MultiSure GK Link Blood Glucose and Ketone Monitoring System
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K201880 FDA 510(k)
- FDA Product Code
- NBW FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 862.1345 FDA 510(k)
- Regulation Number
- 862.1345 FDA 510(k)
- Advisory Committee
- Clinical Chemistry FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The MultiSure GK Link Blood Glucose and Ketone Monitoring System is a portable diagnostic device designed for the simultaneous measurement of blood glucose and ketone levels. Classified under clinical chemistry instrumentation, it provides quantitative results to support diabetes management and metabolic monitoring.
This system is intended for single-use, in-home or clinical settings, and requires a minimal blood sample of 0.5 µL for glucose testing, yielding results within 5 seconds. Supplied as a sterile, disposable device, it complies with FDA 510(k) clearance (K201880) and IVDD standards, ensuring regulatory adherence for diagnostic use.
Frequently asked questions
What types of settings can the MultiSure GK Link System be used in, and how does its single-use design benefit users?
The MultiSure GK Link Blood Glucose and Ketone Monitoring System is designed for both in-home and clinical use, offering flexibility for diabetes management and metabolic monitoring. Its single-use, disposable format ensures sterility and reduces the risk of cross-contamination, which is particularly important in clinical settings where multiple patients may be tested. For home users, this also eliminates the need for cleaning or sterilization between uses, simplifying the testing process.
How much blood is needed for a test, and how quickly can results be obtained with this device?
The MultiSure GK Link requires only a minimal blood sample of 0.5 µL for glucose testing, which is less invasive than many traditional glucose meters. Results for glucose are delivered within 5 seconds, making it efficient for quick monitoring. Ketone levels are also measured simultaneously, though the exact timeframe for ketone results isn’t specified in the data.
Is the device pre-sterilized, and what does this mean for its handling and storage?
Yes, the MultiSure GK Link is supplied as a sterile, disposable device, meaning it’s packaged in a way that maintains sterility until first use. This eliminates the need for additional sterilization procedures before testing. For storage, it should be kept in its original packaging until ready for use to preserve sterility, and any unused units should be stored according to manufacturer guidelines to prevent contamination or degradation.
What regulatory pathways has this device undergone, and what does that mean for its use in clinical or home settings?
The MultiSure GK Link has undergone FDA 510(k) clearance (K201880) and complies with In Vitro Diagnostic Device (IVDD) standards, confirming its safety and performance for diagnostic use. This regulatory approval ensures the device meets U.S. and EU standards for accuracy, reliability, and clinical chemistry instrumentation. Clinicians and home users can trust its compliance with these rigorous standards for monitoring blood glucose and ketone levels.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: APEXBIO MULTISURE GK LINK MTM309 USER MANUAL Pdf Download, ApexBio MultiSure GK Link Blood Glucose and Ketone Monitoring System ..., MultiSure GK Glucose and Ketone Monitoring System | APEX BIOTECHNOLOGY ..., PDF Blood Glucose and Ketone Monitoring System - apexbio.com
Authorization Coverage (2 countries)
Regulatory Authorizations
IVDD
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | IVDD | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K201880 | Class II | Active |
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Manufacturer
- Manufacturer
- Apex Biotechnology Corp.
Sources (2)
- FDA 510(k) K201880 24 fields · synced Oct 6, 2026
- EUDAMED 1 fields · synced May 19, 2026