FDA product code MTG: Test, Prostate Specific Antigen, Free, (Noncomplexed) To Distinguish Prostate Cancer From Benign Conditions
MTG is the FDA product code for test, prostate specific antigen, free, (noncomplexed) to distinguish prostate cancer from benign conditions. It is a Class III device, reviewed by the Immunology panel. Devices under MTG reach the market by PMA; FDA lists no cleared 510(k)s for it. 8 PMA applications cite this product code. FDA has posted 3 recalls for MTG devices, 1 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Test, Prostate Specific Antigen, Free, (Noncomplexed) To Distinguish Prostate Cancer From Benign Conditions |
| Device class | Class III |
| Review panel | IM — Immunology |
| Medical specialty | Unknown |
| Premarket route | PMA |
Recalls for MTG devices
3 product recalls in 3 recall events; 1 initiated in the last five years and 1 still open. Most recent: 2025-04-24.
| Year | Recalls |
|---|---|
| 2025 | 1 |
Frequently asked questions
What is FDA product code MTG?
MTG is the FDA product code for test, prostate specific antigen, free, (noncomplexed) to distinguish prostate cancer from benign conditions. It is a Class III device, reviewed by the Immunology panel.
What device class is MTG?
Class III. Typical premarket route: PMA.
Have MTG devices been recalled?
Yes: 3 product recalls across 3 recall events; the most recent began 2025-04-24.
Next steps
- Run an FDA pathway report with predicate devices for product code MTG
- Run a recall and safety report across every MTG manufacturer
- Watch product code MTG 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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