# K132338: DA01 Blood Glucose Monitoring System

- Pathway: 510(k) (Special)
- Applicant: Delbio Incorporation
- Decided: Oct 24, 2013 after 90 days
- Product code: NBW (System, Test, Blood Glucose, Over The Counter)
- Device class: 2
- Regulation: 21 CFR 862.1345
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
DA01 Blood Glucose Monitoring System is intended for use outside the body (in vitro diagnostic use) at home. It is used for quantitative measurement of glucose level in fresh capillary whole blood sample (from the finger and the palm,). The alternate site testing can be only used during steady-state blood glucose monitoring. The DA0i Blood Glucose Monitoring System is intended for use by a single person and should not be shared. In addition, it is intended for use at home as an aid in monitoring the effectiveness of diabetes control program. It should not be used for the diagnosis or screening of diabetes, nor for the testing of neonates. The DA01 Blood Glucose Test Strips are used with the DAO1 Glucose meter to quantitatively measure glucose in fresh capillary whole blood samples drawn from the finger and the palm. The DiaL-ife mini is a PC-based software intended for use in the home setting by people with diabetes. It is intended to aid in the review, analysis, and evaluation of patient data to support diabetes management. The DiaL-ife mini software receives via USB, stores, and uses patient data for display and reporting. It is intended for use as an accessory to DELBio DA01 Blood Glucose Monitoring System.

Source page: https://510kreport.com/device/K132338
Methodology: https://510kreport.com/methodology