# K210127: iQ200 System, iChemVELOCITY Automated Urine Chemistry System

- Pathway: 510(k) (Traditional)
- Applicant: Beckman Coulter, Inc.
- Decided: Jul 2, 2021 after 164 days
- Product code: LKM (Counter, Urine Particle)
- Device class: 2
- Regulation: 21 CFR 864.5200
- Recalls of this device: 6 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K943592 (1994). 17 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K022774: IQ 200 System, Intl. Remote Imaging Systems (2002) Summary page 4.
- K050235: IQ 200 Urine Analyzer Body Fluids Module, Iris International, Inc. (2005) Summary page 4.
- K093861: IQ 20 Series Analyzer, IQ 200 Series System, Nad IQ Lamina Cradle, Iris International, Inc. (2010) Summary page 4.
- K091539: IQ 200 Urine Analizer Body Fluids Module, Iris Diagnostics (2010) Summary page 4.
- K101852: Chem Velocity Automated Urine Chemistry System, Strips and Calchek Kit, Iris International Inc., A Division of Iris Iris I (2011) Summary page 4.
- K171083: iChemVELOCITY Automated Urine Chemistry System, Iris Diagnostics, A Division of Iris International, Inc. (2017) Summary page 5.

## Most influential descendants
- K252580: iQ200 Series (2025), 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
- 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.

## Indications for use
1Q200 System: The 1Q200 automated urine microscopy system is an in vitro diagnostic device used to automate the complete urinalysis profile, including urine test strip chemistry panel and microscopic sediment analysis. Optionally, the Q200 analyzer can be used as a stand-alone unit, or the results from the Q200 analyzer can be combined with other urine chemistry results received from an LIS. It produces quantitative or qualitative counts of all formed sediment elements present in urine, including cells, casts, crystals, and organisms. A competent human operator can set criteria for auto-reporting and flagging specimens for review. All instrument analyte image decisions may be reviewed and overridden by a trained technologist. iChemVELOCITY Automated Urine Chemistry System: The iChemVELOCITY automated urine chemistry system is an in vitro diagnostic device used to automate the urine chemistry analysis profile using iChem VELOCITY Urine Chemistry Strips. The iChemVELOCITY can be used as a stand-alone system, as well as in an iQ200 Series system, a configuration given the proprietary name iRICELL as it is designed to be hardware and software compatible with Q200 Series systems. It produces quantitative results for specific gravity; semi-quantitative results for glucose, blood, leukocyte esterase, bilirubin, urobilinogen, pH, protein, ketones and ascorbic acid; and qualitative results for nitrite, color and clarity. iChemVELOCITY strips are intended for use only with the iChemVELOCITY analyzer. In particular, they are not intended for visual reading. The iChemVELOCITY is not intended to be used as a Point of Care (POC) analyzer. These measurements are used to aid in the diagnosis of metabolic disorders, kidney function anomalies, urinary tract infections, and liver function. Tests performed using the iChemVELOCITY are intended for clinical laboratory use and in vitro diagnostics use only.

Source page: https://510kreport.com/device/K210127
Methodology: https://510kreport.com/methodology