# MTF · Total, Prostate Specific Antigen (Noncomplexed & Complexed) For Detection Of Prostate Cancer

_ ·  · Class 3_

**Canonical URL:** https://fda.innolitics.com/productcode/MTF

## Overview

- **Product Code:** MTF
- **Device Name:** Total, Prostate Specific Antigen (Noncomplexed & Complexed) For Detection Of Prostate Cancer
- **Regulation:** 21 CFR N/A
- **Device Class:** 3
- **Review Panel:** [](/submissions/)

## Recent Cleared Devices (8 of 8)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [P240021](/device/P240021.md) | Atellica IM Total PSA II (tPSAII) | Siemens Healthcare Diagnostics, Inc. | Dec 3, 2025 | APPR |
| [P170037](/device/P170037.md) | Sangia Total PSA Test | Opko Diagnostics, LLC | Jan 30, 2019 | APWD |
| [P040008](/device/P040008.md) | VIDAS TPSA ASSAY | bioMerieux, Inc. | Jul 8, 2004 | APWD |
| [P990056](/device/P990056.md) | ELECSYS TOTAL PSA IMMUNOASSAY AND TOTAL PSA CALSET | Roche Diagnostics Corp. | Nov 22, 2000 | APPR |
| [P930027](/device/P930027.md) | IMMULITE SYSTEMS PSA & THIRD GENERATION PSA REAGENTS | Siemens Healthcare Diagnostics, Inc. | Sep 15, 1995 | APPR |
| [P910065](/device/P910065.md) | AIA-PACK PSA | Tosoh Bioscience, Inc. | Jul 7, 1993 | APPR |
| [P910007](/device/P910007.md) | AXSYM TOTAL PSA & ARCHITECT TOTAL PSA | Abbott Laboratories | Sep 25, 1991 | APPR |
| [P850048](/device/P850048.md) | TANDEM-R PSA IMMUNORADIOMETRIC ASSAY | Beckman Coulter, Inc. | Feb 25, 1986 | APPR |

## Top Applicants

- Siemens Healthcare Diagnostics, Inc. — 2 clearances
- Abbott Laboratories — 1 clearance
- Beckman Coulter, Inc. — 1 clearance
- Opko Diagnostics, LLC — 1 clearance
- Roche Diagnostics Corp. — 1 clearance

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**Source:** [https://fda.innolitics.com/productcode/MTF](https://fda.innolitics.com/productcode/MTF)

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