510(k) · Cleared
ClearedNova Allegro UACR Assay, Nova Allegro Analyzer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nova Biomedical Corporation · CGX Alkaline Picrate, Colorimetry, Creatinine
Cleared on Nov 19, 2024 as substantially equivalent to K072409 (Axis-Shield Poc AS, 2008) after an 881-day review. Its family tree reaches back 2 generations to 1996. 1 later device descends from it.
- Decided
- Nov 19, 2024
- Review
- 881 days
- Class
- Class II
- Product code
- CGX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K963142 (1996). 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK963142 Dca 2000 + Microalbumin/Creatinine AssayBayer Corp. · 1996
- 1 generation backK072409 Afinion Acr and Acr ControlAxis-Shield Poc AS · 2008
- This deviceK221813 Nova Allegro UACR Assay, Nova Allegro AnalyzerNova Biomedical Corporation · 2024
- Descendant · cites it directly · 0 of its ownK252206 Nova Allegro UACR Assay, Nova Allegro AnalyzerNova Biomedical Corporation · 2026
Most influential descendants
Showing 1 of 1 · See all- K252206Nova Allegro UACR Assay, Nova Allegro AnalyzerNova Biomedical Corporation · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K963142 | Dca 2000 + Microalbumin/Creatinine Assay | Bayer Corp. | 1996 | — |
| −1 | K072409 | Afinion Acr and Acr Control | Axis-Shield Poc AS | 2008 | — |
| 0 (this device) | K221813 | Nova Allegro UACR Assay, Nova Allegro Analyzer | Nova Biomedical Corporation | 2024 | — |
| +1 | K252206 | Nova Allegro UACR Assay, Nova Allegro Analyzer | Nova Biomedical Corporation | 2026 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2026 | 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 CGX? 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 CGX device
- #1 K242685 Atellica® CH Creatinine_3 (Crea3)score 12.1 · 3 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin 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 |
|---|---|---|---|
| * | K072409 | Afinion Acr and Acr ControlSummary page 5…862.1225 II CGX Analyzer 862.2400 I JQT Predicate Device: K072409 – Afinion ACR and ACR Control Device Description: Nova Allegro UACR Assay The Nova Allegro UACR Assay is a completely automated… | 2008 |
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 |
|---|---|---|---|
| K252206 | Nova Allegro UACR Assay, Nova Allegro Analyzer | 2026 | 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?
- The line of descent spans 28 years and passes through 3 companies; a new generation was cleared every 16.8 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K252206 (Nova Biomedical Corporation, 2026) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K072409.
How does its category compare?
All CGX devicesCGX Alkaline Picrate, Colorimetry, Creatinine: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, this device’s year, is highlighted.
FDA decisions per year · CGX
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · CGX
25in 2007
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · CGX
2in 2016
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · CGX
34in 2025
MAUDE reports naming product code CGX, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 4 | 25 | 0 | 15 |
| 2008 | 0 | — | 1 | 27 |
| 2009 | 1 | — | 2 | 5 |
| 2010 | 0 | — | 2 | 5 |
| 2011 | 0 | — | 1 | 32 |
| 2012 | 1 | — | 2 | 13 |
| 2013 | 1 | — | 0 | 24 |
| 2014 | 2 | — | 0 | 13 |
| 2015 | 0 | — | 0 | 13 |
| 2016 | 1 | — | 2 | 3 |
| 2017 | 0 | — | 0 | 21 |
| 2018 | 0 | — | 0 | 14 |
| 2019 | 0 | — | 0 | 25 |
| 2020 | 0 | — | 0 | 19 |
| 2021 | 0 | — | 0 | 13 |
| 2022 | 1 | — | 0 | 23 |
| 2023 | 0 | — | 0 | 19 |
| 2024 | 2 | — | 0 | 32 |
| 2025 | 1 | — | 0 | 34 |
| 2026 | 1 | — | 1 | — |
What is it indicated for?
The Nova Allegro urine albumin creatinine ratio (UACR) Assay is intended for the quantitative determination of albumin,
creatinine, and the albumin/creatinine ratio (UACR) in human urine. The measurement of urine albumin, creatinine, and
albumin/creatinine ratio aids in the early diagnosis of nephropathy.
The Nova Allegro Analyzer is intended for in vitro diagnostic use in clinical laboratory and near-patient testing (point-of-
care) settings for the quantitative determination of Nova Allegro Assays using Nova Allegro Test Cartridges.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K221813 · printed Nov 6, 2026
Cite this page
510(k) Report. “K221813: Nova Allegro UACR Assay, Nova Allegro Analyzer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K221813
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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