FDA product code MRS: Test System, Nicotine, Cotinine, Metabolites
MRS is the FDA product code for test system, nicotine, cotinine, metabolites. It is a Class I device, regulated under 21 CFR 862.3220 and reviewed by the Clinical Toxicology panel. FDA has cleared 3 510(k) submissions under MRS, from 3 different applicants. The average 510(k) review took 107 days (median 88). FDA has posted 1 recall for MRS devices.
Classification
| Field | Value |
|---|---|
| Device name | Test System, Nicotine, Cotinine, Metabolites |
| Device class | Class I |
| Regulation | 21 CFR 862.3220 |
| Review panel | TX — Clinical Toxicology |
| Medical specialty | Clinical Toxicology |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every MRS clearance
Top MRS applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Microgenics Corp. | 1 | 2003-05-22 |
| Nymox Pharmaceutical Corporation | 1 | 2002-10-18 |
| Dynagen, Inc. | 1 | 1996-12-13 |
Most recent MRS clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K030649 | Microgenics Corp. | DRI COTININE EIA ASSAY | 2003-05-22 | 83 |
| K021688 | Nymox Pharmaceutical Corporation | NICALERT | 2002-10-18 | 149 |
| K963733 | Dynagen, Inc. | NICCHECK I | 1996-12-13 | 88 |
Recalls for MRS devices
1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2020-01-21.
| Year | Recalls |
|---|---|
| 2020 | 1 |
Frequently asked questions
What is FDA product code MRS?
MRS is the FDA product code for test system, nicotine, cotinine, metabolites. It is a Class I device, regulated under 21 CFR 862.3220 and reviewed by the Clinical Toxicology panel.
What device class is MRS?
Class I, regulation 21 CFR 862.3220. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code MRS?
Across 3 cleared submissions the average was 107 days from receipt to decision (median 88).
Which companies have the most MRS clearances?
Microgenics Corp. (1); Nymox Pharmaceutical Corporation (1); Dynagen, Inc. (1).
Have MRS devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2020-01-21.
Next steps
- Run an FDA pathway report with predicate devices for product code MRS
- Run a recall and safety report across every MRS manufacturer
- Watch product code MRS 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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