# K000318: Bionostics Glucose Quality Control Solution for Use with the Fasttake Compact Blood Glucose Monitoring System

- Pathway: 510(k) (Traditional)
- Applicant: Bionostics, Inc.
- Decided: Feb 28, 2000 after 27 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.
11 later devices descend from it; 2 cite 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)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K022769: Lifescan Onetouch Ultra Control Solution (2002), 9 descendants of its own
- K160179: VivaChek Ino Blood Glucose Monitoring System (2017), 4 descendants of its own
- K173140: VivaChek Ino Smart Blood Glucose Monitoring System, VivaChek Ino Sync Blood Glucose Monitoring System, VivaChek Ino Sound Blood Glucose Monitoring System, VivaChek Ino Plus Blood Glucose Monitoring System, VivaChek Ino Sound Simple Blood Glucose Monitoring System, VivaChek Ino Sound Bright Blood Glucose Monitoring System (2018), 3 descendants of its own
- K111456: Medisign Blood Glucose Monitoring System (2012), 2 descendants of its own
- K233058: VivaChek Link Plus Blood Glucose Monitoring System (2023), 1 descendant of its own

Source page: https://510kreport.com/device/K000318
Methodology: https://510kreport.com/methodology