FDA product code JXM: Enzyme Immunoassay, Benzodiazepine
JXM is the FDA product code for enzyme immunoassay, benzodiazepine. It is a Class II device, regulated under 21 CFR 862.3170 and reviewed by the Clinical Toxicology panel. FDA has cleared 90 510(k) submissions under JXM, 2 in the last five years, from 42 different applicants. The average 510(k) review took 87 days (median 59); 29 days on average over the last three years. FDA has posted 81 recalls for JXM devices.
Classification
| Field | Value |
|---|---|
| Device name | Enzyme Immunoassay, Benzodiazepine |
| Device class | Class II |
| Regulation | 21 CFR 862.3170 |
| 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 JXM
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 2 | 242 |
| 2018 | 1 | 55 |
| 2019 | 1 | 241 |
| 2022 | 1 | 189 |
| 2024 | 1 | 29 |
Compare with all 510(k) review times · Search every JXM clearance
Top JXM applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Syva Co. | 13 | 2000-01-27 |
| Abbott Laboratories | 8 | 2002-03-13 |
| Roche Diagnostic Systems, Inc. | 7 | 1999-02-11 |
| Healgen Scientific,, LLC | 4 | 2017-08-02 |
| Princeton BioMeditech Corp. | 4 | 1999-04-15 |
37 more applicants have JXM clearances. See the full list in Caduvo.
Most recent JXM clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K243498 | Microgenics Corporation | Alinity c Benzodiazepines Reagent Kit | 2024-12-11 | 29 |
| K221765 | Roche Diagnostics | ONLINE DAT Benzodiazepines II | 2022-12-23 | 189 |
| K190968 | Microgenics Corporation | CEDIA Benzodiazepine Assay | 2019-12-09 | 241 |
| K173963 | Microgenics Corporation | DRI Benzodiazepine Assay | 2018-02-21 | 55 |
| K163590 | Psychemedics Corporation | Psychemedics Microplate EIA for Benzodiazepines in Hair | 2017-09-15 | 269 |
Recalls for JXM devices
81 product recalls in 3 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2020-07-13.
| Year | Recalls |
|---|---|
| 2020 | 2 |
Frequently asked questions
What is FDA product code JXM?
JXM is the FDA product code for enzyme immunoassay, benzodiazepine. It is a Class II device, regulated under 21 CFR 862.3170 and reviewed by the Clinical Toxicology panel.
What device class is JXM?
Class II, regulation 21 CFR 862.3170. Typical premarket route: 510(k).
How long does a 510(k) take for product code JXM?
Across 90 cleared submissions the average was 87 days from receipt to decision (median 59).
Which companies have the most JXM clearances?
Syva Co. (13); Abbott Laboratories (8); Roche Diagnostic Systems, Inc. (7); Healgen Scientific,, LLC (4); Princeton BioMeditech Corp. (4).
Have JXM devices been recalled?
Yes: 81 product recalls across 3 recall events; the most recent began 2020-07-13.
Next steps
- Run an FDA pathway report with predicate devices for product code JXM
- Run a recall and safety report across every JXM manufacturer
- Watch product code JXM 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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