CareSens N POP Blood Glucose Monitoring System
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
by i-SENS, Inc.
Identifiers
- 510(k) Number
- K120351 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 CareSens N POP Blood Glucose Monitoring System is a blood glucose meter (Device Type: NBW) designed for self-monitoring of blood glucose levels. It integrates a meter and test strips to provide accurate readings for diabetes management, featuring auto-coding functionality to streamline measurement processes.
This system is supplied as a reusable meter paired with single-use test strips (CareSens N Blood Glucose Test Strip CA). It requires no special storage conditions and is intended for home use. The device holds up to 1,000 measurement records and operates on replaceable batteries. Authorized under FDA 510K clearance (K120351) and IVDD compliance, it adheres to clinical chemistry standards for glucose monitoring.
Frequently asked questions
Is the CareSens N POP Blood Glucose Monitoring System designed for professional use in a clinical setting, or is it intended for home use by patients?
The CareSens N POP Blood Glucose Monitoring System is explicitly designed for home use by patients. The description highlights its integration of a reusable meter and single-use test strips, which aligns with self-monitoring needs rather than clinical or professional settings.
How many blood glucose readings can the meter store before requiring data transfer or clearing?
The meter can store up to 1,000 measurement records, which is useful for tracking trends over time without needing frequent data downloads or resets.
Are the test strips for this system single-use only, or can they be reused for multiple measurements?
The test strips (CareSens N Blood Glucose Test Strip CA) are single-use only, as indicated by the system’s description of pairing a reusable meter with disposable strips. Reusing strips could compromise accuracy and sterility.
Does the CareSens N POP meter require any special storage conditions, or can it be kept at room temperature?
The meter does not require special storage conditions—it can be stored at room temperature, making it convenient for home use without additional environmental controls.
What type of battery does the CareSens N POP meter use, and how is it replaced?
The meter operates on replaceable batteries, though the specific type isn’t detailed. Most blood glucose meters use standard batteries like AA or lithium, and replacement would follow the manufacturer’s instructions for the device.
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: CareSens N - i-SENS, Inc., i-SENS CareSens N POP Owner's Booklet - ManualsLib, I-SENS CARESENS N POP MANUAL Pdf Download | ManualsLib, CareSens N Blood Glucose Monitor Kit with 100 Blood Sugar Test ... - Amazon
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 | K120351 | Class II | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- i-SENS, Inc.
Sources (2)
- FDA 510(k) K120351 24 fields · synced Oct 6, 2026
- EUDAMED 1 fields · synced May 18, 2026