K210793 is an FDA 510(k) clearance for the VIDAS NEPHROCHECK. This device is classified as a Acute Kidney Injury Test System (Class II - Special Controls, product code PIG).
Submitted by Biom?rieux SA (Marcy L'Etoile, FR). The FDA issued a Cleared decision on July 8, 2022, 479 days after receiving the submission on March 16, 2021.
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 | K210793 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 16, 2021 |
| Decision Date | July 08, 2022 |
| Days to Decision | 479 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. |