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 Clinica
| Device Type ID | 660 |
| Device Name | Acute Kidney Injury Test System |
| Physical State | The Test System May Include Clinical Analyzers, Reagents, Calibrators, And Controls. |
| Technical Method | Assay To Measure Analyte(s) That Are Markers Of Acute Kidney Injury |
| Target Area | The Test System Is An In Vitro Diagnostic Device That Measures Human Samples. |
| Regulation Description | Acute Kidney Injury Test System. |
| Regulation Medical Specialty | Clinical Chemistry |
| Review Panel | Clinical Chemistry |
| Premarket Review | Office Of In Vitro Diagnostics And Radiological Health (OIR) |
| Submission Type | 510(k) |
| CFR Regulation Number | 862.1220 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | PIG |
| GMP Exempt | No |
| Summary MR | Ineligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 660 |
| Device | Acute Kidney Injury Test System |
| Product Code | PIG |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Acute Kidney Injury Test System. |
| CFR Regulation Number | 862.1220 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
ASTUTE MEDICAL, INC | ||
GRANTED | 1 | |
SUBSTANTIALLY EQUIVALENT | 2 | |