# K160990: Nova Max Uric Acid Monitoring System

- Pathway: 510(k) (Traditional)
- Applicant: Nova Biomedical Corporation
- Decided: Apr 11, 2017 after 368 days
- Product code: PTC (Uric Acid Test System For At Home Prescription Use)
- Device class: 1
- Regulation: 21 CFR 862.1775
- 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 K043546 (2005). 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)
- K043546: Dimension RXL Max with Streamlab Analytical Workcell and Sample Transfer Module, Dade Behring, Inc. (2005) Summary page 4.

## Most influential descendants
- K242209: UASure II Blood Uric Acid Monitoring System (2025), 0 descendants of its own

## Indications for use
The Nova Max Uric Acid Monitoring System consists of Nova Max Uric Acid Monitor, Nova Max Uric Acid Test Strips and Nova Max Uric Acid Control Solutions. The Nova Max Uric Acid Monitoring System is intended to be used for the quantitative measurement of Uric Acid in fresh capillary whole blood obtained from the fingertip of gout patients. It is intended for single-patient home use by prescription and should not be shared. It is intended for self-testing outside the body (in vitro diagnostic use) by people with gout as an aid to monitor the effectiveness of Uric Acid control. It is intended for use by patients undergoing treatment for gout or their caregivers on the order of a treating healthcare professional. This system should not be used to alter gout treatment by changing any medication schedule or dosage unless specifically instructed by a healthcare professional. This system should only be used with single-use, auto-disabling Lancing Devices. It should only be used with Nova Max Uric Acid Test Strips and Nova Max Uric Acid Control Solutions.

Source page: https://510kreport.com/device/K160990
Methodology: https://510kreport.com/methodology