# K021697: Glucose Control Solution for BD Latitude

- Pathway: 510(k) (Traditional)
- Applicant: Bionostics, Inc.
- Decided: Jul 12, 2002 after 51 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
Longest line of descent: 2 generations back to K925479 (1993). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K012430: Multi-Meter Glucose Calibration Verification Material, Model Rna GL3, Bionostics, Inc. (2001)

## Indications for use
Glucose Control Solution for BD Latitude™ Blood Glucose Monitoring System is intended for use to verify the performance of the BD Latitude™ BGM System at glucose levels within the reportable range. The Glucose Control Solution is intended for use by healthcare professionals and people with diabetes mellitus at home.

Source page: https://510kreport.com/device/K021697
Methodology: https://510kreport.com/methodology