FDA product code MKU: Enzyme Immunoassay, Nicotine And Nicotine Metabolites
MKU is the FDA product code for enzyme immunoassay, nicotine and nicotine metabolites. It is a Class I device, regulated under 21 CFR 862.3220 and reviewed by the Clinical Toxicology panel. FDA has cleared 7 510(k) submissions under MKU, from 5 different applicants. The average 510(k) review took 183 days (median 173).
Classification
| Field | Value |
|---|---|
| Device name | Enzyme Immunoassay, Nicotine And Nicotine Metabolites |
| Device class | Class I |
| Regulation | 21 CFR 862.3220 |
| Review panel | TX — Clinical Toxicology |
| Medical specialty | Clinical Toxicology |
| Premarket route | 510(k) exempt |
510(k) clearances per year for MKU
| Year | Clearances | Avg. review days |
|---|---|---|
| 2019 | 1 | 90 |
| 2020 | 1 | 222 |
Compare with all 510(k) review times · Search every MKU clearance
Top MKU applicants
| Applicant | Clearances | Latest |
|---|---|---|
| OraSure Technologies, Inc. | 3 | 1998-05-18 |
| Psychemedics Corporation | 1 | 2020-04-22 |
| Lin-Zhi International, Inc. | 1 | 2019-11-21 |
| Princeton BioMeditech Corp. | 1 | 2007-02-20 |
| Cozart Bioscience , Ltd. | 1 | 2003-05-14 |
Most recent MKU clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K192517 | Psychemedics Corporation | Psychemedics Microplate EIA for Cotinine in Hair | 2020-04-22 | 222 |
| K192299 | Lin-Zhi International, Inc. | LZI Cotinine II Enzyme Immunoassay | 2019-11-21 | 90 |
| K062565 | Princeton BioMeditech Corp. | STATUS DS NICOTINE, ACCUSIGN NICOTINE, BIOSIGN NICOTINE | 2007-02-20 | 173 |
| K021944 | Cozart Bioscience , Ltd. | COZART EIA COTININE URINE KIT | 2003-05-14 | 335 |
| K974534 | OraSure Technologies, Inc. | MICRO-PLATE COTININE EIA | 1998-05-18 | 167 |
Recalls for MKU devices
openFDA lists no recalls for product code MKU.
Frequently asked questions
What is FDA product code MKU?
MKU is the FDA product code for enzyme immunoassay, nicotine and nicotine metabolites. It is a Class I device, regulated under 21 CFR 862.3220 and reviewed by the Clinical Toxicology panel.
What device class is MKU?
Class I, regulation 21 CFR 862.3220. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code MKU?
Across 7 cleared submissions the average was 183 days from receipt to decision (median 173).
Which companies have the most MKU clearances?
OraSure Technologies, Inc. (3); Psychemedics Corporation (1); Lin-Zhi International, Inc. (1); Princeton BioMeditech Corp. (1); Cozart Bioscience , Ltd. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code MKU
- Run a recall and safety report across every MKU manufacturer
- Watch product code MKU 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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