# K970707: Elect II Blood Glucose Monitoring System

- Pathway: 510(k) (Traditional)
- Applicant: Selfcare, Inc.
- Decided: Jun 20, 1997 after 114 days
- Product code: CGA (Glucose Oxidase, Glucose)
- 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: 1 generation back to K945887 (1995). 2 ancestors in all.
36 later devices descend from it; 2 cite it directly.
3 of 39 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K961985: Elect Blood Glucose Monitorig System, Selfcare, Inc. (1996) Summary page 1.
- K945887: Precision Q I D Blood Glucose Test Strips, Medisense, Inc. (1995) Summary page 1.

## Most influential descendants
- K992684: Freestyle Blood Glucose Monitoring System (2000), 33 descendants of its own
- K012014: Modification to Blood Glucose Monitoring System (2001), 23 descendants of its own
- K020866: Freestyle Tracker Diabetes Management System (2002), 22 descendants of its own
- K031260: Freestyle Blood Glucose Monitoring System, Freestyle Tracker Diabetes Management System, Models 11001, 16000, and 16005 (2003), 18 descendants of its own
- K050500: Freestyle 600 Blood Glucose Monitoring System (2005), 12 descendants of its own

## Indications for use
The Elect II Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose in fresh capillary whole blood. The Elect II System is intended for use outside the body (in vitro diagnostic use) by diabetics at home as an aid to monitor the effectiveness of diabetes control.

Source page: https://510kreport.com/device/K970707
Methodology: https://510kreport.com/methodology