DUS 2GP Reagent Strips, DUS 5 Reagent Strips, DUS 10 Reagent Strips

K181024 · DFI Co., Ltd. · JIL · May 23, 2018 · Clinical Chemistry

Device Facts

• Record ID: K181024
• Device Name: DUS 2GP Reagent Strips, DUS 5 Reagent Strips, DUS 10 Reagent Strips
• Applicant: DFI Co., Ltd.
• Product Code: JIL · Clinical Chemistry
• Decision Date: May 23, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1340
• Device Class: Class 2
• Attributes: Pediatric

Indications for Use

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 speciments are used to aid in the diagnosis of metabolic disorders, kidney function anomalies, urinary tract infections and liver function.

Device Story

DUS Series (2GP, 5, 10) are urine reagent strips with multiple pads affixed to plastic strips; pads react with urine analytes to produce visible color changes. Used in clinical settings by medical technicians; results obtained by visual comparison against a color chart on the container. Provides qualitative and semiquantitative measurements for leukocytes, nitrite, urobilinogen, protein, pH, blood, specific gravity, ketone, bilirubin, and glucose. Results aid clinicians in diagnosing metabolic disorders, kidney function anomalies, urinary tract infections, and liver function. Benefits include rapid, point-of-care screening for various physiological conditions.

Clinical Evidence

Bench testing only. Method comparison study conducted at three clinical sites with 867 fresh urine samples compared against the predicate (Multistix 10SG). Precision/reproducibility tested per CLSI EP5-A3 using 90 replicates per level. Analytical specificity and interference studies evaluated potential cross-reactivity with various drugs and substances. Results showed high agreement (exact or within one color block) across all analytes.

Technological Characteristics

Plastic strips with reagent pads for colorimetric analysis. Analyte detection via chemical reaction producing visible color change. Dimensions/form factor: standard reagent strip. Connectivity: none (visual read). Sterilization: not specified. Software: none.

Indications for Use

Indicated for prescription, in vitro diagnostic use in patients requiring urine analysis for metabolic disorders, kidney function anomalies, urinary tract infections, or liver function. Applicable to all ages and genders.

Regulatory Classification

Identification

A urinary glucose (nonquantitative) test system is a device intended to measure glucosuria (glucose in urine). Urinary glucose (nonquantitative) measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, hypoglycemia, and hyperglycemia.

Submission Summary (Full Text)

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# 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION
## TRIAGE-QUICK REVIEW DECISION SUMMARY

510(k) Number: k181024

This 510(k) was reviewed under OIR’s Triage-Quick Review Program. This program represents an internal workload management tool intended to reduce internal FDA review resources for 510(k) applications that are of good quality upon receipt by FDA.

The information in the 510(k) is complete and supports a substantial equivalence (SE) determination. Please refer to the applicant’s 510(k) summary for a summary of the information that supports this SE determination.