# K133197: Fdi Level I and Level II Glucose Controls for the Embrace NO Code

- Pathway: 510(k) (Traditional)
- Applicant: Fujirebio Diagnostics,Inc.
- Decided: Jan 17, 2014 after 92 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 K090043 (2009). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K091914: Omnis Health Embrace Glucose Control Solution, Bionostics, Inc. (2009) Summary page 1.

## Indications for use
The FDI Glucose Controls are intended for use with Embrace No Code blood glucose meter and test strips. The controls are used to check that the meter and test strips are working together properly. The FDI Glucose Controls for the Embrace No Code are intended for use by healthcare professionals and people with diabetes mellitus at home.

Source page: https://510kreport.com/device/K133197
Methodology: https://510kreport.com/methodology