PIG · Class II — Moderate Risk (510(k) clearance required) · Clinical Chemistry · 21 CFR 862.1220
Classification
FDA Product Code
PIG
Device class
Class II — Moderate Risk (510(k) clearance required)
Regulation
21 CFR 862.1220
Review panel
CH
Medical specialty
Clinical Chemistry
Submission type
1
GMP exempt
N
Life sustaining
N
Implant
N
Third-party review
N
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.