# K210793: Vidas Nephrocheck

- Pathway: 510(k) (Traditional)
- Applicant: Biomérieux SA
- Decided: Jul 8, 2022 after 479 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
Longest line of descent: 2 generations back to K153165 (2016). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K171482: NEPHROCHECK Test System, Astute Medical, Inc. (2017) Summary page 4.

## Indications for use
VIDAS® NEPHROCHECK® is an automated test for use on the VIDAS® 3 instrument for the immunoenzymatic quantitative determination of TIMP-2 (Tissue Inhibitor of Metalloproteinase-2) and IGFBP-7 (Insulin-like Growth Factor-Binding Protein 7) proteins in human urine using the ELFA technique (Enzyme Linked Fluorescent Assay) for calculation of the AKIRISK™ Score. The VIDAS® NEPHROCHECK® assay 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 VIDAS® NEPHROCHECK® test is intended to be used in patients 21 years of age or older.

Source page: https://510kreport.com/device/K210793
Methodology: https://510kreport.com/methodology