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Auto-Chek Blood Glucose Monitoring System, Meter, Test Strip, Auto-Check Control Solution

FDA 510(k)

Class II (US FDA 510(k))

510(k) K121654

by i-SENS, Inc.

Identifiers

510(k) Number
K121654 FDA 510(k)
FDA Product Code
CGA 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 Auto-Chek Blood Glucose Monitoring System is a device intended for single patient home use to measure blood glucose levels. It includes a meter, test strips, and control solution for monitoring blood sugar levels.

The device is supplied by i-SENS, Inc. and is classified as a Class II medical device with FDA 510(k) clearance. It is not specified as MRI safe, and no information is provided regarding sterility, single-use or reusable status, or storage conditions.

Frequently asked questions

What is the Auto-Chek Blood Glucose Monitoring System used for?

The Auto-Chek Blood Glucose Monitoring System is intended for single patient home use to measure blood glucose levels. It includes a meter, test strips, and control solution for monitoring blood sugar levels.

Is the Auto-Chek Blood Glucose Monitoring System reusable or single-use?

The device is not specified as reusable or single-use in the provided information. The system includes a meter, test strips, and control solution, but the reusability status is not explicitly stated.

What are the storage conditions for the Auto-Chek Blood Glucose Monitoring System?

No information is provided regarding storage conditions for the Auto-Chek Blood Glucose Monitoring System in the device data.

Does the Auto-Chek Blood Glucose Monitoring System have FDA clearance?

Yes, the Auto-Chek Blood Glucose Monitoring System has FDA 510(k) clearance, which means it has been determined to be substantially equivalent to other legally marketed devices.

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: Auto-chek Blood Glucose Monitoring System, Meter, Test Strip. Auto ..., Auto-chek Blood Glucose Monitoring System, Meter, Test Strip. Auto ..., Blood Glucose Monitoring - Accu-Chek, Blood Glucose Monitoring - Accu-Chek, Amazon.com: Accu- Chek

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
i-SENS, Inc.

Sources (1)

  • FDA 510(k) K121654 24 fields · synced Oct 6, 2026