# K090629: Easy Step and Diachex+ Pro Blood Glucose Monitoring Systems

- Pathway: 510(k) (Special)
- Applicant: Tyson Bioresearch, Inc.
- Decided: Jun 4, 2009 after 87 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: 5 generations back to K964630 (1997). 6 ancestors in all.
2 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)
- K073492: Diachex+Determine Blood Glucose Monitoring System, Diachex-Infinity Blood Glucose Monitoring System, Tyson Bioresearch, Inc. (2008) Summary page 2.

## Most influential descendants
- 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 Easy Step / DIACHEX+ PRO Blood Glucose Monitoring System is intended for use in the quantitatively measurement of glucose (sugar) in fresh capillary whole blood from the fingertip and the alternative sites: the palm and the forearm. The Easy Step / DIACHEX + PRO Blood Glucose Test Strips are for testing outside the body (in vitro, diagnostic use). The Easy Step / DIACHEX + PRO Blood Glucose Monitoring System is intended for use at home (over the counter [OTC]) by persons with diabetes, or in clinical setting by healthcare professionals as an aid in monitoring the effectiveness of diabetes control. It is not intended for the diagnosis of or screening for diabetes mellitus. The alternative site testing in the systems can be used only during steady-state blood glucose conditions. It is not intended for neonatal testing.

Source page: https://510kreport.com/device/K090629
Methodology: https://510kreport.com/methodology