510(k) · Cleared
ClearediChemVELOCITY Automated Urine Chemistry System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Iris Diagnostics, A Division of Iris International, Inc. · JIL Method, Enzymatic, Glucose (Urinary, Non-Quantitative)
Cleared on May 12, 2017 as substantially equivalent to K101852 (Iris International Inc., A Division of Iris Iris I, 2011) after a 31-day review. Its family tree reaches back 4 generations to 1994. 2 later devices descend from it.
- Decided
- May 12, 2017
- Review
- 31 days
- Class
- Class II
- Product code
- JIL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K943592 (1994). 6 ancestors in all. 2 later devices descend from it, 1 citing it directly.
- Root · 4 generations backK943592 Chemstrip Mini UA Urine AnalyzerBoehringer Mannheim Corp. · 1994
- 3 generations backK983510 Chemstrip 101 Urine AnalyzerBoehringer Mannheim Corp. · 1998
- 2 generations backK013783 Aution Max AX-4280 Urinalysis SystemInternational Remote Imaging Systems · 2002
- 1 generation backK101852 Chem Velocity Automated Urine Chemistry System, Strips and Calchek KitIris International Inc., A Division of Iris Iris I · 2011 · Recalled
- This deviceK171083 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 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K943592 | Chemstrip Mini UA Urine Analyzer | Boehringer Mannheim Corp. | 1994 | — |
| −3 | K983510 | Chemstrip 101 Urine Analyzer | Boehringer Mannheim Corp. | 1998 | — |
| −2 | K013783 | Aution Max AX-4280 Urinalysis System | International Remote Imaging Systems | 2002 | — |
| −1 | K101852 | Chem Velocity Automated Urine Chemistry System, Strips and Calchek Kit | Iris International Inc., A Division of Iris Iris I | 2011 | 11 |
| 0 (this device) | 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 |
|---|---|---|
| 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 JIL? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new JIL device
- #1 K193514 AUTION MAX AX-4060 Urinalysis Systemscore 6.1 · 4 generations · no Class I recall
What was it cleared against? (1)
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 |
|---|---|---|---|
| * | K101852 | Chem Velocity Automated Urine Chemistry System, Strips and Calchek KitSummary page 5…Candidate Predicate Manufacturer 510(k) No. Date Cleared iChemVELOCITY iChemVELOCITY Iris Diagnostics, K101852 03/23/2011 with re-designed a Division of Iris CGM… | 2011 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K210127 | iQ200 System, iChemVELOCITY Automated Urine Chemistry System | 2021 | 1 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 23 years and passes through 4 companies; a new generation was cleared every 6.1 years on median.
- 1 of the 6 ancestors has a recall of any class.
- Of its descendants, K210127 (Beckman Coulter, Inc., 2021) has gone furthest, with 1 descendant of its own.
- 1 other device also cites its predicate K101852.
How does its category compare?
All JIL devicesJIL Method, Enzymatic, Glucose (Urinary, Non-Quantitative): FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, this device’s year, is highlighted.
FDA decisions per year · JIL
1in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · JIL
187in 2018
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JIL
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JIL
15in 2025
MAUDE reports naming product code JIL, 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 | 3 | 284 | 0 | 20 |
| 2008 | 0 | — | 0 | 20 |
| 2009 | 1 | — | 0 | 16 |
| 2010 | 0 | — | 0 | 11 |
| 2011 | 1 | — | 0 | 14 |
| 2012 | 1 | — | 0 | 5 |
| 2013 | 0 | — | 0 | 32 |
| 2014 | 1 | — | 4 | 47 |
| 2015 | 1 | — | 0 | 45 |
| 2016 | 2 | — | 1 | 40 |
| 2017 | 1 | — | 0 | 33 |
| 2018 | 4 | 187 | 0 | 68 |
| 2019 | 1 | — | 0 | 67 |
| 2020 | 0 | — | 0 | 23 |
| 2021 | 0 | — | 0 | 12 |
| 2022 | 0 | — | 0 | 14 |
| 2023 | 1 | — | 0 | 15 |
| 2024 | 0 | — | 0 | 21 |
| 2025 | 0 | — | 1 | 15 |
| 2026 | 0 | — | 0 | — |
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 iChemVELOCITY 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 (168 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 iChemVELOCITY 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 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 and in vitro diagnostic use only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K171083 · printed Nov 6, 2026
Cite this page
510(k) Report. “K171083: iChemVELOCITY Automated Urine Chemistry System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K171083
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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