FDA product code NIJ: System, Test, Genotypic Detection, Resistant Markers, Enterococcus Species
NIJ is the FDA product code for system, test, genotypic detection, resistant markers, enterococcus species. It is a Class II device, regulated under 21 CFR 866.1640 and reviewed by the Microbiology panel. FDA has cleared 6 510(k) submissions under NIJ, 1 in the last five years, from 6 different applicants. The average 510(k) review took 149 days (median 80); 20 days on average over the last three years.
Definition
The in vitro device is intended to detect the presence of the vanA and vanB genes in isolated colonies of Enterococcus spp. as a marker for vancomycin resistance using DNA probe technology
Classification
| Field | Value |
|---|---|
| Device name | System, Test, Genotypic Detection, Resistant Markers, Enterococcus Species |
| Device class | Class II |
| Regulation | 21 CFR 866.1640 |
| Review panel | MI — Microbiology |
| Medical specialty | Microbiology |
| Premarket route | 510(k) |
510(k) clearances per year for NIJ
| Year | Clearances | Avg. review days |
|---|---|---|
| 2024 | 1 | 20 |
Top NIJ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Cepheid® | 1 | 2024-11-21 |
| Intelligent Medical Devices, Inc. | 1 | 2013-07-17 |
| Bd Diagnostics Science | 1 | 2011-10-20 |
| Cepheid | 1 | 2009-12-17 |
| Geneohm Sciences Canada, Inc. | 1 | 2006-08-30 |
1 more applicants have NIJ clearances. See the full list in Caduvo.
Most recent NIJ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K243405 | Cepheid® | Xpert vanA | 2024-11-21 | 20 |
| K123753 | Intelligent Medical Devices, Inc. | IMDX VANR FOR ABBOTT M2000 | 2013-07-17 | 223 |
| K102416 | Bd Diagnostics Science | BD GENEOHM VANR ASSAY | 2011-10-20 | 422 |
| K092953 | Cepheid | Xpert VanA Assay | 2009-12-17 | 84 |
| K061686 | Geneohm Sciences Canada, Inc. | IDI-VANR ASSAY | 2006-08-30 | 76 |
Recalls for NIJ devices
openFDA lists no recalls for product code NIJ.
Frequently asked questions
What is FDA product code NIJ?
NIJ is the FDA product code for system, test, genotypic detection, resistant markers, enterococcus species. It is a Class II device, regulated under 21 CFR 866.1640 and reviewed by the Microbiology panel.
What device class is NIJ?
Class II, regulation 21 CFR 866.1640. Typical premarket route: 510(k).
How long does a 510(k) take for product code NIJ?
Across 6 cleared submissions the average was 149 days from receipt to decision (median 80).
Which companies have the most NIJ clearances?
Cepheid® (1); Intelligent Medical Devices, Inc. (1); Bd Diagnostics Science (1); Cepheid (1); Geneohm Sciences Canada, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code NIJ
- Run a recall and safety report across every NIJ manufacturer
- Watch product code NIJ 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.