# K121456: Aution Hybrid AU-4050 Fully Automated Integrated Urine Analyzer System; Uriflet S 9HA Urine Test Strips; Aution Control

- Pathway: 510(k) (Traditional)
- Applicant: Arkray, Inc.
- Decided: Feb 1, 2013 after 261 days
- Product code: KQO (Automated Urinalysis System)
- Device class: 1
- Regulation: 21 CFR 862.2900
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K900484 (1990). 10 ancestors in all.
No later device cites it as a predicate yet.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K093098: Aution Max Model AX-4030 Urinalysis System, Arkray, Inc. (2009) Summary page 2.
- K080887: Sysmex UF-1000I, Automated Urine Particle Analyzer with Urinalysis Wam Software, Sysmex America, Inc. (2008) Summary page 2.
- K070910: Sysmex Model UF1000I, Sysmex America, Inc. (2007) Summary page 2.

## Recalls of this device
- May 3, 2019 · Class II · Z-1850-2019: 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 thr

## Indications for use
AUTION HYBRID T M AU-4050 Fully Automated Integrated Urine Analyzer System The AUTION HYBRID T M AU-4050 Fully Automated Integrated Urine Analyzer System contains a test strip chemistry urine analyzer and a flow cytometry urine particle analyzer together in a single integrated device. The test strip chemistry module (OHM) is an automated urine analyzer intended for the in vitro measurement of the following parameters: glucose, protein, bilirubin, urobilinogen, pH, blood, ketones, nitrite, leukocytes, specific gravity, turbidity, and color. The chemistry module is intended for use with the Uriflet TM S 9HA multi-parameter urine chemistry test strips. The flow cytometry module (FCM) is an automated urine particle analyzer intended to analyze the following parameters in urine samples: Red Blood Cells, White Blood Cells, Epithelial Cells, Casts, and Bacteria and flags the presence of the following: Pathologic Casts, Crystals, Sperm, Small Round Cells, Yeast Like Cells, and Mucus. The AUTION HYBRID AU-4050 is intended for in vitro diagnostic use in screening patient populations found in clinical laboratories. Uriflet TM S 9HA Urine Test Strips Uriflet TM S 9HA is a urinalysis test strip with reagent pads for the determination of Glucose, Protein, Bilirubin, Urobilinogen, pH, Blood, Ketones, Nitrite, and Leukocytes. Uriflet S 9HA is for use with the AUTION HYBRID AU-4050 only. AUTION TM Control Solution The AUTION Control Solution is intended for in vitro diagnostic use only for performing quality control procedures with the AUTION HYBRID AUA4050 flow cytometry module.

Source page: https://510kreport.com/device/K121456
Methodology: https://510kreport.com/methodology