PIG
5 FDA 510(k) clearances · Product code
212 daysmedian time to decision
479 days90th percentile
5clearances measured
FDA profile
- Official device name
- Acute Kidney Injury Test System
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1220
- Medical specialty
- Clinical Chemistry
- FDA 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.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| ProNephro AKI™ (NGAL) (K232761) | Bioporto Diagnostic, Inc. | 2023-12-07 |
| VIDAS NEPHROCHECK (K210793) | Biomérieux SA | 2022-07-08 |
| NEPHROCHECK Test System (K171482) | Astute Medical, Inc. | 2017-11-16 |
| NEPHROCHECK Test Kit, ASTUTE140 Meter, NEPHROCHECK Liquid Controls Kit, NEPHROCHECK Calibration Verification (Cal Vers) Kit (K153165) | Astute Medical, Inc. | 2016-06-01 |
| NEPHROCHECK TEST SYSTEM (DEN130031) | Astute Medical, Inc. | 2014-09-05 |
Track PIG automatically
Every clearance here is in the API, with alerts when new ones post.