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Uropaper Eiken 6B

by Syn-Kit, Inc. 510(k)

Active United States

510(k) K843755

Overview

The Uropaper Eiken 6B is an enzymatic, non-quantitative urinary glucose test strip, classified under the device type 'Method, Enzymatic, Glucose (Urinary, Non-Quantitative)'. It is designed for the qualitative detection of glucose in urine samples, utilizing enzymatic chemistry to provide a visual indication of presence without quantifying the concentration.

This single-use diagnostic device is supplied as a strip intended for in vitro clinical chemistry use, specifically within the field of urinalysis. It is regulated under FDA 510(k) clearance (K843755) and falls under product code JIL, adhering to regulation number 862.1340. The device is not intended for MRI use and requires proper storage to maintain its integrity until use. No information regarding sterility or reusable components is provided in the specifications.

AI-generated from registry data, 1 Oct 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK843755 Date18 Dec 1984ClearedStatusActive

Coverage

1 jurisdiction

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

510(k)

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

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Questions

  • What is the Uropaper Eiken 6B used for?

    The Uropaper Eiken 6B is an enzymatic urinary glucose test strip designed for the qualitative detection of glucose in urine samples. It uses enzymatic chemistry to provide a visual indication of whether glucose is present, but it does not measure the exact concentration. This makes it useful for screening purposes in clinical chemistry, particularly in urinalysis.

  • How is the Uropaper Eiken 6B supplied?

    The Uropaper Eiken 6B is supplied as individual, single-use test strips. Each strip is intended for one-time use in in vitro clinical chemistry testing, ensuring accuracy and preventing cross-contamination between samples. The packaging is designed to maintain the integrity of the strips until use.

  • Is the Uropaper Eiken 6B sterile?

    The provided specifications do not explicitly state whether the Uropaper Eiken 6B is sterile. For clinical use, it is important to confirm sterility requirements with the manufacturer or consult their instructions for use. If sterility is critical for your application, verify this detail before use.

  • Can the Uropaper Eiken 6B be reused?

    No, the Uropaper Eiken 6B is explicitly designed as a single-use device. Reusing test strips could compromise accuracy, introduce contamination, and potentially lead to unreliable results. Always use a new strip for each urine sample to ensure valid and safe testing.

  • How should the Uropaper Eiken 6B be stored?

    Proper storage is essential to maintain the integrity and performance of the Uropaper Eiken 6B. Store the strips in a cool, dry place, away from direct sunlight, moisture, and extreme temperatures. Follow the manufacturer’s guidelines for storage conditions to ensure the test strips remain effective until use. Avoid storing in environments where they could be exposed to chemicals or contaminants.