510(k) · Cleared
ClearedAfinion Acr and Acr Control
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Axis-Shield Poc AS · JFY Enzymatic Method, Creatinine
Cleared on Feb 12, 2008 as substantially equivalent to K963142 (Bayer Corp., 1996) after a 169-day review. Its family tree reaches back 1 generation to 1996. 5 later devices descend from it.
- Decided
- Feb 12, 2008
- Review
- 169 days
- Class
- Class II
- Product code
- JFY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K963142 (1996). 5 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK963142 Dca 2000 + Microalbumin/Creatinine AssayBayer Corp. · 1996
- This deviceK072409 Afinion Acr and Acr ControlAxis-Shield Poc AS · 2008
- Descendant · cites it directly · 2 of its ownK171650 Alere Afinion HbA1c and ACR on Afinion 2 analyzerAbbott Rapid Diagnostics · 2017 · Recalled
- Descendant · cites it directly · 1 of its ownK221813 Nova Allegro UACR Assay, Nova Allegro AnalyzerNova Biomedical Corporation · 2024
- Descendant · 2 generations on · 0 of its ownK252206 Nova Allegro UACR Assay, Nova Allegro AnalyzerNova Biomedical Corporation · 2026
- Descendant · 2 generations on · 0 of its ownK221326 Nova Allegro HbA1c Assay, Nova Allegro AnalyzerNova Biomedical Corporation · 2024
- Descendant · 2 generations on · 0 of its ownK214117 Afinion™ HbA1c, Afinion™ 2 and Alere Afinion™ AS100 AnalyzerAbbott Diagnostics Technologies AS · 2023
Most influential descendants
Showing 5 of 5 · See all- K171650Alere Afinion HbA1c and ACR on Afinion 2 analyzerAbbott Rapid Diagnostics · 2017 · cites it directly2descendants
- K221813Nova Allegro UACR Assay, Nova Allegro AnalyzerNova Biomedical Corporation · 2024 · cites it directly1descendant
- K252206Nova Allegro UACR Assay, Nova Allegro AnalyzerNova Biomedical Corporation · 2026 · 2 generations on0descendants
- K221326Nova Allegro HbA1c Assay, Nova Allegro AnalyzerNova Biomedical Corporation · 2024 · 2 generations on0descendants
- K214117Afinion™ HbA1c, Afinion™ 2 and Alere Afinion™ AS100 AnalyzerAbbott Diagnostics Technologies AS · 2023 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K963142 | Dca 2000 + Microalbumin/Creatinine Assay | Bayer Corp. | 1996 | — |
| 0 (this device) | K072409 | Afinion Acr and Acr Control | Axis-Shield Poc AS | 2008 | — |
| +1 | K171650 | Alere Afinion HbA1c and ACR on Afinion 2 analyzer | Abbott Rapid Diagnostics | 2017 | 2 |
| +1 | K221813 | Nova Allegro UACR Assay, Nova Allegro Analyzer | Nova Biomedical Corporation | 2024 | — |
| +2 | K252206 | Nova Allegro UACR Assay, Nova Allegro Analyzer | Nova Biomedical Corporation | 2026 | — |
| +2 | K221326 | Nova Allegro HbA1c Assay, Nova Allegro Analyzer | Nova Biomedical Corporation | 2024 | — |
| +2 | K214117 | Afinion™ HbA1c, Afinion™ 2 and Alere Afinion™ AS100 Analyzer | Abbott Diagnostics Technologies AS | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 2 | 0 |
| 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 JFY? 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 JFY device
- #1 K252619 Qscheck Uisacrscore 12.4 · 6 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 |
|---|---|---|---|
| * | K963142 | Dca 2000 + Microalbumin/Creatinine AssaySummary page 2…Clinical Chemistry Product Code: JJY Substantial Equivalence: Afinion TM ACR is substantial equivalent to the DCA 2000® Microalbumin/Creatinine assay (k963142). These assays yield similar Performance Characteristics. Intended use The AfinionTM ACR assay is an in vitro diagnostic test fo… | 1996 |
What descends from it? (5)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 JFY devicesJFY Enzymatic Method, Creatinine: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
FDA decisions per year · JFY
2in 2021
2026 to Oct 25, outlined.
Median 510(k) review, days · JFY
59in 2009
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JFY
1in 2013
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JFY
61in 2025
MAUDE reports naming product code JFY, 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 | 8 | 193 | 0 | 1 |
| 2008 | 4 | 170 | 2 | 4 |
| 2009 | 3 | 59 | 3 | 22 |
| 2010 | 0 | — | 3 | 22 |
| 2011 | 2 | — | 0 | 42 |
| 2012 | 0 | — | 0 | 24 |
| 2013 | 0 | — | 1 | 39 |
| 2014 | 2 | — | 0 | 4 |
| 2015 | 0 | — | 0 | 7 |
| 2016 | 1 | — | 0 | 16 |
| 2017 | 1 | — | 0 | 16 |
| 2018 | 2 | — | 0 | 34 |
| 2019 | 2 | — | 0 | 56 |
| 2020 | 0 | — | 0 | 34 |
| 2021 | 2 | — | 0 | 57 |
| 2022 | 0 | — | 0 | 9 |
| 2023 | 0 | — | 0 | 36 |
| 2024 | 0 | — | 0 | 34 |
| 2025 | 0 | — | 0 | 61 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
AfinionTM ACR is an in vitro diagnostic test for quantitative determination of albumin, creatinine and albumin/creatinine ratio (ACR) in human urine. The measurement of urine albumin, creatinine and albumin/creatinine ratio aids in the early diagnosis of nephropathy.
AfinionTM ACR Control is a assayed in vitro diagnostic quality control material used to confirm that the AfinionTM ACR and the AfinionTM AS 100 Analyzer System is working properly and provides reliable results
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K072409 · printed Nov 6, 2026
Cite this page
510(k) Report. “K072409: Afinion Acr and Acr Control.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K072409
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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