# K181024: DUS 2GP Reagent Strips, DUS 5 Reagent Strips, DUS 10 Reagent Strips

- Pathway: 510(k) (Traditional)
- Applicant: DFI Co., Ltd.
- Decided: May 23, 2018 after 35 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: 1 generation back to K992257 (1999). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K992257: New Multiples Reagent Strips, Bayer Corp. (1999) Summary page 5.

## Indications for use
DUS 2GP Reagent Strips, DUS 5 Reagent Strips, DUS 10 Reagent Strips This device is intended for the in vitro measurement of the following in urine: Leukocyte, Nitrite, Urobilinogen, Protein, pH, Blood, Specific gravity, Ketone, Bilirubin, Glucose. These strips are intended for prescription, in vitro diagnostic use only and they are visually read. DUS 2GP reagent strips provide qualitative and semiquantitative measurements for protein, and glucose in urine specimens. Test results may provide information regarding the status of carbohydrate metabolism and kidney function. DUS 5 reagent strips provide qualitative and semiquantitative measurements for leukocytes, nitrite, blood, protein, and glucose in urine specimens. These measurements are used to aid in the diagnosis of metabolic disorders, kidney function anomalies and urinary tract infections. DUS 10 reagent strips provide qualitative and semiquantitative measurements for specific gravity, pH, leukocytes, nitrite, protein, glucose, ketone, urobilinogen, bilirubin and blood in urine specimens. These measurements are used to aid in the diagnosis of metabolic disorders, kidney function anomalies, urinary tract infections and liver function.

Source page: https://510kreport.com/device/K181024
Methodology: https://510kreport.com/methodology