FDA product code MXJ: Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-1
MXJ is the FDA product code for enzyme linked immunosorbent assay, herpes simplex virus, hsv-1. It is a Class II device, regulated under 21 CFR 866.3305 and reviewed by the Microbiology panel. FDA has cleared 20 510(k) submissions under MXJ, 2 in the last five years, from 13 different applicants. The average 510(k) review took 179 days (median 150).
Classification
| Field | Value |
|---|---|
| Device name | Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-1 |
| Device class | Class II |
| Regulation | 21 CFR 866.3305 |
| Review panel | MI — Microbiology |
| Medical specialty | Microbiology |
| Premarket route | 510(k) |
510(k) clearances per year for MXJ
| Year | Clearances | Avg. review days |
|---|---|---|
| 2018 | 1 | 94 |
| 2022 | 1 | 195 |
| 2023 | 1 | 639 |
Compare with all 510(k) review times · Search every MXJ clearance
Top MXJ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Focus Diagnostics, Inc. | 3 | 2007-10-05 |
| Biokit, S.A. | 2 | 2023-09-20 |
| Roche Diagnostics | 2 | 2022-10-12 |
| Bio-Rad Laboratories | 2 | 2012-06-22 |
| Zeus Scientific, Inc. | 2 | 2011-04-26 |
8 more applicants have MXJ clearances. See the full list in Caduvo.
Most recent MXJ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K213987 | Biokit, S.A. | ARCHITECT HSV-1 IgG, ARCHITECT HSV-1 IgG Calibrator, ARCHITECT HSV-1 IgG Controls | 2023-09-20 | 639 |
| K220923 | Roche Diagnostics | Elecsys HSV-1 IgG (08948844160) | 2022-10-12 | 195 |
| K181333 | Biokit, S.A. | ADVIA Centaur Herpes-1 IgG | 2018-08-23 | 94 |
| K162276 | Quest International, Inc. | SeraQuest Herpes Type 1 Specific IgG | 2016-10-01 | 50 |
| K143236 | Theranos, Inc. | Theranos Herpes Simplex Virus-1 IgG Assay | 2015-07-02 | 232 |
Recalls for MXJ devices
openFDA lists no recalls for product code MXJ.
Frequently asked questions
What is FDA product code MXJ?
MXJ is the FDA product code for enzyme linked immunosorbent assay, herpes simplex virus, hsv-1. It is a Class II device, regulated under 21 CFR 866.3305 and reviewed by the Microbiology panel.
What device class is MXJ?
Class II, regulation 21 CFR 866.3305. Typical premarket route: 510(k).
How long does a 510(k) take for product code MXJ?
Across 20 cleared submissions the average was 179 days from receipt to decision (median 150).
Which companies have the most MXJ clearances?
Focus Diagnostics, Inc. (3); Biokit, S.A. (2); Roche Diagnostics (2); Bio-Rad Laboratories (2); Zeus Scientific, Inc. (2).
Next steps
- Run an FDA pathway report with predicate devices for product code MXJ
- Run a recall and safety report across every MXJ manufacturer
- Watch product code MXJ 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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