# K161738: FORA ADVANCED GD40 and FORA ADVANCED GD40 pro Blood Glucose and ß-Ketone Monitoring Systems

- Pathway: 510(k) (Traditional)
- Applicant: Taidoc Technology Corporation
- Decided: Nov 10, 2016 after 140 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: 7 generations back to K945887 (1995). 14 ancestors in all.
2 later devices descend from it; 2 cite it directly.
1 of 17 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K091547: Nova Max Plus Blood Glucose and B-Ketone Monitor System, Nova Max Plus B-Ketone Control Solutions, Nova Max Blood Glucos, Nova Biomedical Corp. (2010) Summary page 8.

## Most influential descendants
- K201037: FORA ADVANCED GD40 Glucose, ß-Ketone and Cholesterol Monitoring System (2022), 0 descendants of its own
- K173345: TD-4140 Smart Dongle Blood Glucose plus B-ketone Monitoring System (2018), 0 descendants of its own

## Indications for use
FORA ADVANCED GD40 Blood Glucose and ȕ-Ketone Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood from the finger, and for the quantitative measurement of ȕ-ketone (beta-hydroxybutyrate) in fresh capillary whole blood from the finger. The FORA ADVANCED GD40 is intended for in vitro diagnostic use and is intended for single-patient use as an aid to monitor the effectiveness of a diabetes control program. The system should not be used for the diagnosis of or screening for diabetes, nor for use on neonates. FORA ADVANCED GD40 Blood Glucose Test Strips are for use with the FORA ADVANCED GD40 Blood Glucose and ȕ-Ketone Meter to quantitatively measure glucose in fresh capillary whole blood samples drawn from the finger. The FORA ADVANCED GD40 Blood ȕ-Ketone Test Strips are for use with the FORA ADVANCED GD40 Blood Glucose and ȕ-Ketone Meter to quantitatively measure ȕ-ketone in fresh capillary whole blood samples drawn from the finger. ȕ-Ketone Control Solutions are intended for use with FORA ADVANCED GD40 Blood Glucose and ȕ-Ketone Monitoring System to check that the meters and test strips are working together properly and that the test is performing correctly. FORA ADVANCED GD40 pro Blood Glucose and ȕ-Ketone Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood from the finger, and from venous, and neonatal capillary heelstick whole blood, and for the quantitative measurement of ȕ-ketone (beta-hydroxybutyrate) in fresh capillary whole blood from the finger, and from venous whole blood. The FORA ADVANCED GD40 pro is intended for in vitro diagnostic use and is intended for multiple-patient use in professional healthcare settings as an aid to monitor the effectiveness of a diabetes control program. This system should only be used with single-use, auto-disabling lancing devices. The system should not be used for the diagnosis of or screening for diabetes. FORA ADVANCED GD40 pro Blood Glucose Test Strips are for use with the FORA ADVANCED GD40 pro Blood Glucose and ȕ-Ketone Meter to quantitatively measure glucose in fresh capillary whole blood samples drawn from the fingertips, and from venous and neonatal whole blood. The FORA ADVANCED GD40 pro Blood ȕ-Ketone Test Strips are for use with the FORA ADVANCED GD40 pro Blood Glucose and ȕ-Ketone Meter to quantitatively measure ȕ-ketone in fresh capillary whole blood samples drawn from the fingertips and from venous whole blood. ȕ-Ketone Control Solutions are intended for use with FORA ADVANCED GD40 Blood Glucose and ȕ-Ketone Monitoring System to check that the meters and test strips are working together properly and that the test is performing correctly.

Source page: https://510kreport.com/device/K161738
Methodology: https://510kreport.com/methodology