K232761 is an FDA 510(k) clearance for the ProNephro AKI™ (NGAL). This device is classified as a Acute Kidney Injury Test System (Class II - Special Controls, product code PIG).
Submitted by Bioporto Diagnostic, Inc. (Needham, US). The FDA issued a Cleared decision on December 7, 2023, 90 days after receiving the submission on September 8, 2023.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1220. 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..
| 510(k) Number | K232761 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 08, 2023 |
| Decision Date | December 07, 2023 |
| Days to Decision | 90 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
| Product Code | PIG - Acute Kidney Injury Test System |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1220 |
| 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. |