PIG — Acute Kidney Injury Test System Class II
Classification Details
- Product Code
- PIG
- Device Class
- Class II
- Regulation Number
- 862.1220
- Submission Type
- Review Panel
- CH
- Medical Specialty
- Clinical Chemistry
- Implant
- No
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.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K232761 | bioporto diagnostic | ProNephro AKI (NGAL) | December 7, 2023 |
| K210793 | biomérieux | VIDAS NEPHROCHECK | July 8, 2022 |
| K171482 | astute medical | NEPHROCHECK Test System | November 16, 2017 |
| K153165 | astute medical | NEPHROCHECK Test Kit, ASTUTE140 Meter, NEPHROCHECK Liquid Controls Kit, NEPHROCH | June 1, 2016 |
| DEN130031 | astute medical | NEPHROCHECK TEST SYSTEM | September 5, 2014 |