# DEN130031: Nephrocheck Test System

- Pathway: De Novo (Direct)
- Applicant: Astute Medical, Inc.
- Decided: Sep 5, 2014 after 457 days
- Product code: PIG (Acute Kidney Injury Test System)
- Device class: 2
- Regulation: 21 CFR 862.1220
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. De Novo decisions do not claim a predicate device.

## Most influential descendants
- K232761: ProNephro AKI™ (NGAL) (2023), 0 descendants of its own

## Indications for use
The Astute Medical NEPHROCHECK® Test System is intended to be used in conjunction with clinical evaluation in patients who currently have or have had within the past 24 hours acute cardiovascular and or respiratory compromise and are ICU patients as an aid in the risk assessment for moderate or severe acute kidney injury (AKI) within 12 hours of patient assessment. The NEPHROCHECK® Test System is intended to be used in patients 21 years of age or older.

Source page: https://510kreport.com/device/DEN130031
Methodology: https://510kreport.com/methodology