FDA product code NTV: Myeloperoxidase, Immunoassay, System, Test
NTV is the FDA product code for myeloperoxidase, immunoassay, system, test. It is a Class II device, regulated under 21 CFR 866.5600 and reviewed by the Clinical Toxicology panel. FDA has cleared 2 510(k) submissions under NTV, from 2 different applicants. The average 510(k) review took 342 days (median 342). FDA has posted 1 recall for NTV devices.
Definition
MYELOPEROXIDASE, IMMUNOASSAY, SYSTEM, TEST IS INTENDED TO MEASURE MYELOPEROXIDASE IN HUMAN PLASMA, TO BE USED IN CONJUNCTION WITH CLINICAL HISTORY, ECG AND CARDIAC BIOMARKERS TO EVALUATE PATIENTS PRESENTING WITH CHEST PAIN THAT ARE AT RISK FOR MAJOR ADVERSE CARDIAC EVENTS, INCLUDING MYOCARDIAL INFARCTION, NEED FOR REVASCULARIZATION, OR DEATH.
Classification
| Field | Value |
|---|---|
| Device name | Myeloperoxidase, Immunoassay, System, Test |
| Device class | Class II |
| Regulation | 21 CFR 866.5600 |
| Review panel | TX — Clinical Toxicology |
| Medical specialty | Immunology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Compare with all 510(k) review times · Search every NTV clearance
Top NTV applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Siemens Healthcare Diagnostics | 1 | 2008-12-10 |
| Prognostix, Inc. | 1 | 2005-05-10 |
Most recent NTV clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K071474 | Siemens Healthcare Diagnostics | DIMENSION CLINICAL CHEMISTRY SYSTEM MPO FLEX REAGENT CARTRIDGE, CALIBRATOR,CONTROL, MODEL RF425, RC425,RC426 | 2008-12-10 | 561 |
| K050029 | Prognostix, Inc. | CARDIOMPO TEST | 2005-05-10 | 124 |
Recalls for NTV devices
1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2010-12-22.
Frequently asked questions
What is FDA product code NTV?
NTV is the FDA product code for myeloperoxidase, immunoassay, system, test. It is a Class II device, regulated under 21 CFR 866.5600 and reviewed by the Clinical Toxicology panel.
What device class is NTV?
Class II, regulation 21 CFR 866.5600. Typical premarket route: 510(k).
How long does a 510(k) take for product code NTV?
Across 2 cleared submissions the average was 342 days from receipt to decision (median 342).
Which companies have the most NTV clearances?
Siemens Healthcare Diagnostics (1); Prognostix, Inc. (1).
Have NTV devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2010-12-22.
Next steps
- Run an FDA pathway report with predicate devices for product code NTV
- Run a recall and safety report across every NTV manufacturer
- Watch product code NTV 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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