NoCoding1 Plus Blood Glucose Monitoring System
FDA 510(k)Class II (US FDA 510(k))
by i-SENS, Inc.
Identifiers
- 510(k) Number
- K160742 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 NoCoding1 Plus Blood Glucose Monitoring System is an in vitro diagnostic device intended for the quantitative measurement of blood glucose. It is designed for use outside the body to monitor the effectiveness of diabetes management.
The system is intended for self-testing or healthcare professional use and should not be used for the diagnosis or screening of diabetes or for testing newborns. It requires a 0.5 μL blood sample and provides results in 5 seconds, meeting ISO 15197:2013 (EN ISO 15197:2015) standards.
Frequently asked questions
What is the NoCoding1 Plus Blood Glucose Monitoring System intended for?
The NoCoding1 Plus Blood Glucose Monitoring System is intended for the quantitative measurement of blood glucose in vitro, designed for use outside the body to monitor the effectiveness of diabetes management. It is suitable for self-testing or use by healthcare professionals but is not intended for the diagnosis or screening of diabetes or for testing newborns.
What sample size and test time does the NoCoding1 Plus system require?
The NoCoding1 Plus Blood Glucose Monitoring System requires a 0.5 μL blood sample and provides results in 5 seconds, as specified in its performance characteristics.
What regulatory pathway was used for the NoCoding1 Plus Blood Glucose Monitoring System?
The NoCoding1 Plus Blood Glucose Monitoring System received authorization through the FDA 510(k) pathway, as indicated by the FDA_510K authorization in the device data, with a traditional clearance type and a substantially equivalent decision.
What standards does the NoCoding1 Plus system meet for accuracy?
The NoCoding1 Plus Blood Glucose Monitoring System meets ISO 15197:2013 (EN ISO 15197:2015) standards for accuracy, which are referenced in the device description as the benchmark for its performance.
Who manufactures the NoCoding1 Plus Blood Glucose Monitoring System and where is it located?
The NoCoding1 Plus Blood Glucose Monitoring System is manufactured by i-SENS, Inc., located at 43, Banpo-Daer0 28-Gil, Seocho-Gu, Seoul, South Korea, with postal code 06646.
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: NoCoding1 Plus - i-SENS, Inc., i-SENS NoCoding1 Plus Owner's Booklet - ManualsLib, PDF i-sens NoCoding1 Plus Blood Glucose Monitoring System Owner's Manual, i-sens NoCoding1 Plus Blood Glucose Monitoring System Owner's Manual
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K160742 | Class II | Active |
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Manufacturer
- Manufacturer
- i-SENS, Inc.
Sources (1)
- FDA 510(k) K160742 24 fields · synced Sep 19, 2026