# K171521: DUS R-50S (Urine Chemistry system)

- Pathway: 510(k) (Traditional)
- Applicant: DFI Co., Ltd.
- Decided: Feb 16, 2018 after 268 days
- Product code: JIL (Method, Enzymatic, Glucose (Urinary, Non-Quantitative))
- Device class: 2
- Regulation: 21 CFR 862.1340
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K905396 (1991). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K091216: Clinitek Status+Analyzer and Clinitek Status Connect System, Models 1780, 1797, Siemens Healthcare Diagnostics (2009) Summary page 5.

## Indications for use
The DUS R-50S System provides a qualitative and semi-quantitative measurements for specific gravity, pH, leukocytes, nitrite, protein, glucose, ketone, urobilinogen, bilirubin, blood, microalbumin and creatinine in urine specimens. These measurements are used to aid in the diagnosis of metabolic disorders, kidney function anomalies, urinary tract infections and liver function. The system is intended for prescription, in vitro diagnostic use only. The DUS R-50S System consists of the following: DUS R-50S Analyzer DUS 10 Reagent Strips for urinalysis include test pads for leukocytes, nitrite, urobilinogen, protein, pH, blood, specific gravity, ketone(acetoacetic acid), bilirubin and glucose. DUS 2AC Reagent Strips for urinalysis include test pads for microalbumin and creatinine.

Source page: https://510kreport.com/device/K171521
Methodology: https://510kreport.com/methodology