FDA product code NTI: Drug Metabolizing Enzyme Genotyping Systems
NTI is the FDA product code for drug metabolizing enzyme genotyping systems. It is a Class II device, regulated under 21 CFR 862.3360 and reviewed by the Clinical Toxicology panel. FDA has cleared 10 510(k) submissions under NTI, 1 in the last five years, from 7 different applicants. The average 510(k) review took 182 days (median 154). 1 De Novo request was granted under it. FDA has posted 4 recalls for NTI devices.
Definition
Intended to identify the presence or absence of human genotypic markers encoding drug metaboizing enzymes using dna originating from clinical samples. This type of assay can be used as an aid determining treatment choice and individualizing treatment dose for therapeutics that are metabolized primarily by the specific enzyme tested by the system.
Classification
| Field | Value |
|---|---|
| Device name | Drug Metabolizing Enzyme Genotyping Systems |
| Device class | Class II |
| Regulation | 21 CFR 862.3360 |
| Review panel | TX — Clinical Toxicology |
| Medical specialty | Clinical Toxicology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for NTI
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 1 | 175 |
| 2023 | 1 | 440 |
Compare with all 510(k) review times · Search every NTI clearance
Top NTI applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Luminex Molecular Diagnostics, Inc. | 4 | 2017-08-11 |
| Genomadix, Inc. | 1 | 2023-03-21 |
| Spartan Bioscience, Inc. | 1 | 2013-08-12 |
| Nanosphere, Inc. | 1 | 2012-11-06 |
| Autogenomics, Incorporated | 1 | 2010-10-25 |
2 more applicants have NTI clearances. See the full list in Caduvo.
Most recent NTI clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K220026 | Genomadix, Inc. | Genomadix Cube CYP2C19 System | 2023-03-21 | 440 |
| K170492 | Luminex Molecular Diagnostics, Inc. | xTAG CYP2D6 Kit v3 | 2017-08-11 | 175 |
| K131565 | Luminex Molecular Diagnostics, Inc. | XTAG CYP2C19 KIT V3 | 2013-09-11 | 104 |
| K123891 | Spartan Bioscience, Inc. | SPARTAN RX CYP2C19 TEST SYSTEM | 2013-08-12 | 237 |
| K130189 | Luminex Molecular Diagnostics, Inc. | XTAG CYP2D6 KIT V3 (INCLUDING TDAS CYP2D6 SOFTWARE) | 2013-05-21 | 116 |
Recalls for NTI devices
4 product recalls in 3 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2014-03-18.
Frequently asked questions
What is FDA product code NTI?
NTI is the FDA product code for drug metabolizing enzyme genotyping systems. It is a Class II device, regulated under 21 CFR 862.3360 and reviewed by the Clinical Toxicology panel.
What device class is NTI?
Class II, regulation 21 CFR 862.3360. Typical premarket route: 510(k).
How long does a 510(k) take for product code NTI?
Across 10 cleared submissions the average was 182 days from receipt to decision (median 154).
Which companies have the most NTI clearances?
Luminex Molecular Diagnostics, Inc. (4); Genomadix, Inc. (1); Spartan Bioscience, Inc. (1); Nanosphere, Inc. (1); Autogenomics, Incorporated (1).
Have NTI devices been recalled?
Yes: 4 product recalls across 3 recall events; the most recent began 2014-03-18.
Next steps
- Run an FDA pathway report with predicate devices for product code NTI
- Run a recall and safety report across every NTI manufacturer
- Watch product code NTI 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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