# K102383: Microdot & Microdot Xtra

- Pathway: 510(k) (Traditional)
- Applicant: Cambridge Sensors Limited
- Decided: Jan 27, 2012 after 522 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: 2 generations back to K070524 (2007). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K070524: Microdot Blood Glucose Monitoring System, Cambridge Sensors Limited (2007) Summary page 3.
- K083273: Microdot Xtra, Cambridge Sensors Limited (2009) Summary page 3.

## Indications for use
The mnicrodot®0Home Blood Glucose Monitoring System is intended for self testing outside the body (in vitro diagnostic use only), by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. It is intended for "single patient-home use" only and should not be shared. It should be used only for testing fresh capillary whole blood samples from a fingerstick or palm for glucose (sugar). Alternate site testing should be done only during steady-state times (when glucose is not changing rapidly). It is not intended for use on neonates or in the diagnosis of or screening for diabetes mellitus. The system consists of the microdot ®Home Blood Glucose meter, microdot® Home Test Strips and microdot ® Control solutions. microdot 0Home Test Strips The microdot ® Home Test strips are intended for the quantitative measurement of glucose in fresh capillary whole blood from a fingerstick or palm.

Source page: https://510kreport.com/device/K102383
Methodology: https://510kreport.com/methodology