FDA product code MJX: Kit, Serological, Positive Control
MJX is the FDA product code for kit, serological, positive control. It is a Class I device, regulated under 21 CFR 862.1660 and reviewed by the Microbiology panel. FDA has cleared 7 510(k) submissions under MJX, from 7 different applicants. The average 510(k) review took 82 days (median 59). FDA has posted 1 recall for MJX devices.
Classification
| Field | Value |
|---|---|
| Device name | Kit, Serological, Positive Control |
| Device class | Class I |
| Regulation | 21 CFR 862.1660 |
| Review panel | MI — Microbiology |
| Medical specialty | Clinical Chemistry |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every MJX clearance
Top MJX applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Aalto Scientific, Ltd. | 1 | 2010-07-22 |
| Ortho-Clinical Diagnostics | 1 | 2003-01-17 |
| Scantibodies Laboratory, Inc. | 1 | 1997-12-24 |
| Boston Biomedica, Inc. | 1 | 1997-10-08 |
| Simplicity Diagnostics, Inc. | 1 | 1997-03-10 |
2 more applicants have MJX clearances. See the full list in Caduvo.
Most recent MJX clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K101434 | Aalto Scientific, Ltd. | AUDIT MICROCV PROCALCITONIN LINEARITY | 2010-07-22 | 62 |
| K030067 | Ortho-Clinical Diagnostics | VITROS IMMUNODIAGNOSTIC PRODUCTS HBSAG CONTROLS | 2003-01-17 | 10 |
| K974262 | Scantibodies Laboratory, Inc. | SYSCOS IDC - G, IDC, BSC, IDC - G | 1997-12-24 | 41 |
| K972986 | Boston Biomedica, Inc. | ACCURUN 140 RUBELLA IGG POSITIVE CONTROL | 1997-10-08 | 58 |
| K970100 | Simplicity Diagnostics, Inc. | TECH SIMPLE SYPHILIS POSITIVE SERUM CONTROL MONITOR ONTRAK SYPHILIS POSITIVE SERUM CONTROL | 1997-03-10 | 59 |
Recalls for MJX devices
1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2016-06-22.
Frequently asked questions
What is FDA product code MJX?
MJX is the FDA product code for kit, serological, positive control. It is a Class I device, regulated under 21 CFR 862.1660 and reviewed by the Microbiology panel.
What device class is MJX?
Class I, regulation 21 CFR 862.1660. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code MJX?
Across 7 cleared submissions the average was 82 days from receipt to decision (median 59).
Which companies have the most MJX clearances?
Aalto Scientific, Ltd. (1); Ortho-Clinical Diagnostics (1); Scantibodies Laboratory, Inc. (1); Boston Biomedica, Inc. (1); Simplicity Diagnostics, Inc. (1).
Have MJX devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2016-06-22.
Next steps
- Run an FDA pathway report with predicate devices for product code MJX
- Run a recall and safety report across every MJX manufacturer
- Watch product code MJX 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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