Fora MD Control, POCT S10 (TD-4258)

Device Name:

Fora MD Control, POCT S10

Device Model:

TD-4258

Manufacturer:

Distributer: ForaCare Inc., Suite D, 893 Patriot Drive, Moorpark, CA 93021, UNITED STATES.

OBL: ForaCare Suisse AG, Neugasse 55, CH-9000 St. Gallen, SWITZERLAND.

OEM: TaiDoc Technology Corporation, 6F - 127 Wugong 2nd Road, 24888 Wugu District, New Taipei City, TAIWAN ROC.

Measuring functions:

Blood glucose

Primary Client Use:

Intended for professional use

Measurement Site:

Finger

Measurement Occurrence:

Single measurements only

Availability:

Discontinued but still available

Availability according to Countries or Regions:

United States

Description:

The Fora MD Control, POCT S10 (TD-4258) is an automatic blood glucose meter. The accuracy of its blood glucose measurement technology has yet to be proven to MDR requirements. Blood glucose measurements are taken from the finger. It is intended for professional use. This device has been discontinued by the manufacturer but may be available through certain outlets.

Assessment:

While the technology used in the Fora MD Control, POCT S10 (TD-4258), to measure blood glucose, has been assessed, the results of the study have not been published and cannot be verified. It also appears to be very similar to another device by the same (OEM) manufacturer, but equivalence needs to be proven according to a protocol compliant with (EU) 2017/745 and MEDDEV 2.7/1 rev 4.

Recommendations:

	Accuracy Assessment	Recommendation	Basis
BG	Medaval	None	Although equivalence to another device is claimed, this has not been tested to MDR requirements.
BG	TÜV Rheinland Nederland	General use	Unpublished internal data

Device Family:

Fora MD Control, POCT S10 (TD-4258)Z, TaiDoc TD-4258 VTrust POCTZ, TaiDoc TD-4258C VTrust POCTZ
Legend: Z Almost Certain