510(k) · Cleared
ClearedAUTION ELEVEN Semi-Automated Urinalysis System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Arkray, Inc. · JIL Method, Enzymatic, Glucose (Urinary, Non-Quantitative)
Cleared on Oct 7, 2016 as substantially equivalent to K093098 (Arkray, Inc., 2009) and 1 other predicate after a 269-day review. Its family tree reaches back 4 generations to 1994.
- Decided
- Oct 7, 2016
- Review
- 269 days
- Class
- Class II
- Product code
- JIL
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K943592 (1994). 6 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 deviceK160062 AUTION ELEVEN Semi-Automated Urinalysis SystemArkray, Inc. · 2016
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) | K160062 | AUTION ELEVEN Semi-Automated Urinalysis System | Arkray, Inc. | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
| 2009 | 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? (2)
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 |
|---|---|---|---|
| * | K093098 | Aution Max Model AX-4030 Urinalysis SystemSummary page 5…Class I Test, Urine Leukocyte 862.2800 JRE Class I Specific Gravity Predicate Devices AUTION MAX AX-4030 Urinalysis System (K093098) Intended Use The AUTION ELEVEN Semi-Automated Urinalysis System provides a qualitative and semi-quantitative me… | 2009 |
| * | K030600 | Aution Jet AJ-4270 Urine AnalyzerSummary page 9…to AUTION JET (k030600) for specific… | 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)
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 22 years and passes through 3 companies; a new generation was cleared every 4.0 years on median.
- None of the 6 ancestors has a recall.
- 3 other devices also cite its predicate K093098.
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. 2016, 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 AUTION ELEVEN Semi-Automated Urinalysis System provides a qualitative and semi-quantitative measurements
for glucose, protein, bilirubin, urobilinogen, pH, blood, ketones, nitrites, leukocytes, specific gravity and color tone in
urine specimens. The system is intended for in vitro diagnostic use in screening patient populations found in clinical
laboratories.
The AUTION ELEVEN Semi-Automated Urinalysis System consists of the following:
• AUTION ELEVEN model AE-4022 Urine Analyzer (device component)
• AUTION Sticks 10EA Test Strips (reagent component)
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K160062 · printed Nov 4, 2026
Cite this page
510(k) Report. “K160062: AUTION ELEVEN Semi-Automated Urinalysis System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K160062
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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