Major III Blood Glucose Monitoring System

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K072274 ↗

FDA Product Code

NBW

Device Class

Class II

Regulation

21 CFR Part 862.1345

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

• Ap-1010 and Ap-1020 Blood Glucose Monitoring System, Major Glucose Control Solution

  Class II

  FDA 510(k) K103044 Active Cleared 10 Feb 2012

• Ap-2000, Ap-2010, and Ap-2020 Blood Glucose Monitoring System

  Class II

  FDA 510(k) K103116 Active Cleared 13 Mar 2012

• Ap-1000 Blood Glucose Monitoring System, Model Ap-1000, Major Glucose Control Solution

  Class II

  FDA 510(k) K100437 Active Cleared 12 Jan 2012

• Ap-1000 Blood Glucose Monitoring System

  Class II

  FDA 510(k) K090389 Active Cleared 14 Jul 2009

• Ap-3000 Blood Glucose Monitoring System, Major Glucose Control Solution

  Class II

  FDA 510(k) K103230 Active Cleared 24 Apr 2012

• What types of settings can the Major III Blood Glucose Monitoring System be used in, and who is it intended for?

  The Major III Blood Glucose Monitoring System is designed for use in both home and clinical settings. It is intended for individuals with diabetes to monitor their glucose levels in real-time, as well as healthcare professionals who may need to check blood glucose levels for patients.

• Is the Major III Blood Glucose Monitoring System single-use or reusable, and what does that mean for its use?

  The Major III Blood Glucose Monitoring System is supplied as a single-use device. This means each test strip and meter combination is intended for one-time use only, ensuring accuracy and hygiene for each measurement. After use, the components should be discarded to avoid contamination or measurement errors.

• What type of blood sample does the Major III Blood Glucose Monitoring System require, and how is it collected?

  The device requires a fresh capillary whole blood sample, typically collected from a small prick on the fingertip. This type of sample is standard for home glucose monitoring and is easy to obtain for self-testing or clinical use.

• How is the regulatory status of the Major III Blood Glucose Monitoring System determined, and what does that mean for buyers?

  The Major III Blood Glucose Monitoring System holds an FDA 510(k) clearance under product code NBW, classified as substantially equivalent to a predicate device. This means it has been reviewed and deemed safe and effective for its intended use as a blood glucose test system, allowing it to be legally marketed and sold in the U.S. without additional approvals for this specific indication.

• Are there any special handling or storage requirements for the Major III Blood Glucose Monitoring System?

  The provided data does not specify special handling or storage requirements for the Major III Blood Glucose Monitoring System. However, as with most blood glucose monitoring systems, it is generally recommended to store test strips in a cool, dry place away from direct sunlight and extreme temperatures to maintain their accuracy and shelf life. Always follow the manufacturer’s instructions for optimal performance.