# K070524: Microdot Blood Glucose Monitoring System

- Pathway: 510(k) (Traditional)
- Applicant: Cambridge Sensors Limited
- Decided: Jun 22, 2007 after 119 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
No predicates in its family tree.
2 later devices descend from it; 2 cite it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) LifeScan One Touch Ultra blood glucose testing system: named in the summary without a submission number

## Most influential descendants
- K083273: Microdot Xtra (2009), 1 descendant of its own
- K102383: Microdot & Microdot Xtra (2012), 0 descendants of its own

## Indications for use
microdot Blood Glucose Monitoring System The microdot Blood Glucose Monitoring System is intended for self testing of glucose in capillary whole blood by persons with diabetes or by health care professionals in home settings or healthcare facilities. It is intended for monitoring of blood glucose levels only. microdot Blood Glucose Meter The microdot Blood Glucose Meter is intended for the quantitative measurement of glucose in fresh capillary whole blood from a fingerstick. It is intended for use by persons with diabetes or by health care professionals in home settings or healthcare facilities. It is intended for monitoring of blood glucose levels only. microdot Test Strips The microdot Test Strips are intended for the quantitative measurement of glucose in fresh capillary whole blood from a fingerstick. It is intended for use by persons with diabetes or by health care professionals in home settings or healthcare facilities. It is intended for monitoring of blood glucose levels only. microdot Control solutions The microdot Control solutions are intended for use with microdot Blood Glucose Meter and microdot Test Strips as a quality control check to verify the accuracy of the blood glucose test results.

Source page: https://510kreport.com/device/K070524
Methodology: https://510kreport.com/methodology