Aution Eye AI-4510 Urine Particle Analysis System

510(k) Number

K232416 ↗

FDA Product Code

LKM

Device Class

Class II

Regulation

21 CFR Part 864.5200

Advisory Committee

Hematology

FDA Decision

SESE Substantially Equivalent

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See all devices from Arkray, Inc. →

• What is the Aution Eye AI-4510 Urine Particle Analysis System used for?

  The Aution Eye AI-4510 is designed for automated classification of urine sediment particles, specifically identifying cellular elements like red blood cells, white blood cells, and epithelial cells, as well as crystalline structures. This reduces reliance on manual microscopic examination while improving diagnostic accuracy and efficiency in hematology workflows.

• How is the Aution Eye AI-4510 supplied and what are its sterility and reuse details?

  The system is supplied as a standalone device intended for clinical laboratory use. The sample analysis components are non-sterile and intended for single-use, while the core instrument itself is reusable. This design balances convenience with infection control protocols.

• Can the Aution Eye AI-4510 integrate with other laboratory systems?

  Yes, the Aution Eye AI-4510 is compatible with standard laboratory environments and can integrate with complementary systems like the AUTION MAX AX-4060. This enhances workflow efficiency by enabling seamless data exchange and streamlined urine analysis processes.

• What regulatory clearance does the Aution Eye AI-4510 hold?

  The device has received FDA 510(k) clearance and is classified as a Class II medical device under FDA regulations. This clearance confirms its substantial equivalence to a predicate device, ensuring it meets established safety and performance standards for urine particle analysis.

• What storage and maintenance requirements should be followed for the Aution Eye AI-4510?

  Storage and maintenance instructions are detailed in the manufacturer’s provided documentation. Proper handling ensures optimal performance and longevity of the reusable instrument components. Follow Arkray’s guidelines to maintain calibration, cleanliness, and functionality for reliable urine sediment analysis.