# K022774: IQ 200 System - Pathway: 510(k) (Traditional) - Applicant: Intl. Remote Imaging Systems - Decided: Oct 21, 2002 after 61 days - Product code: LKM (Counter, Urine Particle) - Device class: 2 - Regulation: 21 CFR 864.5200 - Recalls of this device: 14 (0 Class I) - Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026 ## Lineage No predicates in its family tree. 3 later devices descend from it; 3 cite it directly. 0 of 4 devices in its family (counting itself) have a Class I recall. ## Predicates on the family tree (from the FDA summary) - None. The FDA summary names its predicate without a number. - (no number) The Yellow IRIS Urinalysis Workstation with CHEMSTRIP Reader: named in the summary without a submission number - (no number) IRIS Flow Microscope: named in the summary without a submission number - (no number) 900UDx Urine Pathology System: named in the summary without a submission number - (no number) 939UDx Urine Pathology System: named in the summary without a submission number - (no number) Sysmex UF-100: named in the summary without a submission number ## Most influential descendants - K210127: iQ200 System, iChemVELOCITY Automated Urine Chemistry System (2021), 1 descendant of its own - K252580: iQ200 Series (2025), 0 descendants of its own - K200811: cobas u 701 microscopy analyzer (2020), 0 descendants of its own ## Recalls of this device - Aug 12, 2026 · Class II · Z-0161-2027: The rinse-line check valve has a shorter service lifespan than originally expected and requires annual replacement to prevent lamina fluid leakage; however, the check valve replacement was excluded fr - Aug 12, 2026 · Class II · Z-0160-2027: The rinse-line check valve has a shorter service lifespan than originally expected and requires annual replacement to prevent lamina fluid leakage; however, the check valve replacement was excluded fr - Dec 19, 2023 · Class II · Z-0784-2024: Beckman Coulter has become aware that the cannula, which is found in the Flowcell and the iQClear Rinse Waste Well Assembly, may rust. Rust from the cannula has the potential to generate erroneous res - Dec 19, 2023 · Class II · Z-0787-2024: Beckman Coulter has become aware that the cannula, which is found in the Flowcell and the iQClear Rinse Waste Well Assembly, may rust. Rust from the cannula has the potential to generate erroneous res - Dec 19, 2023 · Class II · Z-0786-2024: Beckman Coulter has become aware that the cannula, which is found in the Flowcell and the iQClear Rinse Waste Well Assembly, may rust. Rust from the cannula has the potential to generate erroneous res - Dec 19, 2023 · Class II · Z-0785-2024: Beckman Coulter has become aware that the cannula, which is found in the Flowcell and the iQClear Rinse Waste Well Assembly, may rust. Rust from the cannula has the potential to generate erroneous res - Apr 5, 2023 · Class II · Z-1597-2023: Beckman Coulter has become aware of an intermittent issue in which the optional flag "Previous Sample Had Sperm" was enabled but not displayed so that a carryover event could have been investigated. - Apr 5, 2023 · Class II · Z-1599-2023: Beckman Coulter has become aware of an intermittent issue in which the optional flag "Previous Sample Had Sperm" was enabled but not displayed so that a carryover event could have been investigated. - Apr 5, 2023 · Class II · Z-1596-2023: Beckman Coulter has become aware of an intermittent issue in which the optional flag Previous Sample Had Sperm was enabled but not displayed so that a carryover event could have been investigated. - Apr 5, 2023 · Class II · Z-1598-2023: Beckman Coulter has become aware of an intermittent issue in which the optional flag "Previous Sample Had Sperm" was enabled but not displayed so that a carryover event could have been investigated. - Mar 30, 2020 · Class II · Z-1945-2020: A defect in the SATA power adapter cable within the instrument s computer has the potential risk for an electrical short that may lead to the following outcomes: charring and/or melting of the SATA ad - Oct 28, 2019 · Class II · Z-0914-2020: Customers have reported incidents where two sets of results report the same Specimen Identifier (Specimen ID) with different results, different Medical Record Number (MRN) and different patient identi - Mar 2, 2018 · Class II · Z-1362-2018: Beckman Coulter has determined that there is a potential for under-reporting casts. This can occur if per high-power field (/HPF) units of measurement for casts are selected in the iQ200 software, but - Nov 10, 2017 · Class II · Z-1366-2018: iQ200 Series Urine Microscopy Analyzer may intermittently fail to read urine sample dilution barcode labels causing erroneous results that could delay treatment for health conditions such as hematuria ## Indications for use The iQ 200 System is intended for analysis of urine chemistry, specific gravity, and formed sediment elements, which constitutes typical routine urinalysis. Urinalysis is ordered by physicians as a screening procedure for detection of possible abnormal metabolic or systemic disease, indicated by chemical composition of urine, and of potential renal or urinary tract disease or dysfunction, indicated by urine concentration and by the nature and distribution of urinary formed elements. Urine profile testing is commonly employed in the initial clinical evaluation of patients admitted for hospital care or undergoing physical examinations. Routine urinalysis is also indicated in diagnosis of patients with possible renal or urinary tract infection, carcinoma, or other injury, as well as for monitoring the status and effectiveness of drug, radiation, or dietary therapy, and of post-surgical or post-therapeutic recovery. The information produced by the iQ 200 System concerning the composition of patient urines is ordered at the discretion of the physician, and is part of a larger body of laboratory and other test results available to assist the physician in health assessments or differential diagnoses. Routine urinalysis findings are always subject to judgment and interpretation by physicians relative to the patient's overall clinical presentation and history. Source page: https://510kreport.com/device/K022774 Methodology: https://510kreport.com/methodology