# K090653: Pocketchem EZ Blood Glucose Monitoring System

- Pathway: 510(k) (Traditional)
- Applicant: Arkray Factory USA, Inc.
- Decided: Oct 9, 2009 after 212 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 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
PocketChem EZ Blood Glucose Monitoring System: The PocketChem EZ 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 PocketChem EZ Blood Glucose Monitoring System is not intended for the diagnosis of or screening for diabetes mellitus, and is not intended for use on neonates. PocketChem EZ Blood Glucose Meter: The PocketChem EZ 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. The PocketChem EZ Blood Glucose Meter is not intended for the diagnosis of or screening for diabetes mellitus, and is not intended for use on neonates. PocketChem EZ Blood Glucose Test Strips: PocketChem EZ 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 PocketChem EZ 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. The PocketChem EZ Blood Glucose Test Strips are not intended for the diagnosis of or screening for diabetes mellitus, and are not intended for use on neonates. Assure Dose CONTROL: For use with PocketChem EZ Blood Glucose Meter and PocketChem EZ 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/K090653
Methodology: https://510kreport.com/methodology