Acute Kidney Injury Test System
The Acute Kidney Injury Test System is a clinical chemistry device intended to measure one or more analytes in human samples as an aid in assessing a patient's risk for developing acute kidney injury, with results used in conjunction with other clinical and diagnostic findings. It is an FDA Class 2 device regulated under 21 CFR 862.1220, requiring 510(k) premarket notification, within the Clinical Chemistry (CH) medical specialty. The product code is PIG. This device is not implantable and is not life-sustaining.
Basic Information
- Product Code
- PIG
- Device Class
- FDA class 2
- Regulation Number
- 862.1220
- Medical Specialty
- Clinical Chemistry
- Review Panel
- CH
- Submission Type
- 1
Device Characteristics
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.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 5 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K232761 | ProNephro AKI (NGAL) | Dec 07, 2023 | Substantially Equivalent | Bioporto Diagnostic, Inc. |
| K210793 | VIDAS NEPHROCHECK | Jul 08, 2022 | Substantially Equivalent | Biomérieux SA |
| K171482 | NEPHROCHECK Test System | Nov 16, 2017 | Substantially Equivalent | Astute Medical, Inc. |
| K153165 | NEPHROCHECK Test Kit, ASTUTE140 Meter, NEPHROCHECK Liquid Controls Kit, NEPHROCHECK Calibration Verification (Cal Vers) Kit | Jun 01, 2016 | Substantially Equivalent | Astute Medical, Inc. |
| DEN130031 | NEPHROCHECK TEST SYSTEM | Sep 05, 2014 | Unknown | Astute Medical, Inc. |
FEI Numbers
This FDA classification entry is associated with 2 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 2 registration numbers. Click on an entry to view related FDA registrations.