# K961985: Elect Blood Glucose Monitorig System

- Pathway: 510(k) (Traditional)
- Applicant: Selfcare, Inc.
- Decided: Sep 5, 1996 after 107 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
No predicates in its family tree.
37 later devices descend from it; 1 cites it directly.
3 of 38 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) Precision QID Blood Glucose Monitoring System: named in the summary without a submission number
- (no number) Glucometer Elite Diabetes Care System: named in the summary without a submission number

## Most influential descendants
- K970707: Elect II Blood Glucose Monitoring System (1997), 36 descendants of its own
- 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

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

Source page: https://510kreport.com/device/K961985
Methodology: https://510kreport.com/methodology