FDA product code NGS: Assay, Endotoxin Activity, Chemiluminescent
NGS is the FDA product code for assay, endotoxin activity, chemiluminescent. It is a Class II device, regulated under 21 CFR 866.3210 and reviewed by the Microbiology panel. FDA has cleared 1 510(k) submission under NGS. The average 510(k) review took 116 days (median 116). 1 De Novo request was granted under it.
Classification
| Field | Value |
|---|---|
| Device name | Assay, Endotoxin Activity, Chemiluminescent |
| Device class | Class II |
| Regulation | 21 CFR 866.3210 |
| Review panel | MI — Microbiology |
| Medical specialty | Microbiology |
| Premarket route | 510(k) |
510(k) clearances per year for NGS
| Year | Clearances | Avg. review days |
|---|---|---|
| 2019 | 1 | 116 |
Compare with all 510(k) review times · Search every NGS clearance
Top NGS applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Spectral Medical, Inc. | 1 | 2019-03-12 |
Most recent NGS clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K183176 | Spectral Medical, Inc. | Endotoxin Activity Assay (EAA) | 2019-03-12 | 116 |
Recalls for NGS devices
openFDA lists no recalls for product code NGS.
Frequently asked questions
What is FDA product code NGS?
NGS is the FDA product code for assay, endotoxin activity, chemiluminescent. It is a Class II device, regulated under 21 CFR 866.3210 and reviewed by the Microbiology panel.
What device class is NGS?
Class II, regulation 21 CFR 866.3210. Typical premarket route: 510(k).
How long does a 510(k) take for product code NGS?
Across 1 cleared submissions the average was 116 days from receipt to decision (median 116).
Which companies have the most NGS clearances?
Spectral Medical, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code NGS
- Run a recall and safety report across every NGS manufacturer
- Watch product code NGS 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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