Uropaper Eiken 6B
510(k) K932368
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK932368 | Date13 Jan 1994 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
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, 1 Oct 2026
The Uropaper Eiken 6B is a urinary non-quantitative enzymatic glucose test strip, designed for qualitative detection of glucose in urine samples. This device falls under the classification of 'Method, Enzymatic, Glucose (Urinary, Non-Quantitative)' and is intended for use in clinical chemistry settings. It employs enzymatic reactions to identify the presence of glucose without quantifying its concentration, providing a simple yes/no result.
The Uropaper Eiken 6B is supplied as a single-use diagnostic test strip and is regulated under FDA 510(k) clearance (K932368) with a classification product code of JIL. It is intended for use in non-sterile settings, such as clinical laboratories or physician offices, and requires no special storage conditions beyond those recommended by the manufacturer. The device is classified as Class II under FDA regulation 862.1340, ensuring compliance with established safety and performance standards for diagnostic test strips.
Other devices from Tanabe U.S.A., Inc.
Questions
AI-generated answers, 1 Oct 2026
What is the Uropaper Eiken 6B used for?
The Uropaper Eiken 6B is designed for qualitative detection of glucose in urine samples. It uses enzymatic reactions to determine whether glucose is present or absent, providing a straightforward yes/no result. This makes it useful in clinical chemistry settings for initial screening of urinary glucose levels, such as in diabetes management or diagnostic evaluations.
Is the Uropaper Eiken 6B intended for sterile use?
No, the Uropaper Eiken 6B is specifically intended for use in non-sterile settings. It is supplied as a single-use diagnostic test strip and does not require sterile conditions for its application, making it suitable for clinical laboratories or physician offices where sterility is not a primary concern for this type of test.
How is the Uropaper Eiken 6B supplied, and is it reusable?
The Uropaper Eiken 6B is supplied as a single-use diagnostic test strip. Each strip is intended for one-time use only, ensuring accuracy and reliability for a single urine glucose test. Reusing the strip is not recommended, as it could compromise test results and potentially introduce contamination.
What storage conditions are required for the Uropaper Eiken 6B?
The Uropaper Eiken 6B does not require special storage conditions beyond those recommended by the manufacturer. It should be stored in a dry place, protected from direct sunlight and extreme temperatures, to maintain its performance and accuracy. Always follow the manufacturer’s guidelines for optimal storage to ensure reliable test results.
What regulatory pathway does the Uropaper Eiken 6B follow?
The Uropaper Eiken 6B is regulated under the FDA’s 510(k) clearance pathway, specifically with clearance number K932368. It is classified as a Class II device under FDA regulation 862.1340, which ensures it meets established safety and performance standards for enzymatic urinary glucose test strips. This classification reflects its intended use in clinical chemistry for qualitative glucose detection.