Aution Hybrid Au-4050 Fully Automated Integrated Urine Analyzer System; Uriflet S 9HA Urine Test Strips; Aution Control

• • Terminated Z-1850-2019 FDA Class II ·initiated 3 May 2019

  This correction is being initiated due to a software issue which results in the possibility of incorrect patient information being assigned to sample results when the following rare combination of three specific events were to occur: 1) No measurement results are generated due to an error by a urine sediment measurement. 2) The instrument is shutdown incorrectly. 3) An item rack is used for subsequent sample measurements.

510(k) Number

K121456 ↗

FDA Product Code

KQO

Models / Variants

Aution Hybrid Au-4050 Fully Automated Integrated Urine Analyzer System

Uriflet S 9HA Urine Test Strips

Aution Control

Device Class

Class I

Regulation

21 CFR Part 862.2900

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

• AUTION MAX AX-4060 Urinalysis System

  Class II

  FDA 510(k) K193514 Active Cleared 13 Apr 2023

• Aution Eye AI-4510 Urine Particle Analysis System

  Class II

  FDA 510(k) K232416 Active Cleared 3 May 2024

• The Polymedco Spotchem Ex Glucose, Fructosamine and Ast Tests

  Class II

  FDA 510(k) K041427 Active Cleared 24 Nov 2004

• Spotchem Ii Calcium, Magnesium, and Blood Urea Nitrogen Tests

  Class II

  FDA 510(k) K050077 Active Cleared 15 Feb 2005

• Arkit HBA1C

  Class II

  FDA 510(k) K030553 Active Cleared 2 Sep 2003

• Polymedco Spotchem Ez Chemistry Analyzer

  Class I

  FDA 510(k) K040332 Active Cleared 16 Jun 2004

See all devices from Arkray, Inc. →