FDA product code PIG: Acute Kidney Injury Test System
PIG is the FDA product code for acute kidney injury test system. It is a Class II device, regulated under 21 CFR 862.1220 and reviewed by the Clinical Chemistry panel. FDA has cleared 4 510(k) submissions under PIG, 2 in the last five years, from 3 different applicants. The average 510(k) review took 240 days (median 196). 1 De Novo request was granted under it. FDA has posted 1 recall for PIG devices, 1 initiated in the last five years.
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.
Classification
| Field | Value |
|---|---|
| Device name | Acute Kidney Injury Test System |
| Device class | Class II |
| Regulation | 21 CFR 862.1220 |
| Review panel | CH — Clinical Chemistry |
| Medical specialty | Clinical Chemistry |
| Premarket route | 510(k) |
510(k) clearances per year for PIG
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 1 | 181 |
| 2022 | 1 | 479 |
| 2023 | 1 | 90 |
Compare with all 510(k) review times · Search every PIG clearance
Top PIG applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Astute Medical, Inc. | 2 | 2017-11-16 |
| Bioporto Diagnostic, Inc. | 1 | 2023-12-07 |
| Biomérieux SA | 1 | 2022-07-08 |
Most recent PIG clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K232761 | Bioporto Diagnostic, Inc. | ProNephro AKI (NGAL) | 2023-12-07 | 90 |
| K210793 | Biomérieux SA | VIDAS NEPHROCHECK | 2022-07-08 | 479 |
| K171482 | Astute Medical, Inc. | NEPHROCHECK Test System | 2017-11-16 | 181 |
| K153165 | Astute Medical, Inc. | NEPHROCHECK Test Kit, ASTUTE140 Meter, NEPHROCHECK Liquid Controls Kit, NEPHROCHECK Calibration Verification (Cal Vers) Kit | 2016-06-01 | 212 |
Recalls for PIG devices
1 product recalls in 1 recall events; 1 initiated in the last five years and 1 still open. Most recent: 2026-05-18.
| Year | Recalls |
|---|---|
| 2026 | 1 |
Frequently asked questions
What is FDA product code PIG?
PIG is the FDA product code for acute kidney injury test system. It is a Class II device, regulated under 21 CFR 862.1220 and reviewed by the Clinical Chemistry panel.
What device class is PIG?
Class II, regulation 21 CFR 862.1220. Typical premarket route: 510(k).
How long does a 510(k) take for product code PIG?
Across 4 cleared submissions the average was 240 days from receipt to decision (median 196).
Which companies have the most PIG clearances?
Astute Medical, Inc. (2); Bioporto Diagnostic, Inc. (1); Biomérieux SA (1).
Have PIG devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2026-05-18.
Next steps
- Run an FDA pathway report with predicate devices for product code PIG
- Run a recall and safety report across every PIG manufacturer
- Watch product code PIG for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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