# K091102: Assure Platinum and Glucocard Vital Blood Glucose Monitoring Systems

- Pathway: 510(k) (Traditional)
- Applicant: Arkray Factory USA, Inc.
- Decided: Oct 23, 2009 after 190 days
- Product code: CGA (Glucose Oxidase, Glucose)
- 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 K063068 (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)
- K063068: Ferrara Blood Glucose Monitoring System, Model 631100, Arkray USA, Inc. (2006) Summary page 1.

## Indications for use
The GLUCOCARD® VitalTM Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips and palms. 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. The GLUCOCARD® VitalTM Blood Glucose Monitoring System is not intended for the diagnosis of or screening for diabetes mellitus, and is not intended for use on neonates. The GLUCOCARD® VitalTM Blood Glucose Meter is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips and palms. 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. GLUCOCARD® VitaI TM test strips are intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips and palms when used with the GLUCOCARD® VitalTM 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. For use with GLUCOCARD® VitalTM Blood Glucose Meter and GLUCOCARD® VitalTM 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/K091102
Methodology: https://510kreport.com/methodology