# K070088: Assure 4 Blood Glucose Monitoring System

- Pathway: 510(k) (Special)
- Applicant: Apex BioTechnology Corp.
- Decided: Feb 16, 2007 after 38 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. The FDA summary names its predicate without a number.
- (no number) Glucosure BGM: named in the summary without a submission number
- (no number) Assure 3: named in the summary without a submission number

## Indications for use
The Assure 4 Blood Glucose Meter is intended for the quantitative measurement of glucose in fresh capillary whole blood drawn from the fingertip. Testing is done outside the body (In Vitro diagnostic use). It is indicated for use at home (over the counter [OTC]) by persons with diabetes or in clinical settings by healthcare professionals, as an aid to monitor the effectiveness of diabetes control.

Source page: https://510kreport.com/device/K070088
Methodology: https://510kreport.com/methodology