# K100747: Contrex Plus Low Control Solution

- Pathway: 510(k) (Traditional)
- Applicant: Apex BioTechnology Corp.
- Decided: Apr 14, 2010 after 29 days
- Product code: JJX (Single (Specified) Analyte Controls (Assayed And Unassayed))
- Device class: 1
- Regulation: 21 CFR 862.1660
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
13 later devices descend from it; 1 cites it directly.
0 of 14 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) Contrex Plus Level I and Level 2 Control Solutions: named in the summary without a submission number

## Most influential descendants
- K102816: Gal-1C Blood Glucose Monitoring System, Gal-1C Test Strips (2011), 12 descendants of its own
- K113208: Gal-1A Blood Glucose Monitoring System (2012), 9 descendants of its own
- K141036: BGM009 Blood Glucose Monitoring System (2015), 3 descendants of its own
- K131750: Autosure HT Blood Glucose Monitoring System (2014), 3 descendants of its own
- K170267: BGM009 Plus Blood Glucose Monitoring System (2017), 2 descendants of its own

## Indications for use
The purpose of the control solution test is to validate the performance of the GlucoSure STAR & GlucoTRACK Blood Glucose Monitoring Systems using a testing solution with a known range of glucose. A control test that falls within the acceptable range indicates the user's technique is appropriate and the test strip and meter are functioning properly.

Source page: https://510kreport.com/device/K100747
Methodology: https://510kreport.com/methodology