PIGClass II
Acute Kidney Injury Test System
21 CFR 862.1220 / Clinical Chemistry
PIG is the FDA product code for Acute Kidney Injury Test System, a class II device type, regulated under 21 CFR 862.1220. FDA's definition for this code reads: "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...". As of , FDA records hold 5 510(k) clearances under this code, the most recent dated , and one recall.
Classification record
- Product code
- PIG
- Device name
- Acute Kidney Injury Test System
- 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.
- Regulation
- 21 CFR 862.1220
- Device class
- Class II
- Review panel
- Clinical Chemistry
- Submission type
- 510(k)
- Implant
- No
- Life sustaining or supporting
- No
- GMP exempt
- No
- Third party review eligible
- No
- Ingested clearances
- 5
- Ingested recalls
- 1
Clearances, product code PIG
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 2014 | 1 |
| 2016 | 1 |
| 2017 | 1 |
| 2022 | 1 |
| 2023 | 1 |
Applicants with the most clearances
Product code PIG| Applicant | Clearances |
|---|---|
| Astute Medical, Inc. | 3 |
| bioMerieux, Inc. | 1 |
| Bioporto Diagnostic, Inc. | 1 |
Companies listing this code with FDA
Companies whose registered establishments list this codeFIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.