FDA product code JXO: Enzyme Immunoassay, Cocaine
JXO is the FDA product code for enzyme immunoassay, cocaine. It is a Class II device, regulated under 21 CFR 862.3250 and reviewed by the Clinical Toxicology panel. FDA has cleared 6 510(k) submissions under JXO, from 5 different applicants. The average 510(k) review took 185 days (median 134).
Classification
| Field | Value |
|---|---|
| Device name | Enzyme Immunoassay, Cocaine |
| Device class | Class II |
| Regulation | 21 CFR 862.3250 |
| Review panel | TX — Clinical Toxicology |
| Medical specialty | Clinical Toxicology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for JXO
| Year | Clearances | Avg. review days |
|---|---|---|
| 2021 | 1 | 414 |
Compare with all 510(k) review times · Search every JXO clearance
Top JXO applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Solarcare Technologies Corp,Inc. | 2 | 1992-08-20 |
| Psychemedics Corporation | 1 | 2021-06-25 |
| Psychemedics Corp. | 1 | 2012-05-01 |
| Serex, Inc. | 1 | 1992-08-24 |
| Instrumentation Laboratory CO | 1 | 1991-12-03 |
Most recent JXO clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K201228 | Psychemedics Corporation | Psychemedics Homogeneous Enzyme Immunoassay for Cocaine in Hair | 2021-06-25 | 414 |
| K111925 | Psychemedics Corp. | PSYCHEMEDICS COCAINE EIA | 2012-05-01 | 300 |
| K923314 | Serex, Inc. | AUTOMATES COMA PLUS COCAINE METABOLITE ASSAY | 1992-08-24 | 48 |
| K921140 | Solarcare Technologies Corp,Inc. | STC DIAGNOSTICS AUTO0LYTE COCAINE METABOLITE EIA | 1992-08-20 | 163 |
| K915785 | Solarcare Technologies Corp,Inc. | STC DIAGNOSTICS BENZOYLECGONINE EIA | 1992-03-11 | 78 |
Recalls for JXO devices
openFDA lists no recalls for product code JXO.
Frequently asked questions
What is FDA product code JXO?
JXO is the FDA product code for enzyme immunoassay, cocaine. It is a Class II device, regulated under 21 CFR 862.3250 and reviewed by the Clinical Toxicology panel.
What device class is JXO?
Class II, regulation 21 CFR 862.3250. Typical premarket route: 510(k).
How long does a 510(k) take for product code JXO?
Across 6 cleared submissions the average was 185 days from receipt to decision (median 134).
Which companies have the most JXO clearances?
Solarcare Technologies Corp,Inc. (2); Psychemedics Corporation (1); Psychemedics Corp. (1); Serex, Inc. (1); Instrumentation Laboratory CO (1).
Next steps
- Run an FDA pathway report with predicate devices for product code JXO
- Run a recall and safety report across every JXO manufacturer
- Watch product code JXO 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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