# K040352: Nova-One Lipid Control (Special Low Interference Liquid Lipid Control)

- Pathway: 510(k) (Traditional)
- Applicant: Bioresource Technology, Inc.
- Decided: Apr 2, 2004 after 50 days
- Product code: JJY (Multi-Analyte Controls, All Kinds (Assayed))
- 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-ONE Control is intended for use in the laboratory to monitor the accuracy and precision of the listed constituents. The routine use of quality control materials is an integral part of evaluating the accuracy and precision of laboratory analysis.

Source page: https://510kreport.com/device/K040352
Methodology: https://510kreport.com/methodology