# K041016: Nova Glucose Low/High Level Control Solutions

- Pathway: 510(k) (Traditional)
- Applicant: Nova Biomedical Corp.
- Decided: May 7, 2004 after 17 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.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
Nova Glucose Low/High Level Control Solutions are assayed quality control materials, which are used to verify the performance of BD Logic Blood Glucose Monitor, BD Latitude Diabetes Management System, BD/MiniMed Blood Glucose Monitor, and MiniMed Paradigm Link Blood Glucose Monitor. This control is an OTC product intended for use in the home setting. The Nova Glucose Low/High Level Control Solutions are for in vitro diagnostic use ONLY.

Source page: https://510kreport.com/device/K041016
Methodology: https://510kreport.com/methodology