FDA product code SCX: Immunoassay For Host Biomarkers Of Sepsis
SCX is the FDA product code for immunoassay for host biomarkers of sepsis. It is a Class II device, regulated under 21 CFR 866.3215 and reviewed by the Microbiology panel. FDA has cleared 1 510(k) submission under SCX, 1 in the last five years. The average 510(k) review took 264 days (median 264); 264 days on average over the last three years.
Definition
A semi-quantitative immunoassay that measures the relative levels of host response proteins isolated from host blood or similar specimens.
Classification
| Field | Value |
|---|---|
| Device name | Immunoassay For Host Biomarkers Of Sepsis |
| Device class | Class II |
| Regulation | 21 CFR 866.3215 |
| Review panel | MI — Microbiology |
| Medical specialty | Microbiology |
| Premarket route | 510(k) |
510(k) clearances per year for SCX
| Year | Clearances | Avg. review days |
|---|---|---|
| 2024 | 1 | 264 |
Compare with all 510(k) review times · Search every SCX clearance
Top SCX applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Abionic SA | 1 | 2024-09-25 |
Most recent SCX clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K240041 | Abionic SA | IVD CAPSULE PSP; abioSCOPE | 2024-09-25 | 264 |
Recalls for SCX devices
openFDA lists no recalls for product code SCX.
Frequently asked questions
What is FDA product code SCX?
SCX is the FDA product code for immunoassay for host biomarkers of sepsis. It is a Class II device, regulated under 21 CFR 866.3215 and reviewed by the Microbiology panel.
What device class is SCX?
Class II, regulation 21 CFR 866.3215. Typical premarket route: 510(k).
How long does a 510(k) take for product code SCX?
Across 1 cleared submissions the average was 264 days from receipt to decision (median 264).
Which companies have the most SCX clearances?
Abionic SA (1).
Next steps
- Run an FDA pathway report with predicate devices for product code SCX
- Run a recall and safety report across every SCX manufacturer
- Watch product code SCX 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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