# K113636: Blood Glucose Monitoring System (Glucose Oxidase)

- Pathway: 510(k) (Traditional)
- Applicant: Philosys Co., Ltd.
- Decided: Mar 8, 2013 after 455 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 K002134 (2000). 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)
- K002134: One Touch Ultra Blood Glucose Monitoring System, Selfcare, Inc. (2000) Summary page 1.

## Indications for use
The Ornate® VOICE Blood Glucose Monitoring System is intended for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, hand, upper arm, forearm, calf or thigh as an aid in monitoring the effectiveness of diabetes management in the home by individuals with diabetes. The Ornate® VOICE Blood Glucose Monitoring System is intended to be used by a single user and should not be shared with any other person. The Gmate® VOICE Blood Glucose Monitoring System is for self-testing outside the body (in vitro diagnostic use only) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. The Ornate® VOICE Blood Glucose Monitoring System should not be used for the diagnosis or screening of diabetes or for neonatal use. Alternative site testing should be done only during steady-state times (when glucose is not changing rapidly). The Ornate® VOICE Blood Glucose Monitoring System includes a speaking feature that provides audible test results for diabetic users. The Ornate® Blood Glucose Test Strips are for use with the Ornate® VOICE Meter for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, hand, upper arm, forearm, calf or thigh. The Ornate® Control Solution is for use with the Ornate® VOICE Blood Glucose Monitoring System and is intended as a quality control measure to verify' the accuracy of your blood glucose test results and to ensure that the Ornate®&VOICE meter and Ornate® Test Strips are working properly. The Omate®) Control Solution is intended for use by people with diabetes at home.

Source page: https://510kreport.com/device/K113636
Methodology: https://510kreport.com/methodology