510(k) · Cleared
ClearedAUTION MAX AX-4060 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 Apr 13, 2023 as substantially equivalent to K093098 (Arkray, Inc., 2009) and 1 other predicate after a 1,211-day review. Its family tree reaches back 4 generations to 1994.
- Decided
- Apr 13, 2023
- Review
- 1,211 days
- Class
- Class II
- Product code
- JIL
- Recalls
- None
- Predicates
- 2
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 backK093098 Aution Max Model AX-4030 Urinalysis SystemArkray, Inc. · 2009
- This deviceK193514 AUTION MAX AX-4060 Urinalysis SystemArkray, Inc. · 2023
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 | K093098 | Aution Max Model AX-4030 Urinalysis System | Arkray, Inc. | 2009 | — |
| 0 (this device) | K193514 | AUTION MAX AX-4060 Urinalysis System | Arkray, Inc. | 2023 | — |
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.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
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 6…K193514 Predicate Device: 1. AUTION MAX AX-4030 Fully Automated Urinalysis System (K093098) 2. AUTION Sticks 9EB (K013783) Regulatory Information: Regulatory Classification for Urinalysis system and each of… | 2009 |
| * | K013783 | Aution Max AX-4280 Urinalysis SystemSummary page 6…K193514 Predicate Device: 1. AUTION MAX AX-4030 Fully Automated Urinalysis System (K093098) 2. AUTION Sticks 9EB (K013783) Regulatory Information: Regulatory Classification for Urinalysis system and each of the tests are listed in Table 1.… | 2002 |
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 29 years and passes through 3 companies; a new generation was cleared every 7.9 years on median.
- None of the 5 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. 2023, 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 MAX AX-4060 Urinalysis System (AUTION MAX) is comprised of the AUTION MAX AX-4060 automated urine analyzer and AUTION Sticks 9EB multi-parameter test strips. The AUTION MAX AX-4060 urine analyzer, when used with AUTION Sticks 9EB test strips is a fully automated urinalysis system intended for the in vitro qualitative or semi-quantitative measurement of the following analytes: glucose, protein, bilirubin, urobilinogen, pH, blood, ketones…
Read the full statement (160 words)
The AUTION MAX AX-4060 Urinalysis System (AUTION MAX) is comprised of the AUTION MAX AX-4060 automated urine analyzer and AUTION Sticks 9EB multi-parameter test strips.
The AUTION MAX AX-4060 urine analyzer, when used with AUTION Sticks 9EB test strips is a fully automated urinalysis system intended for the in vitro qualitative or semi-quantitative measurement of the following analytes: glucose, protein, bilirubin, urobilinogen, pH, blood, ketones, nitrite, leukocytes, turbidity, and color. The test results of these parameters can be used in the evaluation of kidney, urinary, liver and other metabolic disorders. This system is intended to be used by trained operators in clinical laboratories.
AUTION Sticks 9EB test strips are test strips for the in vitro qualitative or semi-quantitative measurement of the following analytes: glucose, protein, bilirubin, urobilinogen, pH, blood, ketones, nitrite, and leukocytes with the AUTION MAX AX-4060 urine analyzer. The test results of these parameters can be used in the evaluation of kidney, urinary, liver and other metabolic disorders.
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/K193514 · printed Nov 6, 2026
Cite this page
510(k) Report. “K193514: AUTION MAX AX-4060 Urinalysis System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K193514
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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