Hematology · 510(k) · 2024
AUTION EYE AI-4510 Urine Particle Analysis System
Arkray Inc.. Cleared by FDA on 3 May 2024 under submission K232416, product code LKM (counter, urine particle). What FDA's record says, in FDA's words.
Device record · K232416
- Device. AUTION EYE AI-4510 Urine Particle Analysis SystemDEVICE
- Company. Arkray Inc. (JP)COMPANY
- Decision. 3 May 2024, 510(k), substantially equivalent (traditional review); received 11 August 2023DECISION
- Panel. HematologyPANEL
- Product code. LKM, Counter, Urine ParticleCODE
- Regulation. 21 CFR 864.5200, Class IIREG
- Source. FDA database entry · decision document (23 pages)SOURCE
Retrieved · the fields above are FDA's; the statement below was copied from the decision document on that day.
What FDA cleared it for
The Indications for Use statement, verbatim, from the decision document.
AUTION EYE AI-4510 Urine Particle Analysis System is a fully automated urine particle analyzer for in vitro diagnostic use. AUTION EYE AI-4510 is intended for the quantitative measurement of red blood cells (RBC), white blood cells (WBC) and squamous epithelial cells (SQEC), the semi-quantitative measurement of bacteria (BACT) and crystals (CRYS) and the qualitative measurement of white blood cell clumps (WBCC), non-squamous epithelial cells (NSE), hyaline casts (HYAL), non-hyaline casts (NHC), yeast (YST), mucus (MUCS) and sperm (SPRM) in urine samples. A trained operator can set criteria for flagging specimens. All instrument analyte image decisions should be reviewed and reclassified as necessary by a trained technologist. The AUTION EYE AI-4510 analyzer can be used as a standalone unit or combined with an AUTION MAX AX-4060 urine chemistry analyzer.
What the statement says
Pattern matches on the Indications for Use text. Each line is a fact that the text contains the words, not a finding about the device.
- Mentionsmeasurement or quantification
- Mentionsa diagnostic claim
Adverse-event reports in MAUDE, by product code
As of , MAUDE held 14 reports filed against devices carrying product code LKM. That code is shared by every device of this type, not this device alone, and MAUDE reports are submitted by manufacturers, facilities and the public without FDA verification. The latest reports, in the reporter’s words:
7 January 2026 · Malfunction · COBAS U 701 MICROSCOPY ANALYZER · ROCHE DIAGNOSTICS · report 1823260-2026-00081
THE INITIAL REPORTER RECEIVED QUESTIONABLE BACTERIAL COUNT RESULTS FROM MULTIPLE URINE PATIENT SAMPLES TESTED ON THE COBAS U 701 MICROSCOPY ANALYZER. THE PATIENT'S BACTERIAL COUNT RESULTS FROM THE ANALYZER WERE NEGATIVE AND WERE DEEMED FALSE NEGATIVES. THE IMAGES OF THE PATIENT SAMPLES INDICATE THE PRESENCE OF BACTERIA.
23 July 2021 · Injury · UF-5000 FULLY AUTOMATED URINE PARTICLE ANALYZER · SYSMEX CORPORATION, I SQUARE · report 1000515253-2021-00013
FALSE NEGATIVE RESULTS WERE INTERMITTENTLY GENERATED FOR THE RED BLOOD CELL (RBC), CAST (CAST), AND CRYSTAL (X'TAL) PARAMETERS ON MULTIPLE URINE SAMPLES FROM MULTIPLE PATIENTS. ERRONEOUS RESULTS WERE REPORTED. ASSESSMENT OF ADVERSE EVENTS IS PENDING WITH THE REPORTER.
10 August 2020 · Injury · UF-5000 · SYSMEX CORPORATION, I SQUARE · report 1000515253-2020-00022
A USER IN THE (B)(6) REPORTED A URINE CULTURE WAS DELAYED DUE TO FALSE LOW WHITE BLOOD CELL (WBC) AND BACTERIA (BACT) RESULTS. THE SAMPLE WAS ANALYZED, AND LOW WBC AND BACT RESULTS WERE GENERATED. THE RESULTS WERE RELEASED TO THE LABORATORY INFORMATION SYSTEM (LIS). THE NEXT DAY, THE USER REPORTED WBC QUALITY CONTROL (QC) WAS RECOVERING LOW OUT OF RANGE. DURING INVESTIGATION, IT WAS FOUND THE UF-CELLPACK CR REAGENT HAD INADVERTENTLY BEEN EMPTIED AND FILLED WITH DEIONIZED WATER ON ALL ANALYZERS […]
31 January 2020 · Injury · UF-5000 FULLY AUTOMATED URINE PARTICLE ANALYZER · SYSMEX CORPORATION, I SQUARE · report 1000515253-2020-00003
AN OPERATOR IN DENMARK ALLEGED A CEREBROSPINAL FLUID (CSF) SAMPLE WAS ANALYZED AND GENERATED FALSELY ELEVATED POLYMORPHONUCLEAR LEUKOCYTES (PMN) AND FALSELY DECREASED MONONUCLEAR CELLS (MN). THERE WERE NO ERROR MESSAGES OR FLAGS WITH THE RESULTS. THESE RESULTS WERE NOT VERIFIED WITH MICROSCOPIC EVALUATION. DUE TO DUE TO THE PATIENT'S CLINICAL SIGNS AND SYMPTOMS AND RESULTS FROM THE CSF SAMPLE, THE PATIENT RECEIVED ANTIBIOTICS AND ANTI-VIRAL TREATMENT BEGINNING ON (B)(6) 2020. ADDITIONAL TESTS […]
13 June 2019 · Malfunction · SYSMEX UF-5000 FULLY AUTOMATED URINE PARTICLE ANALYZER · SYSMEX CORPORATION, I SQUARE · report 1000515253-2019-00014
IN (B)(6), THE USER OF A SYSMEX UF-5000 AUTOMATED URINE PARTICLE ANALYZER WITH A CV-11, URINE SAMPLE TRANSPORTATION UNIT, SERIAL NUMBER (SN) (B)(4), REPORTED SPARKS, SMOKE AND A BURNING ODOR COMING FROM THE CV-11 FOLLOWING A SPILL FROM A RACK OF URINE SAMPLES. THE USER REPORTED THAT THE CV-11 HAD CEASED OPERATION UNEXPECTEDLY, PROMPTING A RE-INITIALIZATION. UPON RE-INITIALIZATION, THE SAMPLE RACK WAS PUSHED TOWARDS THE LEFT RACK POOL AREA THAT COLLECTS SAMPLES AFTER ANALYSIS AND TIPPED OVER, […]
Where this fits
This page is a record, not medical advice and not a safety rating. It copies FDA's fields and FDA's statement, and lists what the statement's text mentions. Read the labeling before relying on any of it.
More devices under product code LKM, in Hematology, or cleared in 2024. The whole record is at FDA AI-enabled medical devices.
A device's authorized use is a sentence the record can be read against. What Apodicta does on a medical record is that reading: every line of a note, a claim or a report proved to its source or held, before it renders.