Test, Prostate Specific Antigen, Free, (noncomplexed) To Distinguish Prostate Cancer From Benign Conditions

Device Code: 3126

Product Code(s): MTG

Device Classification Information

• Device Type ID: 3126
• Device Name: Test, Prostate Specific Antigen, Free, (noncomplexed) To Distinguish Prostate Cancer From Benign Conditions
• Review Panel: Immunology
• Premarket Review: Office Of In Vitro Diagnostics And Radiological Health (OIR)
• Submission Type: PMA
• FDA Device Classification: Class 3 Medical Device
• Product Code: MTG
• GMP Exempt: No
• Summary MR: Ineligible
• Implanted Device: No
• Life Support Device: No
• Third Party Review: Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

• Device Type ID: 3126
• Device: Test, Prostate Specific Antigen, Free, (noncomplexed) To Distinguish Prostate Cancer From Benign Conditions
• Product Code: MTG
• FDA Device Classification: Class 3 Medical Device

Device Problems
High Test Results	24
Adverse Event Without Identified Device Or Use Problem	8
Incorrect Or Inadequate Test Results	3
Low Test Results	1
Total Device Problems	36

TPLC Last Update: 2019-04-02 20:24:15