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Uropaper Eiken GK

by Syn-Kit, Inc. 510(k)

Active United States

510(k) K843758

Overview

The Uropaper Eiken GK is a non-quantitative enzymatic method for detecting glucose in urinary samples. Classified as a clinical chemistry device, it employs enzymatic reactions to identify the presence of glucose without quantifying its concentration, aiding in the preliminary assessment of urinary glucose levels.

This single-use diagnostic test is supplied as a strip-based format and is intended for in vitro use in clinical laboratory settings. It is regulated under FDA 510(k) clearance (K843758) and falls under the classification product code JIL, adhering to regulation 862.1340. Storage and handling instructions are not specified in the data, but standard laboratory practices for urinary test strips apply.

AI-generated from registry data, 19 Sep 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK843758 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 primary purpose of the Uropaper Eiken GK, and how does it differ from quantitative glucose tests?

    The Uropaper Eiken GK is designed as a non-quantitative enzymatic test strip for detecting the presence of glucose in urinary samples, not for measuring exact concentrations. Unlike quantitative tests, it provides a preliminary indication of whether glucose is present in urine, aiding in initial screening rather than precise diagnostic quantification. This makes it useful for rapid, qualitative assessments in clinical laboratory settings.

  • Is the Uropaper Eiken GK intended for single-use or repeated testing, and how is it supplied?

    The Uropaper Eiken GK is explicitly labeled as a single-use diagnostic test strip. It is supplied in a strip-based format, meaning each strip is intended for one-time use with a urinary sample. This design ensures accuracy and prevents cross-contamination between tests.

  • What type of regulatory clearance does the Uropaper Eiken GK hold, and under which FDA classification is it categorized?

    The Uropaper Eiken GK holds FDA 510(k) clearance under the classification product code JIL, which falls under the broader regulation 862.1340. It is classified as a clinical chemistry device and was determined to be substantially equivalent to a predicate device through a traditional 510(k) review process, as indicated by the decision code SESE.

  • Are there multiple models or sizes available for the Uropaper Eiken GK, or is it a standardized test strip?

    The provided data does not specify distinct models or sizes for the Uropaper Eiken GK, suggesting it is likely supplied as a standardized strip format without variations. The focus is on its non-quantitative enzymatic method for glucose detection in urine, implying uniformity in design and function across its intended use cases.