FDA product code MJA: Susceptibility Test Powders, Antimycobacterial
MJA is the FDA product code for susceptibility test powders, antimycobacterial. It is a Class II device, regulated under 21 CFR 866.1640 and reviewed by the Microbiology panel. FDA has cleared 5 510(k) submissions under MJA, from 3 different applicants. The average 510(k) review took 259 days (median 147). FDA has posted 6 recalls for MJA devices, 2 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Susceptibility Test Powders, Antimycobacterial |
| Device class | Class II |
| Regulation | 21 CFR 866.1640 |
| Review panel | MI — Microbiology |
| Medical specialty | Microbiology |
| Premarket route | 510(k) |
Compare with all 510(k) review times · Search every MJA clearance
Top MJA applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Trek Diagnostic Systems, Inc. | 2 | 2006-01-19 |
| Becton, Dickinson & CO | 2 | 2002-07-13 |
| Bd Becton Dickinson Vacutainer Systems Preanalytic | 1 | 2001-06-06 |
Most recent MJA clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K052323 | Trek Diagnostic Systems, Inc. | VERSATREK MYCO PZA KIT | 2006-01-19 | 147 |
| K021582 | Becton, Dickinson & CO | BACTEC MGIT 960 PZA KIT | 2002-07-13 | 60 |
| K014123 | Becton, Dickinson & CO | BACTEC MGIT 960 SIRE KITS | 2002-04-19 | 123 |
| K003062 | Bd Becton Dickinson Vacutainer Systems Preanalytic | BACTEC MGIT 960 SIR KITS | 2001-06-06 | 247 |
| K972772 | Trek Diagnostic Systems, Inc. | ESP CULTURE SYSTEM II - MYCO SUSCEPTIBILITY TESTING | 1999-07-13 | 719 |
Recalls for MJA devices
6 product recalls in 3 recall events; 2 initiated in the last five years and 2 still open. Most recent: 2025-05-20.
| Year | Recalls |
|---|---|
| 2024 | 1 |
| 2025 | 1 |
Frequently asked questions
What is FDA product code MJA?
MJA is the FDA product code for susceptibility test powders, antimycobacterial. It is a Class II device, regulated under 21 CFR 866.1640 and reviewed by the Microbiology panel.
What device class is MJA?
Class II, regulation 21 CFR 866.1640. Typical premarket route: 510(k).
How long does a 510(k) take for product code MJA?
Across 5 cleared submissions the average was 259 days from receipt to decision (median 147).
Which companies have the most MJA clearances?
Trek Diagnostic Systems, Inc. (2); Becton, Dickinson & CO (2); Bd Becton Dickinson Vacutainer Systems Preanalytic (1).
Have MJA devices been recalled?
Yes: 6 product recalls across 3 recall events; the most recent began 2025-05-20.
Next steps
- Run an FDA pathway report with predicate devices for product code MJA
- Run a recall and safety report across every MJA manufacturer
- Watch product code MJA 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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