510(k) · Cleared
Recalled · Class II · 2026ProNephro AKI™ (NGAL)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bioporto Diagnostic, Inc. · PIG Acute Kidney Injury Test System
Cleared on Dec 7, 2023 as substantially equivalent to DEN130031 (Astute Medical, Inc., 2014) after a 90-day review. Its family tree reaches back 1 generation to 2014. It has been recalled once.
- Decided
- Dec 7, 2023
- Review
- 90 days
- Class
- Class II
- Product code
- PIG
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 1 generation to DEN130031 (2014). No later device cites it as a predicate yet.
- Root · 1 generation backDEN130031 Nephrocheck Test SystemAstute Medical, Inc. · 2014
- This deviceK232761 ProNephro AKI™ (NGAL)Bioporto Diagnostic, Inc. · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | DEN130031 | Nephrocheck Test System | Astute Medical, Inc. | 2014 | — |
| 0 (this device) | K232761 | ProNephro AKI™ (NGAL) | Bioporto Diagnostic, Inc. | 2023 | — |
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 PIG? 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 PIG device
- #1 K210793 Vidas Nephrocheckscore 3.9 · 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 |
|---|---|---|---|
| * | DEN130031 | Nephrocheck Test SystemSummary page 9…510(k) Summary 10. Substantial Equivalence Information 10.1. Predicate Device Name(s) NEPHROCHECK® Test System 10.2. Predicate 510(k) Number(s) DEN130031 10.3. Comparison With Predicate Table 2: Predicate Device Comparison… | 2014 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 18, 2026 | Class II | Z-2937-2026 | Nonconforming Material/Component | The use of a non-validated rework process for assay reagents which could lead to missed diagnosis of renal disease, inappropriate treatment decisions, or inappropriate monitoring of renal disease in intended users. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has no recall.
How does its category compare?
All PIG devicesPIG Acute Kidney Injury Test System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, this device’s year, is highlighted.
FDA decisions per year · PIG
1in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · PIG
Too few PIG 510(k)s in any year since 2007 to give a median.
Recalls per year · PIG
1so far in 2026, the most since 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · PIG
1in 2024
MAUDE reports naming product code PIG, 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 | 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 | 1 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 1 | — | 0 | 0 |
| 2017 | 1 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 1 | — | 0 | 0 |
| 2023 | 1 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 1 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 1 | — |
What is it indicated for?
Immunoassay for the in vitro quantitative determination of neutrophil gelatinase-associated lipocalin (NGAL) in human urine. Determination of NGAL is intended to be used in conjunction with clinical evaluation in pediatric patients (≥ 3 months to < 22 years) without underlying kidney disease admitted to the intensive care unit (ICU) for the management of cardiovascular or respiratory compromise or who have had a solid organ or bone marrow transplant.…
Read the full statement (187 words)
Immunoassay for the in vitro quantitative determination of neutrophil gelatinase-associated lipocalin (NGAL) in human urine.
Determination of NGAL is intended to be used in conjunction with clinical evaluation in pediatric patients (≥ 3 months to < 22 years) without underlying kidney disease admitted to the intensive care unit (ICU) for the management of cardiovascular or respiratory compromise or who have had a solid organ or bone marrow transplant.
ProNephro AKI™ (NGAL) is intended to be used in the first 24 hours of ICU admission. In patients with low SCr levels, indicative of no acute kidney injury (AKI) or AKI Stage 1, the test can be used as an aid to identify patients at risk to develop moderate to severe AKI (Stage 2/3) 48 to 72 hours after the assessment. In patients with an elevated SCr level, indicative of Stage 2/3 AKI, the test can be used as an aid to identify patients at risk to have persistent moderate to severe AKI (Stage 2/3) 48 to 72 hours after the assessment.
The particle-enhanced turbidimetric immunoassay is intended for use on the Roche cobas c 501 clinical chemistry analyzer.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K232761 · printed Nov 6, 2026
Cite this page
510(k) Report. “K232761: ProNephro AKI™ (NGAL).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K232761
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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