# K123007: Veri-Q MGD-1001 Blood Glucose Monitoring System, Veri-Q Plus MGD-1001 Blood Glucose Monitoring System

- Pathway: 510(k) (Traditional)
- Applicant: Mico Biomed Co., Ltd.
- Decided: Jun 19, 2013 after 265 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: 3 generations back to K024194 (2003). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K083468: Caresens N Blood Glucose Monitoring System, Caresens N Meter, Model GM5051A or GM5051B or GM5051C (Color), I-Sens, Inc. (2009) Summary page 1.

## Indications for use
The Veri-Q self-testing MGD-1001 Blood Glucose Monitoring System is intended for use in the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from fingertips, palm, or forearm. The Veri-Q self-testing MGD-1001 Blood Glucose Monitoring System is intended to be used by a single patient and should not be shared. The Veri-Q self-testing MGD-1001 Blood Glucose Monitoring System is intended for self-testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. The Veri-Q self-testing MGD-1001 Blood Glucose Monitoring System should not be used for the diagnosis of or screening for diabetes or for neonatal use. Alternative site testing should be done only during steady-state times (when glucose is not changing rapidly). The Veri-Q self-testing MGS-01 test strips are for use with the Veri-Q self-testing MGD-1001 meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from fingertips, palm, or forearm. The Veri-Q self-testing Glucose Control Solutions are for use with the Veri-Q self-testing MGD-1001 meter and the Veri-Q self-testing MGS-01 test strips to check that the meter and test strips are working together properly and providing accurate results. The Veri-Q plus MGD-1001 Blood Glucose Monitoring System is intended for use in the quantitative measurement of glucose (sugar) in fresh capillary whole blood drawn from fingertips, palm, or forearm. The Veri-Q plus MGD-1001 Blood Glucose Monitoring System is intended for testing outside the body (in vitro diagnostic use). The Veri-Q plus MGD-1001 Blood Glucose Monitoring System is intended for multi-patient use in a professional healthcare setting, as an aid to monitor the effectiveness of diabetes control. This system is only used with single-use, auto-disabling lancing devices. The Veri-Q plus MGD-1001 Blood Glucose Monitoring System should not be used for the diagnosis of or screening for diabetes or for neonatal use. Alternative site testing should be done only during steady-state times (when glucose is not changing rapidly). The Veri-Q plus MGS-01 test strips are for use with the Veri-Q plus MGD-1001 meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from fingertips, palm, or forearm. The Veri-Q plus Glucose Control Solutions are for use with the Veri-Q plus MGD-1001 meter and the Veri-Q plus MGS-01 test strips to check that the meter and test strips are working together properly and providing accurate results.

Source page: https://510kreport.com/device/K123007
Methodology: https://510kreport.com/methodology