpuscular hemoglobin, or the mean corpuscular hemoglobin concentration). These devices may use either an electronic particle counting method or an optical counting method. ## Classification Rationale Class II (performance standards). ## Recent Cleared Devices (15 of 15) | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K252580](https://fda.innolitics.com/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/LKM/K252580.md) | iQ200 Series | Beckman Coulter, Inc. | Sep 10, 2025 | SESE | | [K232416](https://fda.innolitics.com/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/LKM/K232416.md) | AUTION EYE AI-4510 Urine Particle Analysis System | Arkray, Inc. | May 3, 2024 | SESE | | [K210127](https://fda.innolitics.com/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/LKM/K210127.md) | iQ200 System, iChemVELOCITY Automated Urine Chemistry System | Beckman Coulter, Inc. | Jul 2, 2021 | SESE | | [K200811](https://fda.innolitics.com/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/LKM/K200811.md) | cobas u 701 microscopy analyzer | Roche Diagnostics | Nov 6, 2020 | SESE | | [K171883](https://fda.innolitics.com/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/LKM/K171883.md) | Sysmex UF-5000 Fully Automated Urine Particle Analyzer | Sysmex America, Inc. | Apr 23, 2018 | SESE | | [K093861](https://fda.innolitics.com/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/LKM/K093861.md) | IQ 20 SERIES ANALYZER, IQ 200 SERIES SYSTEM, NAD IQ LAMINA CRADLE | Iris International, Inc. | Feb 5, 2010 | SESE | | [K083002](https://fda.innolitics.com/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/LKM/K083002.md) | SYSMEX UF-500I AUTOMATED URINE PARTICLE ANALYZER | Sysmex America, Inc. | Feb 3, 2009 | SESE | | [K080887](https://fda.innolitics.com/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/LKM/K080887.md) | SYSMEX UF-1000I, AUTOMATED URINE PARTICLE ANALYZER WITH URINALYSIS WAM SOFTWARE | Sysmex America, Inc. | May 2, 2008 | SESE | | [K070910](https://fda.innolitics.com/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/LKM/K070910.md) | SYSMEX MODEL UF1000I | Sysmex America, Inc. | May 25, 2007 | SESE | | [K053135](https://fda.innolitics.com/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/LKM/K053135.md) | SYSMEX UF-100I AUTOMATED URINE CELL ANALYZER | Sysmex America, Inc. | Jan 4, 2006 | SESE | | [K022774](https://fda.innolitics.com/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/LKM/K022774.md) | IQ 200 SYSTEM | Intl. Remote Imaging Systems | Oct 21, 2002 | SESE | | [K012372](https://fda.innolitics.com/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/LKM/K012372.md) | SYSMEX UF-50 | Sysmex Corp. | Sep 28, 2001 | SESE | | [K000373](https://fda.innolitics.com/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/LKM/K000373.md) | 939UDX URINE PATHOLOGY SYSTEM | Intl. Remote Imaging Systems | Apr 14, 2000 | SESE | | [K961054](https://fda.innolitics.com/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/LKM/K961054.md) | SYSMEX UF-100 | Sysmex Corp. | Oct 28, 1996 | SESE | | [K822823](https://fda.innolitics.com/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/LKM/K822823.md) | HEMATOLOGY COMPUTER-INTERFACE, VISCOUNT | Eko Scann AB | Oct 18, 1982 | SESE | ## Top Applicants - Sysmex America, Inc. — 5 clearances - Beckman Coulter, Inc. — 2 clearances - Intl. Remote Imaging Systems — 2 clearances - Sysmex Corp. — 2 clearances - Arkray, Inc. — 1 clearance --- **Source:** [https://fda.innolitics.com/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/LKM](https://fda.innolitics.com/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/LKM) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com