510(k) Report

510(k) · Cleared

Cleared

Aution Max AX-4280 Urinalysis System

K013783510(k) TraditionalCleared Jan 18, 200265-day reviewClass I21 CFR 862.2900

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

International Remote Imaging Systems · KQO Automated Urinalysis System

Cleared on Jan 18, 2002 as substantially equivalent to K946183 (Heraeus Kulzer, Inc., 1995) and 1 other predicate after a 65-day review. Its family tree reaches back 2 generations to 1994. 11 later devices descend from it.

Decided
Jan 18, 2002
Review
65 days
Class
Class I
Product code
KQO
Recalls
None
Predicates
2

Its longest line of descent runs back 2 generations to K943592 (1994). 3 ancestors in all. 11 later devices descend from it, 4 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 1995: 1 other ancestor2011: 1 descendant cleared2023: 1 descendant cleared2009: 1 descendant cleared2003: 1 descendant cleared2006: 1 descendant cleared2016: 1 descendant cleared2013: 1 descendant cleared2024: 1 descendant cleared2021: 1 descendant cleared2017: 1 descendant cleared2025: 1 descendant clearedK943592 · Chemstrip Mini UA Urine Analyzer · Boehringer Mannheim Corp. · 1994K983510 · Chemstrip 101 Urine Analyzer · Boehringer Mannheim Corp. · 19981990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 1 other ancestor 1 generation forward: 4 descendants2 generations forward: 6 descendants3 generations forward: 1 descendant K983510 · Chemstrip 101 Urine Analyzer · Boehringer Mannheim Corp. · 1998K943592 · Chemstrip Mini UA Urine Analyzer · Boehringer Mannheim Corp. · 19940
  1. Root · 2 generations backK943592 Chemstrip Mini UA Urine AnalyzerBoehringer Mannheim Corp. · 1994
  2. 1 generation backK983510 Chemstrip 101 Urine AnalyzerBoehringer Mannheim Corp. · 1998
  3. This deviceK013783 Aution Max AX-4280 Urinalysis SystemInternational Remote Imaging Systems · 2002
  4. Descendant · cites it directly · 4 of its ownK093098 Aution Max Model AX-4030 Urinalysis SystemArkray, Inc. · 2009
  5. Descendant · cites it directly · 3 of its ownK101852 Chem Velocity Automated Urine Chemistry System, Strips and Calchek KitIris International Inc., A Division of Iris Iris I · 2011 · Recalled
  6. Descendant · 2 generations on · 2 of its ownK171083 iChemVELOCITY Automated Urine Chemistry SystemIris Diagnostics, A Division of Iris International, Inc. · 2017
  7. Descendant · cites it directly · 2 of its ownK030600 Aution Jet AJ-4270 Urine AnalyzerInternational Remote Imaging Systems · 2003
  8. Descendant · 2 generations on · 1 of its ownK210127 iQ200 System, iChemVELOCITY Automated Urine Chemistry SystemBeckman Coulter, Inc. · 2021 · Recalled

Showing 5 of 11 descendants. See all descendants

Descendants cleared per year

2003: 12006: 12009: 12011: 12013: 12016: 12017: 12021: 12023: 12024: 12025: 1
2003high 1 (2003) · low 0 (2004)2026

Most influential descendants

Showing 5 of 11 · See all
  • K093098Aution Max Model AX-4030 Urinalysis SystemArkray, Inc. · 2009 · cites it directly4descendants
  • K101852Chem Velocity Automated Urine Chemistry System, Strips and Calchek KitIris International Inc., A Division of Iris Iris I · 2011 · cites it directly3descendants
  • K171083iChemVELOCITY Automated Urine Chemistry SystemIris Diagnostics, A Division of Iris International, Inc. · 2017 · 2 generations on2descendants
  • K030600Aution Jet AJ-4270 Urine AnalyzerInternational Remote Imaging Systems · 2003 · cites it directly2descendants
  • K210127iQ200 System, iChemVELOCITY Automated Urine Chemistry SystemBeckman Coulter, Inc. · 2021 · 2 generations on1descendant
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−2K943592Chemstrip Mini UA Urine AnalyzerBoehringer Mannheim Corp.1994—
−1K983510Chemstrip 101 Urine AnalyzerBoehringer Mannheim Corp.1998—
0 (this device)K013783Aution Max AX-4280 Urinalysis SystemInternational Remote Imaging Systems2002—
+1K093098Aution Max Model AX-4030 Urinalysis SystemArkray, Inc.2009—
+1K101852Chem Velocity Automated Urine Chemistry System, Strips and Calchek KitIris International Inc., A Division of Iris Iris I201111
+2K171083iChemVELOCITY Automated Urine Chemistry SystemIris Diagnostics, A Division of Iris International, Inc.2017—
+1K030600Aution Jet AJ-4270 Urine AnalyzerInternational Remote Imaging Systems2003—
+2K210127iQ200 System, iChemVELOCITY Automated Urine Chemistry SystemBeckman Coulter, Inc.20216

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199510

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200310
200610
200910
201110
201310
201610
201710
202110
202310
202410
202510
FIG. 1 — Lineage of K013783, 1994–2025Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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
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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.

