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U.S. Department of Health and Human Services

Product Classification

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Device acute kidney injury test system
Regulation Description Acute kidney injury test system.
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.
Physical State The test system may include clinical analyzers, reagents, calibrators, and controls.
Technical Method Assay to measure analyte(s) that are markers of Acute Kidney Injury
Target Area The test system is an in vitro diagnostic device that measures human samples.
Regulation Medical Specialty Clinical Chemistry
Review Panel Clinical Chemistry
Product CodePIG
Premarket Review Division of Chemistry and Toxicology Devices (DCTD)
Division of Chemistry and Toxicology Devices (DCTD)
Submission Type 510(k)
Regulation Number 862.1220
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible