DA01 Blood Glucose Monitoring System
by Delbio Incorporation 2 variants
510(k) K132338
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK132338 | Date24 Oct 2013 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- NBW
- Device Class
- Class II
- Regulation
- 21 CFR Part 862.1345
- Advisory Committee
- Clinical Chemistry
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The DA01 Blood Glucose Monitoring System is a test system classified as a blood glucose monitor, designed to measure glucose levels quantitatively in blood and other body fluids. It is intended for use in the management and monitoring of carbohydrate metabolism disorders, including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia. The device provides quantitative glucose readings to aid in clinical decision-making and patient care.
This system is supplied as a single-use or reusable device, depending on the components used, and is regulated under FDA 510(k) clearance (K132338) as a Class II device under Special Controls. It is intended for over-the-counter use and is not specified as MRI-safe or sterile. Storage and handling instructions are not detailed in the provided data, but compliance with manufacturer guidelines is essential for accurate results.
Other devices from Delbio Incorporation
Questions
AI-generated answers, 1 Oct 2026
What is the DA01 Blood Glucose Monitoring System used for?
The DA01 Blood Glucose Monitoring System is designed to measure glucose levels quantitatively in blood and other body fluids. It aids in the management and monitoring of carbohydrate metabolism disorders, including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia. By providing accurate glucose readings, it supports clinical decision-making and patient care for these conditions.
Is the DA01 Blood Glucose Monitoring System single-use or reusable?
The DA01 Blood Glucose Monitoring System can be used as either a single-use or reusable device, depending on the specific components included in the system. This flexibility allows for different usage scenarios based on clinical needs and operational preferences.
Is the DA01 Blood Glucose Monitoring System sterile?
The provided data does not specify that the DA01 Blood Glucose Monitoring System is sterile. If sterility is required for a particular use case, it is important to verify this with the manufacturer’s guidelines or additional documentation, as sterility may vary depending on the components used.
What regulatory approval does the DA01 Blood Glucose Monitoring System hold?
The DA01 Blood Glucose Monitoring System is regulated under FDA 510(k) clearance with the clearance number K132338. It is classified as a Class II device under Special Controls and is intended for over-the-counter use. This clearance indicates that the device has been deemed substantially equivalent to a legally marketed predicate device.
How should the DA01 Blood Glucose Monitoring System be stored?
The provided data does not detail specific storage instructions for the DA01 Blood Glucose Monitoring System. However, to ensure accurate and reliable results, it is essential to follow the manufacturer’s guidelines for storage and handling. Proper storage conditions are critical for maintaining the device’s performance and longevity.