# K090332: Assure Pro Blood Glucose Monitoring System, Model 46001

- Pathway: 510(k) (Traditional)
- Applicant: Arkray Factory USA, Inc.
- Decided: Aug 14, 2009 after 185 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
Longest line of descent: 1 generation back to K053079 (2006). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K053079: Assure Pro Blood Glucose Monitoring System, Model 460001, Hypoguard USA, Inc. (2006) Summary page 1.

## Indications for use
Assure Pro Blood Glucose Monitoring System: The Assure Pro Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips. 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 clinicar settings by healthcare professionals, as an aid to monitor the effectiveness of diabetes control. The Assure Pro Blood Glucose Monitoring System is not intended for the diagnosis of or screening for diabetes mellitus, and is not intended for use on neonates. Assure Pro Blood Glucose Meter: The Assure Pro Blood Glucose Meter is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips. 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. Assure Pro Blood Glucose Test Strips: Assure Pro test strips are intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips when used with the Assure Pro Blood Glucose Meter. Testing is done outside the body (In Vitro diagnostic use). They are indicated for use in 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. Assure Dose CONTROL: For use with Assure Pro Blood Glucose Meter and Assure Pro Blood Glucose Test Strips as a quality control check to verify the accuracy of blood glucose test results. Control solutions are available in two levels - Level 1 (Normal) and Level 2(High).

Source page: https://510kreport.com/device/K090332
Methodology: https://510kreport.com/methodology