510(k) · Cleared
Recalled · Class II · 2020Chem Velocity Automated Urine Chemistry System, Strips and Calchek Kit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Iris International Inc., A Division of Iris Iris I · KQO Automated Urinalysis System
Cleared on Mar 23, 2011 as substantially equivalent to K960054 (Intl. Remote Imaging Systems, 1996) and 1 other predicate after a 265-day review. Its family tree reaches back 3 generations to 1994. 3 later devices descend from it. It has been recalled 11 times.
- Decided
- Mar 23, 2011
- Review
- 265 days
- Class
- Class I
- Product code
- KQO
- Recalls
- 11
- Predicates
- 2
Its longest line of descent runs back 3 generations to K943592 (1994). 5 ancestors in all. 3 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK943592 Chemstrip Mini UA Urine AnalyzerBoehringer Mannheim Corp. · 1994
- 2 generations backK983510 Chemstrip 101 Urine AnalyzerBoehringer Mannheim Corp. · 1998
- 1 generation backK013783 Aution Max AX-4280 Urinalysis SystemInternational Remote Imaging Systems · 2002
- This deviceK101852 Chem Velocity Automated Urine Chemistry System, Strips and Calchek KitIris International Inc., A Division of Iris Iris I · 2011
- Descendant · cites it directly · 2 of its ownK171083 iChemVELOCITY Automated Urine Chemistry SystemIris Diagnostics, A Division of Iris International, Inc. · 2017
- Descendant · cites it directly · 1 of its ownK210127 iQ200 System, iChemVELOCITY Automated Urine Chemistry SystemBeckman Coulter, Inc. · 2021 · Recalled
- Descendant · 2 generations on · 0 of its ownK252580 iQ200 SeriesBeckman Coulter, Inc. · 2025 · Recalled
Most influential descendants
Showing 3 of 3 · See all- K171083iChemVELOCITY Automated Urine Chemistry SystemIris Diagnostics, A Division of Iris International, Inc. · 2017 · cites it directly2descendants
- K210127iQ200 System, iChemVELOCITY Automated Urine Chemistry SystemBeckman Coulter, Inc. · 2021 · cites it directly1descendant
- K252580iQ200 SeriesBeckman Coulter, Inc. · 2025 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K943592 | Chemstrip Mini UA Urine Analyzer | Boehringer Mannheim Corp. | 1994 | — |
| −2 | K983510 | Chemstrip 101 Urine Analyzer | Boehringer Mannheim Corp. | 1998 | — |
| −1 | K013783 | Aution Max AX-4280 Urinalysis System | International Remote Imaging Systems | 2002 | — |
| 0 (this device) | K101852 | Chem Velocity Automated Urine Chemistry System, Strips and Calchek Kit | Iris International Inc., A Division of Iris Iris I | 2011 | — |
| +1 | K171083 | iChemVELOCITY Automated Urine Chemistry System | Iris Diagnostics, A Division of Iris International, Inc. | 2017 | — |
| +1 | K210127 | iQ200 System, iChemVELOCITY Automated Urine Chemistry System | Beckman Coulter, Inc. | 2021 | 6 |
| +2 | K252580 | iQ200 Series | Beckman Coulter, Inc. | 2025 | 2 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 2021 | 1 | 0 |
| 2025 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in KQO? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (3)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K960054 | 900UDX Urine Pathology SystemSummary page 6…ssified: Urinary Color, Urinary Clarity (Turbidity) Device to which substantial equivalence is claimed IRISpec Gravity Control 1 and IRISpec Gravity Control 2Th File No. K960054 Arkray Check Strips K01 3783 Description of the proposed device: iChem VELOCITY CalChek Reagents are a set of buffer-based soluti… | 1996 |
| * | K013783 | Aution Max AX-4280 Urinalysis SystemSummary page 6…ary Clarity (Turbidity) Device to which substantial equivalence is claimed IRISpec Gravity Control 1 and IRISpec Gravity Control 2Th File No. K960054 Arkray Check Strips K01 3783 Description of the proposed device: iChem VELOCITY CalChek Reagents are a set of buffer-based solutions intended for the in vitro… | 2002 |
| * | — | iChem 100 Urine Chemistry Analyzer and iChem 10SG strips Named without a submission number |
What descends from it? (3)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Mar 30, 2020 | Class II | Z-1944-2020 | Nonconforming Material/Component | 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 adapter cable within the computers metal… |
| Feb 17, 2020 | Class II | Z-1535-2020 | Under Investigation by firm | 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 | Error in labeling | 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 result in erroneous Specific Gravity… |
| Oct 28, 2019 | Class II | Z-0913-2020 | Software in the Use Environment | 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 identification (demographics). |
| Oct 18, 2018 | Class II | Z-1937-2019 | Component change control | 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 | Process control | 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 | Under Investigation by firm | 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 can result in the generation of… |
| Dec 4, 2017 | Class II | Z-1893-2018 | Mixed-up of materials/components | 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 generate false negative erroneous… |
| Jan 30, 2017 | Class II | Z-1384-2017 | Device Design | 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 | Equipment maintenance | 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 iChemVELOCITY System. |
| Jul 15, 2015 | Class II | Z-2441-2015 | Nonconforming Material/Component | 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 in the iChemVELOCITY product labeling. |
The 5 latest of 11 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 17 years and passes through 3 companies; a new generation was cleared every 4.0 years on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K171083 (Iris Diagnostics, A Division of Iris International, Inc., 2017) has gone furthest, with 2 descendants of its own.
How does its category compare?
All KQO devicesKQO Automated Urinalysis System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.
FDA decisions per year · KQO
2in 2015
2026 to Oct 25, outlined.
Median 510(k) review, days · KQO
Too few KQO 510(k)s in any year since 2007 to give a median.
Recalls per year · KQO
1in 2021
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KQO
12in 2025
MAUDE reports naming product code KQO, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 1 | — | 0 | 1 |
| 2008 | 0 | — | 0 | 4 |
| 2009 | 1 | — | 0 | 9 |
| 2010 | 2 | — | 7 | 3 |
| 2011 | 2 | — | 2 | 8 |
| 2012 | 0 | — | 0 | 15 |
| 2013 | 1 | — | 1 | 92 |
| 2014 | 1 | — | 0 | 106 |
| 2015 | 2 | — | 0 | 238 |
| 2016 | 0 | — | 1 | 373 |
| 2017 | 0 | — | 0 | 20 |
| 2018 | 0 | — | 0 | 25 |
| 2019 | 0 | — | 2 | 64 |
| 2020 | 0 | — | 0 | 21 |
| 2021 | 0 | — | 1 | 13 |
| 2022 | 0 | — | 0 | 15 |
| 2023 | 0 | — | 0 | 19 |
| 2024 | 0 | — | 0 | 20 |
| 2025 | 0 | — | 0 | 12 |
| 2026 | 0 | — | 2 | — |
What is it indicated for?
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…
Read the full statement (283 words)
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K101852 · printed Nov 4, 2026
Cite this page
510(k) Report. “K101852: Chem Velocity Automated Urine Chemistry System, Strips and Calchek Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K101852
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026