# K083273: Microdot Xtra

- Pathway: 510(k) (Traditional)
- Applicant: Cambridge Sensors Limited
- Decided: Nov 19, 2009 after 378 days
- Product code: NBW (System, Test, Blood Glucose, Over The Counter)
- Device class: 2
- Regulation: 21 CFR 862.1345
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K070524 (2007). 1 ancestor in all.
1 later device descends from it; 1 cites 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)
- K070524: Microdot Blood Glucose Monitoring System, Cambridge Sensors Limited (2007) Summary page 3.

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

## Recalls of this device
- Jul 26, 2018 · Class II · Z-2357-2019: The firm reported that a faulty cutting/punching machine did not meet specifications after being fitted with new blades and did not correctly "notch" BG test strips intended for use in the US. The imp

## Indications for use
The microdot Xtra ®Blood Glucose Monitoring System is intended for self test use outside the body (in vitro diagnostic use only). It should be used only for testing fresh capillary whole blood samples from a fingerstick for glucose (sugar). It is not intended for use on neonates or in the diagnosis of or screening for diabetes mellitus. The microdotXtra ® Blood Glucose Monitoring System is intended for self testing of glucose in capillary whole blood from a fingerstick by persons with diabetes or by health care professionals in home settings or healthcare facilities. The microdot Xtra ® 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. The microdot Xtra ® 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. The microdot®Control solutions are intended for use with microdot Xtra ® Blood Glucose Meter and microdot Xtra ® Test Strips as a quality control check to verify the accuracy of the blood glucose test results.

Source page: https://510kreport.com/device/K083273
Methodology: https://510kreport.com/methodology