# K091914: Omnis Health Embrace Glucose Control Solution

- Pathway: 510(k) (Traditional)
- Applicant: Bionostics, Inc.
- Decided: Nov 6, 2009 after 129 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: 1 generation back to K090043 (2009). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K090043: Autosure Voice Blood Glucose Monitoring System, Model AS90011F9, Apex BioTechnology Corp. (2009) Summary page 1.

## Most influential descendants
- K133197: Fdi Level I and Level II Glucose Controls for the Embrace NO Code (2014), 0 descendants of its own

## Indications for use
OMNIS Health Embrace Glucose Control Solution is intended to assess the performance of OMNIS Health Embrace Blood Glucose test systems. OMNIS Health Embrace Glucose Control Solution is intended for use by healthcare professionals and people with diabetes mellitus at home.

Source page: https://510kreport.com/device/K091914
Methodology: https://510kreport.com/methodology