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.
NEPHROCHECK Test Kit - 500011
Device Description
A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of multiple antigens or markers associated with acute kidney injury (AKI) in a clinical specimen, using a fluorescent immunoassay method. The range of analytes detected may include (but is not limited to) insulin-like growth factor-binding protein 7 (IGFBP-7), neutrophil gelatinase-associated lipocalin (NGAL), tissue-inhibitor of metalloproteinase-2 (TIMP-2), cystatin C, kidney injury molecule-1 (Kim-1) and/or L-type fatty acid–binding protein (L-FABP).
Environmental Conditions
No Data Available
Device Sizes
No Data Available
Device Sterilization
Device Sterile: False
Sterilization Prior To Use: False
Sterilization Methods: No Data Available
Product Codes
Code: PIG
Device Name: Acute Kidney Injury Test System
Device Class: 2
Physical State: The test system may include clinical analyzers, reagents, calibrators, and controls.
Definition: An acute kidney injury test system is intended to measure one or more analytes in human samples as an aid in the assessment of a patient's risk for developing acute kidney injury. Test results are intended to be used in conjunction with other clinical and diagnostic findings, consistent with professional standards of practice, including conifmration by alternative methods.
Submission Type ID: 1
Review Panel: CH
Review Code: N/A
Technical Method: N
Gmp Exempt Flag: Assay to measure analyte(s) that are markers of Acute Kidney Injury
Life Sustain Support Flag: N
Unclassified Reason: N/A
Implant Flag: N
Target Area: The test system is an in vitro diagnostic device that measures human samples.
Regulation Number: 862.1220
Third Party Flag: N
Medical Specialty: CH
Device IdentifiersDevice Id: B0745000110
Device Type: Primary
DeviceId Issuing Agency: HIBCC
Contains DI Number: N/A
Package Quantity: N/A
Package Discontinue Date: N/A
Package Status: N/A
Package Type: N/A