AUTION EYE AI-4510 Urine Particle Analysis
Overview
The AUTION EYE AI-4510 Urine Particle Analysis System is a fully automated urine particle analyzer designed for in vitro diagnostic use. It utilizes a flow cell digital imaging method to capture images of formed elements in urine samples. The system then automatically classifies these images into 12 categories of formed elements based on their size and shape using a proprietary algorithm, which is based on neural network technology. This automation streamlines the urine analysis process, aiming to reduce manual microscopy and improve efficiency in laboratory operations.
The analyzer can be used as a standalone unit or connected with the AUTION MAX AX-4060 urine chemistry analyzer for a comprehensive urinalysis system with a compact footprint. It provides quantitative measurements for red blood cells (RBC), white blood cells (WBC), and squamous epithelial cells (SQEC), semi-quantitative measurements for bacteria (BACT) and crystals (CRYS), and qualitative measurements for 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. The system also includes an “Atlas Image Collection” for easier identification of particle images and can be used as a valuable training tool.
Reviewed by Pouyan Golshani, MD — Interventional Radiologist
Use Cases
- Streamlining urine sediment testing workflow in clinical laboratories
- Reducing the rate of manual microscopy for urine samples
- Assisting in the diagnosis and monitoring of kidney and urinary tract diseases
- Standardization of urine particle determination and staff education in laboratories
- Efficient analysis of urine samples by combining with urine chemistry analyzers
- Identifying early-stage renal disease through accurate particle analysis
What Physicians Need to Know
The AUTION EYE AI-4510 provides rapid, AI-assisted urine particle analysis, reducing the need for manual microscopy in routine cases. Physicians should note its capability for quantitative, semi-quantitative, and qualitative assessment of key urine sediment elements. The cross-check function with urine chemistry results enhances diagnostic confidence. While the AI offers initial classification, a trained technologist's review of flagged specimens and images remains crucial for definitive diagnosis, especially for complex cases or discrepancies. The system's ability to identify bacteria and yeast can aid in the initial screening for UTIs, but confirmation with bacterial cultures may still be necessary for precise identification and susceptibility testing. Leveraging the 'Atlas image collection' and custom image additions can standardize interpretation across the lab.
The AUTION EYE AI-4510 offers seamless integration capabilities primarily through Ethernet and RS-232C, allowing connection to Laboratory Information Systems (LIS) for data transfer. Its direct connectivity with ARKRAY's AUTION MAX AX-4060 urine chemistry analyzer creates a streamlined, compact urinalysis workstation, enabling comprehensive chemical and sediment analysis from a single sample. This integrated workflow facilitates cross-referencing of results, improving diagnostic efficiency and reliability.
Details
| Category | Lab & Diagnostics, Pathology AI |
| Pricing | Contact-for-pricing |
| Deployment | On-premise |
| Compliance | |
| BAA Available | Unknown AI-estimated |
| HIPAA Compliant | Unknown AI-estimated |
| FDA Status |
1 AI-estimated The AUTION EYE AI-4510 Urine Particle Analysis System received 510(k) clearance (K232416) from the FDA on May 3, 2024. It is intended for in vitro diagnostic use for quantitative, semi-quantitative, and qualitative measurements of various formed elements in urine samples. |
| Integrations | |
| EHR | Not specified |
| Specialties | Laboratory Medicine, Nephrology, Urology |
What the Web Says
The ARKRAY AUTION EYE AI-4510 is a fully automated urine particle analyzer designed to streamline urine analysis by classifying particles using a proprietary algorithm and digital imaging. It aims to reduce manual workload and improve accuracy in detecting various urine particles. The system has shown desirable imprecision, linearity, and comparability to visual microscopy for several particle types, with improved differentiation of urinary crystals compared to previous digital cuvette imaging.
Overall: MixedStrengths
- Automated classification of 12 particle types and 28 subcategories, saving time in urine sediment analysis.
- High agreement with visual microscopy for RBC, WBC, SEC, and crystals.
- Desirable imprecision, linearity, and low carry-over.
- Improved differentiation of urinary crystals compared to previous digital cuvette imaging.
- User-friendly interface with an easy-to-see configuration and intuitive operations.
- Compact design, especially when connected with the AUTION MAX AX-4060.
Limitations
- Performance of bacteria counting needs further confirmation against urine bacterial cultures.
- Identification of kidney damage is recommended to be improved by using user-defined review rules.
- Some Reddit users express frustration with frequent issues and breakdowns, preferring older models.
- All instrument analyte image decisions should be reviewed and reclassified as necessary by a trained technologist.
Based on reviews from: HELDA - University of Helsinki, PubMed, Semantic Scholar, CiteDrive, ARKRAY USA, Aution Portal, Pathology In Practice, YouTube, FDA 510(k) | Innolitics, accessdata.fda.gov, Reddit
Last updated: 2026-07-20
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