DeviceClearance

Product code PIG— Clinical Chemistry

NEPHROCHECK TEST SYSTEM

Classification name
Acute Kidney Injury Test System
Device class
Class 2
Regulation
21 CFR 862.1220
Advisory panel
Clinical Chemistry
Total cleared
5
First cleared
Most recent

FDA classification 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.”

— U.S. Food and Drug Administration, device classification record for product code PIG under 21 CFR 862.1220, via openFDA

Market context for product code PIG

FDA has cleared 5 devices under product code PIG between 2014 and 2023, filed by 3 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

Top applicants under product code PIG

Recent clearances under product code PIG

Data sourced from openFDA. This site is unofficial and independent of the FDA.