FDA product code MVO: Kit, Test, Multiple, Drugs Of Abuse, Over The Counter
MVO is the FDA product code for kit, test, multiple, drugs of abuse, over the counter. It is a Unclassified device, reviewed by the Clinical Toxicology panel. FDA has cleared 18 510(k) submissions under MVO, from 6 different applicants. The average 510(k) review took 62 days (median 52). FDA has posted 1 recall for MVO devices, 1 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Kit, Test, Multiple, Drugs Of Abuse, Over The Counter |
| Device class | Unclassified |
| Review panel | TX — Clinical Toxicology |
| Medical specialty | Unknown |
| Premarket route | 510(k) |
Compare with all 510(k) review times · Search every MVO clearance
Top MVO applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Phamatech | 11 | 2003-04-14 |
| Phamatech, Inc. | 3 | 2001-12-06 |
| Accu-Stat Diagnostics, Inc. | 1 | 2004-04-19 |
| Princeton BioMeditech Corp. | 1 | 2002-05-23 |
| Advantage Diagnostics Corp. | 1 | 2002-02-07 |
1 more applicants have MVO clearances. See the full list in Caduvo.
Most recent MVO clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K040327 | Accu-Stat Diagnostics, Inc. | ACCU-STAT HOME DRUG TESTS FOR MARIJUANA (THC) AND FOR MARIJUANA & COCAINE (THC, COC) | 2004-04-19 | 69 |
| K030447 | Phamatech | AT HOME DRUG CUP, MODEL 9150X | 2003-04-14 | 62 |
| K014192 | Princeton BioMeditech Corp. | LIFESIGN MET, STATUS STIK MET, ACCUSIGN STIK MET, ACCUSTIK MET, ACCUSIGN MET, STATUS DS MET | 2002-05-23 | 153 |
| K013778 | Advantage Diagnostics Corp. | PEACE OF MIND HOME DRUG TEST | 2002-02-07 | 86 |
| K013412 | Phamatech, Inc. | AT HOME DRUG TEST, MODEL 9069 | 2001-12-06 | 52 |
Recalls for MVO devices
1 product recalls in 1 recall events; 1 initiated in the last five years and 1 still open. Most recent: 2026-04-02.
| Year | Recalls |
|---|---|
| 2026 | 1 |
Frequently asked questions
What is FDA product code MVO?
MVO is the FDA product code for kit, test, multiple, drugs of abuse, over the counter. It is a Unclassified device, reviewed by the Clinical Toxicology panel.
What device class is MVO?
Unclassified. Typical premarket route: 510(k).
How long does a 510(k) take for product code MVO?
Across 18 cleared submissions the average was 62 days from receipt to decision (median 52).
Which companies have the most MVO clearances?
Phamatech (11); Phamatech, Inc. (3); Accu-Stat Diagnostics, Inc. (1); Princeton BioMeditech Corp. (1); Advantage Diagnostics Corp. (1).
Have MVO devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2026-04-02.
Next steps
- Run an FDA pathway report with predicate devices for product code MVO
- Run a recall and safety report across every MVO manufacturer
- Watch product code MVO 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.
All Clinical Toxicology product codes · FDA product code lookup · 510(k) database search · 510(k) review times