# K131750: Autosure HT Blood Glucose Monitoring System

- Pathway: 510(k) (Traditional)
- Applicant: Apex BioTechnology Corp.
- Decided: Mar 6, 2014 after 265 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: 5 generations back to K011233 (2001). 8 ancestors in all.
3 later devices descend from it; 1 cites it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K113208: Gal-1A Blood Glucose Monitoring System, Apex BioTechnology Corp. (2012) Summary page 1.
- K113098: Autosure Voice II Plus, Autosure Plus Blood Glucose Test Strips,Contrex Plus Iii, Apex BioTechnology Corp. (2012) Summary page 1.

## Most influential descendants
- K161299: BGM014 Blood Glucose Monitoring System, BGM014 Pro Blood Glucose Monitoring System (2016), 2 descendants of its own
- K222234: GlucoSure ADVANCE Link Blood Glucose Monitoring System (2022), 0 descendants of its own
- K182992: BGM014 Blood Glucose Monitoring System (2018), 0 descendants of its own

## Indications for use
The AutoSure HT Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips, forearm, or palm. Alternative site testing should be performed only during steady-state (when glucose is not changing rapidly). Testing is done outside the body (in Vitro diagnostic use). It is indicated for lay use by people with diabetes, as an aid to monitoring levels in Diabetes Mellitus and should only be used by a single patient and it should not be shared. It is not indicated for the diagnosis or screening of diabetes or for neonatal use. The AutoSure HT Blood Glucose Test Strips are to be used with the AutoSure HT Blood Glucose Meter to quantitatively measure glucose in capillary whole blood taken from fingertips, palm, or forearm. The Contrex Plus 4 glucose control solution is used with the AutoSure HT meter and AutoSure HT test strips to verify that the meter and test strips are working together properly and that the test is performing correctly.

Source page: https://510kreport.com/device/K131750
Methodology: https://510kreport.com/methodology