Urine Chemistry Analyzer UR-50
by Ind Diagnostic, Inc. 510(k)
Active
510(k) K063390
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK063390 | Date1 Mar 2007 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- JIL
- Device Class
- Class II
- Regulation
- 21 CFR Part 862.1340
- Advisory Committee
- Clinical Chemistry
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 19 Sep 2026
The Urine Chemistry Analyzer UR-50 is a Method, Enzymatic, Glucose (Urinary, Non-Quantitative) device, classified as a Class II medical instrument. It automates the analysis of urine samples using IND Urinalysis Reagent Strips to detect and measure multiple analytes, including glucose, bilirubin, ketone bodies, blood, protein, urobilinogen, nitrite, leukocytes, pH, and specific gravity. Designed for clinical chemistry applications, it provides rapid, semi-quantitative results to aid in diagnostic evaluations.
The UR-50 is intended for use in clinical laboratory settings by trained personnel. It operates as a standalone analyzer, requiring compatible reagent strips for functionality. The device is not described as sterile or single-use; its regulatory submission (FDA 510(k) K063390) confirms compliance under 21 CFR 862.1340 for urine chemistry testing. No MRI safety or reusable specifications are noted in the available data.
Other devices from Ind Diagnostic, Inc.
Questions
AI-generated answers, 19 Sep 2026
What types of analytes does the Urine Chemistry Analyzer UR-50 detect in urine samples?
The UR-50 detects multiple analytes in urine samples, including glucose, bilirubin, ketone bodies, blood, protein, urobilinogen, nitrite, leukocytes, pH, and specific gravity. It uses IND Urinalysis Reagent Strips to provide rapid, semi-quantitative results for clinical chemistry applications.
Is the Urine Chemistry Analyzer UR-50 designed for single-use or reusable applications?
The UR-50 is not described as a single-use device. Based on the available data, it is intended for reusable use in clinical laboratory settings by trained personnel, though the specific reuse guidelines (e.g., cleaning, sterilization) are not detailed in the provided information.
What is the intended clinical setting for the Urine Chemistry Analyzer UR-50?
The UR-50 is designed exclusively for use in clinical laboratory settings, where trained personnel can operate it as a standalone analyzer. It is not intended for point-of-care or home use, nor does it include any features for non-laboratory environments.
How is the Urine Chemistry Analyzer UR-50 powered or operated, and what supplies are required?
The UR-50 operates as a standalone analyzer, meaning it does not require external connections (like a computer) for basic functionality. However, it requires compatible IND Urinalysis Reagent Strips to perform urine chemistry tests. No details on power source (e.g., battery, mains) are provided in the data, but its classification as a Class II device suggests it likely uses standard electrical power.
What regulatory pathway was followed for the FDA clearance of the Urine Chemistry Analyzer UR-50?
The UR-50 received FDA clearance through a Traditional 510(k) pathway (K063390) under the Clinical Chemistry advisory committee (CH). It was determined to be substantially equivalent to a predicate device and complies with 21 CFR 862.1340 for urine chemistry testing. The submission was filed in 2006 and cleared in 2007.