510(k) · Cleared
ClearedNova Max Uric Acid Monitoring System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nova Biomedical Corporation · PTC Uric Acid Test System For At Home Prescription Use
Cleared on Apr 11, 2017 as substantially equivalent to K043546 (Dade Behring, Inc., 2005) after a 368-day review. Its family tree reaches back 1 generation to 2005. 1 later device descends from it.
- Decided
- Apr 11, 2017
- Review
- 368 days
- Class
- Class I
- Product code
- PTC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K043546 (2005). 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK043546 Dimension RXL Max with Streamlab Analytical Workcell and Sample…Dade Behring, Inc. · 2005 · Recalled
- This deviceK160990 Nova Max Uric Acid Monitoring SystemNova Biomedical Corporation · 2017
- Descendant · cites it directly · 0 of its ownK242209 UASure II Blood Uric Acid Monitoring SystemApex BioTechnology Corp. · 2025
Most influential descendants
Showing 1 of 1 · See all- K242209UASure II Blood Uric Acid Monitoring SystemApex BioTechnology Corp. · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K043546 | Dimension RXL Max with Streamlab Analytical Workcell and Sample Transfer Module | Dade Behring, Inc. | 2005 | 3 |
| 0 (this device) | K160990 | Nova Max Uric Acid Monitoring System | Nova Biomedical Corporation | 2017 | — |
| +1 | K242209 | UASure II Blood Uric Acid Monitoring System | Apex BioTechnology Corp. | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in PTC? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new PTC device
- #1 K242209 UASure II Blood Uric Acid Monitoring Systemscore 9.4 · 2 generations · no Class I recall
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K043546 | Dimension RXL Max with Streamlab Analytical Workcell and Sample Transfer ModuleSummary page 4…ssification: I, reserved Predicate Device: The URCA Method on the Dimension® RxL Max™ Clinical Chemistry System (K043546) Intended Use: The Nova Max Uric Acid Monitoring System consists of Nova Max Uric Acid Monitor, Nova Max Uric Acid Test Strips… | 2005 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K242209 | UASure II Blood Uric Acid Monitoring System | 2025 | 0 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
How does its category compare?
All PTC devicesPTC Uric Acid Test System For At Home Prescription Use: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, this device’s year, is highlighted.
FDA decisions per year · PTC
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · PTC
Too few PTC 510(k)s in any year since 2007 to give a median.
Recalls per year · PTC
No recall names PTC since 2007.
Adverse event reports per year · PTC
No MAUDE report names PTC since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 1 | — | 0 | 0 |
| 2018 | 1 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 1 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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…
Read the full statement (175 words)
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K160990 · printed Nov 5, 2026
Cite this page
510(k) Report. “K160990: Nova Max Uric Acid Monitoring System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K160990
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026