FDA product code MTF: Total, Prostate Specific Antigen (Noncomplexed & Complexed) For Detection Of Prostate Cancer
MTF is the FDA product code for total, prostate specific antigen (noncomplexed & complexed) for detection of prostate cancer. It is a Class III device, reviewed by the Immunology panel. Devices under MTF reach the market by PMA; FDA lists no cleared 510(k)s for it. 12 PMA applications cite this product code. FDA has posted 9 recalls for MTF devices, 1 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Total, Prostate Specific Antigen (Noncomplexed & Complexed) For Detection Of Prostate Cancer |
| Device class | Class III |
| Review panel | IM — Immunology |
| Medical specialty | Unknown |
| Premarket route | PMA |
Recalls for MTF devices
9 product recalls in 7 recall events; 1 initiated in the last five years and 1 still open. Most recent: 2024-09-30.
| Year | Recalls |
|---|---|
| 2024 | 1 |
Frequently asked questions
What is FDA product code MTF?
MTF is the FDA product code for total, prostate specific antigen (noncomplexed & complexed) for detection of prostate cancer. It is a Class III device, reviewed by the Immunology panel.
What device class is MTF?
Class III. Typical premarket route: PMA.
Have MTF devices been recalled?
Yes: 9 product recalls across 7 recall events; the most recent began 2024-09-30.
Next steps
- Run an FDA pathway report with predicate devices for product code MTF
- Run a recall and safety report across every MTF manufacturer
- Watch product code MTF 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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