# K232761: ProNephro AKI™ (NGAL)

- Pathway: 510(k) (Traditional)
- Applicant: Bioporto Diagnostic, Inc.
- Decided: Dec 7, 2023 after 90 days
- Product code: PIG (Acute Kidney Injury Test System)
- Device class: 2
- Regulation: 21 CFR 862.1220
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to DEN130031 (2014). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- DEN130031: Nephrocheck Test System, Astute Medical, Inc. (2014) Summary page 9.

## Recalls of this device
- May 18, 2026 · Class II · Z-2937-2026: 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 i

## Indications for use
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.

Source page: https://510kreport.com/device/K232761
Methodology: https://510kreport.com/methodology