# K201037: FORA ADVANCED GD40 Glucose, ß-Ketone and Cholesterol Monitoring System

- Pathway: 510(k) (Traditional)
- Applicant: Taidoc Technology Corporation
- Decided: Jun 16, 2022 after 787 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: 8 generations back to K945887 (1995). 28 ancestors in all.
No later device cites it as a predicate yet.
1 of 29 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K161738: FORA ADVANCED GD40 and FORA ADVANCED GD40 pro Blood Glucose and ß-Ketone Monitoring Systems, Taidoc Technology Corporation (2016) Summary page 5.
- K163406: Mission Cholesterol Monitoring System, Mission Cholesterol Pro Monitoring System, ACON Laboratories, Inc. (2017) Summary page 5.

## Indications for use
The FORA ADVANCED GD40 Glucose, β-Ketone and Cholesterol Monitoring System consists of the FORA ADVANCED GD40 meter, the FORA ADVANCED GD40 Blood Glucose strips, the FORA ADVANCED GD40 β-Ketone strips, and the FORA ADVANCED GD40 Total Cholesterol strips. The FORA ADVANCED GD40 Glucose, β-Ketone and Cholesterol Monitoring System is intended for the quantitative measurement of glucose, beta-hydroxybutyrate (β-ketone), and cholesterol in fresh capillary whole blood from the finger. This system is intended for single-patient home use and should not be shared. This device is intended for use by patients with diabetes. It is only for use outside the body (in vitro diagnostic use). Glucose and β-ketone measurements are used as an aid to monitor the effectiveness of a diabetes control program. Glucose measurements should not be used for the diagnosis of or screening for diabetes. Cholesterol measurements are used in the diagnosis and treatment of disorders involving excess cholesterol in the blood and lipid and lipoprotein metabolism disorders. Cholesterol should be measured at the frequency recommended by your healthcare provider.

Source page: https://510kreport.com/device/K201037
Methodology: https://510kreport.com/methodology