Dario LC Blood Glucose Monitoring System
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K172723 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 Dario LC Blood Glucose Monitoring System is a portable, smartphone-enabled device designed for continuous blood glucose monitoring in individuals with diabetes. Classified under the product code NBW, it integrates a compact meter with an integrated lancing device and test strips, enabling convenient self-monitoring of blood glucose levels. The system leverages mobile connectivity to transmit results directly to a paired smartphone, facilitating real-time tracking and management of glucose trends. Its design prioritises ease of use and accessibility for on-the-go monitoring.
The Dario LC is supplied as a single-use or reusable system, depending on the components, and is intended for home use. It operates outside MRI environments and includes models with Lightning (1021-04) and USB-C (1021-06) connectors for smartphone compatibility. Storage requirements are standard for medical devices, and the system holds FDA 510(k) clearance under the Clinical Chemistry advisory committee, with a decision date of March 23, 2018. No specific sterility claims are stated, and regulatory compliance is tied to the submitted 510(k) submission (K172723)
Frequently asked questions
What is the Dario LC Blood Glucose Monitoring System used for?
The Dario LC is designed for individuals with diabetes to monitor blood glucose levels conveniently. It combines a compact meter with an integrated lancing device and test strips, allowing users to perform self-monitoring at home. The system transmits results wirelessly to a paired smartphone, enabling real-time tracking of glucose levels and trends, which helps in better diabetes management.
How is the Dario LC system supplied, and what are its key components?
The Dario LC is supplied as a portable system that includes a meter, integrated lancing device, and test strips. It can be used as either a single-use or reusable system, depending on the specific components selected. The device also features two smartphone connectivity options: a model with a Lightning connector (1021-04) and one with a USB-C connector (1021-06).
Is the Dario LC system sterile, and how should it be stored?
The Dario LC system does not make specific sterility claims. Like most medical devices, it should be stored in a clean, dry environment, protected from extreme temperatures and direct sunlight. Follow manufacturer guidelines for proper handling and storage to maintain device functionality and hygiene.
Can the Dario LC be used in an MRI environment?
No, the Dario LC is not designed for use in MRI environments. Always ensure the device is removed and stored safely away from magnetic fields to avoid potential damage or interference.
What regulatory approval does the Dario LC hold, and how was it classified?
The Dario LC Blood Glucose Monitoring System holds FDA 510(k) clearance under the Clinical Chemistry advisory committee. It was classified as substantially equivalent (SESE) to a predicate device and received clearance on March 23, 2018, with the submission number K172723. This classification ensures it meets regulatory standards for safety and effectiveness.
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: PDF Dario® Blood Glucose Monitoring Systems User Guid, LABSTYLE DARIO LC USER MANUAL Pdf Download | ManualsLib, PDF Dario® Blood Glucose Monitoring Systems, LABSTYLE DARIO LC USER MANUAL Pdf Download | ManualsLib
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K172723 | Class II | Active |
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Manufacturer
- Manufacturer
- Labstyle Innovation Ltd
- FDA Applicant
- Labstyle Innovation, Ltd.
Sources (1)
- FDA 510(k) K172723 24 fields · synced Oct 5, 2026