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Sejoy Blood Glucose Monitoring System; Sejoy Advance Link Blood Glucose Monitoring System

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K240640

by Sejoy Biomedical Co., Ltd.

Identifiers

510(k) Number
K240640 FDA 510(k)
FDA Product Code
NBW FDA 510(k)
Models / Variants
Sejoy Blood Glucose Monitoring System FDA 510(k)EUDAMED
Sejoy Advance Link Blood Glucose Monitoring System FDA 510(k)EUDAMED

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 Sejoy Blood Glucose Monitoring System is an in-vitro diagnostic device classified as a blood glucose test system. It is designed for self-testing outside the body to measure blood glucose levels, aiding individuals with diabetes in monitoring their condition at home.

This system is supplied as a single-use or reusable device, depending on the components, and is intended for over-the-counter use under FDA 510(k) clearance (K240640) and IVDD compliance. It operates in clinical chemistry settings and is regulated under product code NBW, with a decision of Substantially Equivalent (SESE) by the FDA. Storage and handling follow standard in-vitro diagnostic protocols as specified by the manufacturer.

Frequently asked questions

What types of users can use the Sejoy Blood Glucose Monitoring System, and how is it primarily intended to be used?

The Sejoy Blood Glucose Monitoring System is designed for self-testing outside the clinical setting, making it suitable for individuals with diabetes who monitor their blood glucose levels at home. It is intended for over-the-counter use, allowing users to conveniently check their glucose levels without needing a healthcare provider’s assistance. The system operates as an in-vitro diagnostic device, adhering to standard protocols for home glucose monitoring.

Is the Sejoy Blood Glucose Monitoring System single-use or reusable, and how does this affect its practicality?

The Sejoy Blood Glucose Monitoring System can be supplied as either a single-use or reusable device, depending on the specific components involved. This flexibility allows users to choose between disposable test strips or meters that can be reused with compatible consumables, balancing convenience and cost. Single-use components ensure hygiene and reduce cross-contamination risks, while reusable options may offer cost savings for frequent users.

What regulatory pathways does the Sejoy Blood Glucose Monitoring System follow, and what does this mean for its use?

The Sejoy Blood Glucose Monitoring System is regulated under the FDA’s 510(k) clearance pathway (K240640) and complies with the In Vitro Diagnostic Device Directive (IVDD). The FDA classified it as Substantially Equivalent (SESE) under product code NBW, meaning it meets the same performance standards as existing approved devices. This ensures its safety, effectiveness, and reliability for home blood glucose monitoring, as overseen by the Clinical Chemistry advisory committee.

How should the Sejoy Blood Glucose Monitoring System be stored, and what precautions should be taken?

Storage and handling of the Sejoy Blood Glucose Monitoring System follow standard in-vitro diagnostic protocols as specified by the manufacturer. While exact storage conditions aren’t detailed here, typical guidelines for glucose monitoring systems include keeping the device in a cool, dry place away from direct sunlight and extreme temperatures. Single-use components should be stored according to their expiration dates to maintain accuracy and reliability. Always refer to the manufacturer’s instructions for precise storage guidelines.

Are there different models or sizes available for the Sejoy Blood Glucose Monitoring System, and how might this affect my choice?

The system includes two primary models: the Sejoy Blood Glucose Monitoring System and the Sejoy Advance Link Blood Glucose Monitoring System. While the exact differences in features or sizes aren’t specified here, the

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: Sejoy Blood Glucose Monitoring System; Sejoy Advance Link Blood Glucose ..., Sejoy Blood Glucose Monitoring System; Sejoy Advance Link Blood Glucose ..., Sejoy - Home in vitro diagnostic products, blood glucose meter, Lipid ..., Sejoy Blood Glucose Monitoring System; Sejoy Advance Link Blood Glucose ...

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

IVDD

United States Active

FDA_510K

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Manufacturer

Manufacturer
Sejoy Biomedical Co., Ltd.

Sources (2)

  • FDA 510(k) K240640 24 fields · synced Oct 6, 2026
  • EUDAMED 1 fields · synced May 19, 2026