510(k) · Cleared
Recalled · Class II · 2014Ichem 100 Urine Chemistry Analyzer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Iris International, Inc. · JIL Method, Enzymatic, Glucose (Urinary, Non-Quantitative)
Cleared on Jun 13, 2006 as substantially equivalent to K030600 (International Remote Imaging Systems, 2003) after a 131-day review. Its family tree reaches back 4 generations to 1994. It has been recalled once.
- Decided
- Jun 13, 2006
- Review
- 131 days
- Class
- Class II
- Product code
- JIL
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 4 generations to K943592 (1994). 5 ancestors in all. No later device cites it as a predicate yet.
- 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 backK030600 Aution Jet AJ-4270 Urine AnalyzerInternational Remote Imaging Systems · 2003
- This deviceK060280 Ichem 100 Urine Chemistry AnalyzerIris International, Inc. · 2006
View 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 | K030600 | Aution Jet AJ-4270 Urine Analyzer | International Remote Imaging Systems | 2003 | — |
| 0 (this device) | K060280 | Ichem 100 Urine Chemistry Analyzer | Iris International, Inc. | 2006 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 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 |
|---|---|---|---|
| * | K030600 | Aution Jet AJ-4270 Urine AnalyzerSummary page 1…l Name: Urine Analyzer Classification Name: Automated Urinalysis System PREDICATE DEVICE: ARKRAY AUTION JET TuAJ~4270 Urine Analyzer (k030600) DEVICE DESCRIPTION: The iChemT lOO Urine Chemistry Analyzer is a semi-automated benchtop4 ins… | 2003 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Dec 8, 2014 | Class II | Z-0649-2016 | Nonconforming Material/Component | Iris International is recalling the iChem 10 SG Urine Chemistry Strip because of false positive leukocyte result for samples that are truly negative. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 12 years and passes through 3 companies; a new generation was cleared every 3.2 years on median.
- None of the 5 ancestors has a recall.
- 1 other device also cites its predicate K030600.
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.
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 iChem100 Urine Chemistry Analyzer (iChem100) is a semi-automated benchtop urine chemistry analyzer intended for the in vitro measurement of the following analytes: glucose, protein, bilirubin, uroDilinogen, pH, specific gravity, blood, ketones, nitrite, leukocyte esterase, ascorbic acid, and color. The iChem100 is intended for use only with iChem 10 SG Urine Chemistry Strips provided by Iris Diagnostics and is intended for use exclusively by healthcare professionals.
These measurements are useful in the evaluation of renal, urinary, and metabolic disorders.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K060280 · printed Nov 6, 2026
Cite this page
510(k) Report. “K060280: Ichem 100 Urine Chemistry Analyzer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K060280
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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