# K062829: Diachex Blood Glucose Monitoring System

- Pathway: 510(k) (Special)
- Applicant: Tyson Bioresearch, Inc.
- Decided: Oct 10, 2006 after 20 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: 3 generations back to K964630 (1997). 4 ancestors in all.
4 later devices descend from it; 1 cites it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K052818: EZ Smart-168 Glucose Monitoring System, Tyson Bioresearch, Inc. (2006) Summary page 2.

## Most influential descendants
- K073492: Diachex+Determine Blood Glucose Monitoring System, Diachex-Infinity Blood Glucose Monitoring System (2008), 3 descendants of its own
- K090629: Easy Step and Diachex+ Pro Blood Glucose Monitoring Systems (2009), 2 descendants of its own
- K101543: Tysonbio Blood Glucose Monitoring System, Models AC100 and AC200 (2011), 1 descendant of its own
- K123087: Tysonbio AC500, AC800 Blood Glucose Monitoring System, Tysonbio AC500 AC800 Pro Blood Glucose Monitoring System (2013), 0 descendants of its own

## Indications for use
The DIACHEX Blood Glucose Test Strips are used with the DIACHEX Blood Glucose Meter for quantitatively measuring glucose (sugar) in fresh capillary whole blood obtained from the fingertip. The DIACHEX Strips are for testing outside the body (in vitro diagnostic use). The DIACHEX Blood Glucose Monitoring System is intended for use in the home and in professional settings to monitor blood glucose levels for better glucose control among diabetics.

Source page: https://510kreport.com/device/K062829
Methodology: https://510kreport.com/methodology