# K111890: Fora Diamond Prima Blood Glucose Monitoring System, Fora Diamond Mini Blood Glucose Monitoring System

- Pathway: 510(k) (Traditional)
- Applicant: Taidoc Technology Corporation
- Decided: Feb 6, 2012 after 220 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: 4 generations back to K031755 (2003). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K100322: TD-4277 Blood Glucose Monitoring System, Model 4277, Taidoc Technology Corporation (2010) Summary page 3.

## Indications for use
FORA Diamond Prima Blood Glucose Monitoring System is intended for self testing outside the body (in vitro diagnostic use) in the quantitative measurement of glucose in fresh capillary whole blood from the finger. The system is intended for use by people with diabetes mellitus at home as an aid in monitoring the effectiveness of diabetes control program. It is not intended for the diagnosis of or screening for diabetes mellitus, and is not intended for use on neonates. This system is intended for single-patient use (lay-users at home) and should not be shared. The FORA Diamond Prima Blood Glucose Test Strips are for use with the FORA Diamond Prima Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips. FORA Diamond Mini Blood Glucose Monitoring System is intended for self testing outside the body (in vitro diagnostic use) in the quantitative measurement of glucose in fresh capillary whole blood from the finger. The system is intended for use by people with diabetes mellitus at home as an aid in monitoring the effectiveness of diabetes control program. It is not intended for the diagnosis of or screening for diabetes mellitus, and is not intended for use on neonates. This system is intended for single-patient use and should not be shared. The FORA Diamond Mini Blood Glucose Test Strips are for use with the FORA Diamond Mini Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips.

Source page: https://510kreport.com/device/K111890
Methodology: https://510kreport.com/methodology