TypeNumberDeviceApplicantDecidedRecalls
*K946183Clinitek Atlas Automated Urine Chemistry Analyzer
Summary page 1
…Name: Urinalysis System Classification Name: Automated Urinalysis System 3. PREDICATE DEVICES e Clinitek Atlas Automated Urine Chemistry Analyzer, Bayer Corporation (K946183) Chemstrip® Super UA™ Automated Urine Analyzer, Boehringer Mannheim Corporation (K983510) 4. DEVICE DESCRIPTION The AUTION MAX…
Heraeus Kulzer, Inc.1995—
*K983510Chemstrip 101 Urine Analyzer
Summary page 1
…VICES e Clinitek Atlas Automated Urine Chemistry Analyzer, Bayer Corporation (K946183) Chemstrip® Super UA™ Automated Urine Analyzer, Boehringer Mannheim Corporation (K983510) 4. DEVICE DESCRIPTION The AUTION MAX Urinalysis System consists of an Analyzer, Sampler, and accessories. ARKRAY also offers a…
Boehringer Mannheim Corp.1998—

Also cleared against K946183: 1 other device →

What descends from it? (11)

See all 11

4 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K093098Aution Max Model AX-4030 Urinalysis SystemArkray, Inc.20094
K101852Chem Velocity Automated Urine Chemistry System, Strips and Calchek KitIris International Inc., A Division of Iris Iris I20113
K030600Aution Jet AJ-4270 Urine AnalyzerInternational Remote Imaging Systems20032
K193514AUTION MAX AX-4060 Urinalysis SystemArkray, Inc.20230

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 8 years and passes through 2 companies; a new generation was cleared every 4.0 years on median.
  • None of the 3 ancestors has a recall.
  • Of its descendants, K093098 (Arkray, Inc., 2009) has gone furthest, with 4 descendants of its own.
  • 1 other device also cites its predicate K946183.

How does its category compare?

All KQO devices

KQO Automated Urinalysis System: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · KQO

2in 2015

2007: 12009: 12010: 22011: 22013: 12014: 12015: 2
2007high 2 (2010) · low 0 (2008)2026

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

2010: 72011: 22013: 12016: 12019: 22021: 12026 (partial year): 2
2007high 7 (2010) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · KQO

12in 2025

2007: 12008: 42009: 92010: 32011: 82012: 152013: 922014: 1062015: 2382016: 3732017: 202018: 252019: 642020: 212021: 132022: 152023: 192024: 202025: 12
2007high 373 (2016) · low 1 (2007)2025

MAUDE reports naming product code KQO, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20071—01
20080—04
20091—09
20102—73
20112—28
20120—015
20131—192
20141—0106
20152—0238
20160—1373
20170—020
20180—025
20190—264
20200—021
20210—113
20220—015
20230—019
20240—020
20250—012
20260—2—

What is it indicated for?

The AUTION MAX AX-4280 Urinalysis System (AUTION MAX) is an automated urine analyzer intended for the in vitro measurement of the following analytes: glucose, protein, bilirubin, urobilinogen, pH, blood, ketones, nitrite, leukocytes, specific gravity, turbidity, and color. The AUTION MAX is intended for use only with AUTION Sticks 9EB multi-parameter test strips.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

Also cleared against K946183

1 other device cites the same predicate.

  • K030600Aution Jet AJ-4270 Urine AnalyzerInternational Remote Imaging Systems · 2003

More from International Remote Imaging Systems

3 FDA decisions under this applicant name. See the company

  • K030600Aution Jet AJ-4270 Urine AnalyzerInternational Remote Imaging Systems · 2003
  • K945913Irispec Urine Chemistry Control Part a and BInternational Remote Imaging Systems · 19952 recalls

Recent decisions in KQO

The KQO category page

  • K141874Uriscan OptimaYd Diagnostics Corp. · 2015
  • K142543Mission U120 Ultra Urine Analyzer, Mission Liquid Urine Controls, Mission Liquid Diptube Urine ControlACON Laboratories, Inc. · 2015
  • K140717Clinitek Novus; Automated Urine Chemistry Analyzer, 10 Urinalysis Cassette, Calibration KitSiemens Healthcare Diagnostics · 2014
  • K121456Aution Hybrid AU-4050 Fully Automated Integrated Urine Analyzer System; Uriflet S 9HA Urine Test Strips…Arkray, Inc. · 20131 recall
  • K102188Cybow Reader, Models 300 & 720DFI Co., Ltd. · 2011

https://510kreport.com/device/K013783 · printed Nov 5, 2026

Cite this page

510(k) Report. “K013783: Aution Max AX-4280 Urinalysis System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K013783

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026