# K101852: Chem Velocity Automated Urine Chemistry System, Strips and Calchek Kit

- Pathway: 510(k) (Traditional)
- Applicant: Iris International Inc., A Division of Iris Iris I
- Decided: Mar 23, 2011 after 265 days
- Product code: KQO (Automated Urinalysis System)
- Device class: 1
- Regulation: 21 CFR 862.2900
- Recalls of this device: 11 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K943592 (1994). 5 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K960054: 900UDX Urine Pathology System, Intl. Remote Imaging Systems (1996) Summary page 6.
- K013783: Aution Max AX-4280 Urinalysis System, International Remote Imaging Systems (2002) Summary page 6.
- (no number) iChem 100 Urine Chemistry Analyzer and iChem 10SG strips: named in the summary without a submission number

## Most influential descendants
- K171083: iChemVELOCITY Automated Urine Chemistry System (2017), 2 descendants of its own
- K210127: iQ200 System, iChemVELOCITY Automated Urine Chemistry System (2021), 1 descendant of its own
- K252580: iQ200 Series (2025), 0 descendants of its own

## Recalls of this device
- Mar 30, 2020 · Class II · Z-1944-2020: A defect in the SATA power adapter cable within the instruments computer has the potential risk for an electrical short that may lead to the following outcomes: charring and/or melting of the SATA ada
- Feb 17, 2020 · Class II · Z-1535-2020: The Leukocyte and Compensation pads were switched on some vials of lot number 7212269M of the iChem VELOCITY Strips.
- Nov 7, 2019 · Class II · Z-0843-2020: Beckman Coulter has become aware of an issue affecting Specific Gravity chemistry settings for the iChemVELOCITY Urine Chemistry System that prevents the trigger of a chemistry system flag S3 and may 
- Oct 28, 2019 · Class II · Z-0913-2020: 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
- Oct 18, 2018 · Class II · Z-1937-2019: Falsely elevated (false positive) urobilinogen patient results due to an increase in the sensitivity of the urobilinogen reaction.
- Mar 29, 2018 · Class II · Z-1894-2018: The Strip Provider Modules (SPM) on some of the instruments had not been inspected during manufacture for correct seal placement and integrity.
- Mar 2, 2018 · Class II · Z-1643-2018: Beckman Coulter has determined that there is a potential for incorrect settings to be installed on North American iChemVELOCITY Urine Chemistry Analyzers. 1. The installation of International settings
- Dec 4, 2017 · Class II · Z-1893-2018: A subset of Lot 7212154 A of the iChem VELOCITY Urine Chemistry strips has an incorrect pad placed in the location of the leukocytes pad. This will result in control CB failure for leukocytes and may 
- Jan 30, 2017 · Class II · Z-1384-2017: The probe misalignment or bending has the potential to lead to delay in reporting results or incorrect patient results.
- Jan 13, 2016 · Class II · Z-1067-2016: Iris International noted loose or missing analyte pads found in several locations (strip vial, strip provider module, strip conveyor system or waste container) that are undetectable by the iChemVELOCI
- Jul 15, 2015 · Class II · Z-2441-2015: Iris International is recalling the iChemVELOCITY systems because they do not maintain the on-board strip stability claim of 5 days at 18-28 degrees celsius at 20-80% relative humidity (RH) as stated 

## Indications for use
The iChem®VELOCITY™ 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 iChem VELOCITY can be used as a stand alone-system, as well as in an iQ&200 Series system, a configuration given the proprietary name iRICELL™ as it is designed to be hardware and software compatible with iQ200 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 nitrites, color and clarity. IChemVELOCITY strips are intended for use only with the iChem VELOCITY analyzer. In particular they are not intended for visual reading. The iChem VELOCITY test strips 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 iChem VELOCITY are intended for clinical laboratory use and in vitro diagnostic use only. The iChern®VELOCITY™ CaiChek Kit is a set of assayed and unassayed in vitro diagnostic controls for monitoring performance of the iChem VELOCITY urine chemistry analyzer. The controls include assayed liquid controls for the monitoring of the specific gravity measurement module, and unassayed liquid color and clarity controls for the monitoring of color and clarity measurements. The kit also includes a set of assayed reflectance strips for the monitoring of reflectance measurements. These measurements monitored by these controls are part of an automated urine chemistry analyzer used to aid in the diagnosis of metabolic disorders, kidney function anomalies, urinary tract infections, and liver function.

Source page: https://510kreport.com/device/K101852
Methodology: https://510kreport.com/methodology