510(k) · Cleared
ClearedUASure II Blood Uric Acid Monitoring System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Apex BioTechnology Corp. · PTC Uric Acid Test System For At Home Prescription Use
Cleared on Apr 4, 2025 as substantially equivalent to K160990 (Nova Biomedical Corporation, 2017) after a 249-day review. Its family tree reaches back 2 generations to 2005.
- Decided
- Apr 4, 2025
- Review
- 249 days
- Class
- Class I
- Product code
- PTC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K043546 (2005). No later device cites it as a predicate yet.
- Root · 2 generations backK043546 Dimension RXL Max with Streamlab Analytical Workcell and Sample…Dade Behring, Inc. · 2005 · Recalled
- 1 generation backK160990 Nova Max Uric Acid Monitoring SystemNova Biomedical Corporation · 2017
- This deviceK242209 UASure II Blood Uric Acid Monitoring SystemApex BioTechnology Corp. · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K043546 | Dimension RXL Max with Streamlab Analytical Workcell and Sample Transfer Module | Dade Behring, Inc. | 2005 | 3 |
| −1 | K160990 | Nova Max Uric Acid Monitoring System | Nova Biomedical Corporation | 2017 | — |
| 0 (this device) | K242209 | UASure II Blood Uric Acid Monitoring System | Apex BioTechnology Corp. | 2025 | — |
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.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
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 |
|---|---|---|---|
| * | K160990 | Nova Max Uric Acid Monitoring SystemSummary page 5…775 Uric acid test system Classification: Class I, reserved (for PTC) Product Codes: PTC Predicate Devices: Nova Max Uric Acid Monitoring System (K160990) Device Description: The UASure II Blood Uric Acid Monitoring System consists of the UASure II Blood U… | 2017 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- The line of descent spans 20 years and passes through 3 companies; a new generation was cleared every 12.2 years on median.
- 1 of the 2 ancestors has a recall of any class.
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. 2025, 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?
This UASure II Blood Uric Acid Monitoring System measures blood uric acid levels in fresh capillary whole blood drawn from fmgertips. 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. The UASure II Blood Uric Acid Monitoring System helps track uric acid levels but…
Read the full statement (122 words)
This UASure II Blood Uric Acid Monitoring System measures blood uric acid levels in fresh capillary whole blood drawn from fmgertips. 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.
The UASure II Blood Uric Acid Monitoring System helps track uric acid levels but does not diagnose Hyperuricemia or Gout. Do not change medications based on test results without talking to a doctor.
The UASure II Blood Uric Acid Monitoring System includes the UASure II Meter, UASure II Blood Uric Acid Test Strips and UASure II Uric Acid Control Solution.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K242209 · printed Nov 5, 2026
Cite this page
510(k) Report. “K242209: UASure II Blood 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/K242209
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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