LTJ · Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers
Immunology · 21 CFR 866.6010 · Class 2
Overview
| Product Code | LTJ |
|---|---|
| Device Name | Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers |
| Regulation | 21 CFR 866.6010 |
| Device Class | Class 2 |
| Review Panel | Immunology |
| 3rd-Party Reviewable | Yes |
Identification
A tumor-associated antigen immunological test system is a device that consists of reagents used to qualitatively or quantitatively measure, by immunochemical techniques, tumor-associated antigens in serum, plasma, urine, or other body fluids. This device is intended as an aid in monitoring patients for disease progress or response to therapy or for the detection of recurrent or residual disease.
Classification Rationale
Class II (special controls). Tumor markers must comply with the following special controls: (1) A guidance document entitled “Guidance Document for the Submission of Tumor Associated Antigen Premarket Notifications (510(k)s) to FDA,” and (2) voluntary assay performance standards issued by the National Committee on Clinical Laboratory Standards.
Special Controls
*Classification.* Class II (special controls). Tumor markers must comply with the following special controls: (1) A guidance document entitled “Guidance Document for the Submission of Tumor Associated Antigen Premarket Notifications (510(k)s) to FDA,” and (2) voluntary assay performance standards issued by the National Committee on Clinical Laboratory Standards.
Recent Cleared Devices (20 of 37)
Showing 20 most recent of 37 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K251630 | Atellica IM Total PSA II (tPSAII) | Siemens Healthcare Diagnostics, Inc. | Jan 5, 2026 | SESE |
| K162378 | FREND PSA PLUS (reagent cartridge) | Nanoentek USA, Inc. | May 17, 2017 | SESE |
| K124056 | FREND PSA PLUS (REAGENT CARTRIDGE) | Nanoentek, Inc. | May 29, 2013 | SESE |
| K031343 | TPSA FLEX REAGENT CARTRIDGE | Dade Behring, Inc. | May 15, 2003 | SESE |
| K022288 | COMPLEXED PROSTATE SPECIFIC ANTIGEN (CPSA) ASSAY FOR THE BAYER ADVIA INTEGRATED MODULE SYSTEM | Bayer Corp. | Dec 17, 2002 | SESE |
| K022177 | PROSTATE SPECIFIC ANTIGEN (PSA) ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM | Bayer Diagnostics Corp. | Dec 17, 2002 | SESE |
| P000021 | DIMENSION(R) RXL PSA FLEX(R) REAGENT CARTRIDGE | Siemens Healthcare Diagnostics | Jul 5, 2001 | APPR |
| K010550 | VIDAS TOTAL PROSTATE SPECIFIC ANTIGEN (TPSA), MODEL 30 428 | bioMerieux, Inc. | Apr 24, 2001 | SESE |
| K003963 | DIMENSION PSA FLEX REAGENT CARTRIDGE | Dade Behring, Inc. | Feb 28, 2001 | SESE |
| P000027 | ELECSYS FREE PSA IMMUNOASSAY/CALSET/CALCHECK | Roche Diagnostics Corp. | Dec 12, 2000 | APPR |
| K002376 | ADVIA: CENTAUR AND ACS: 180 CPSA ASSAY | Bayer Corp. | Oct 26, 2000 | SESE |
| K003094 | FASTPACK PSA IMMUNOASSAY, FASTPACK ANALYZER | Qualigen, Inc. | Oct 25, 2000 | SESE |
| K002313 | COMPLEXED PSA MICROTITER ELISA | Oncogene Science, Inc. | Aug 30, 2000 | SESE |
| K002121 | TOTAL PSA MICROTITER ELISA | Oncogene Science, Inc. | Aug 30, 2000 | SESE |
| K994419 | FASTPACK PSA IMMUNOASSAY, FASTPACK SYSTEM | Qualisys Diagnostics, Inc. | Jun 28, 2000 | SESE |
| K994221 | BAYER PSA ASSAY | Bayer Corp. | Apr 13, 2000 | SESE |
| K000566 | MODOFICATION TO VITRO IMMUNODIAGNOSTIC PRODUCTS PSA REAGENT PACK, VITRO IMMUNODIAGNOSTIC PRODUCTS PSA CALIBRATORS | Ortho-Clinical Diagnostics, Inc. | Mar 9, 2000 | SESE |
| K990234 | QUALISYS PSA IMMUNOASSAY | Qualisys Diagnostics, Inc. | Jul 8, 1999 | SESE |
| K984289 | VITROS IMMUNODIAGNOSTIC PRODUCTS PSA CALIBRATORS, VITROS IMMUNODIAGNOSTIC PRODUCTS PSA REAGENT PACK | Ortho-Clinical Diagnostics, Inc. | Mar 12, 1999 | SESE |
| P920030 | CIBA CORNING ACS PSA IMMUNOASSAY | Bayer Healthcare, LLC | Dec 8, 1998 | APWD |
Top Applicants
- Boehringer Mannheim Corp. — 5 clearances
- Bayer Corp. — 4 clearances
- Diagnostic Products Corp. — 3 clearances
- Dade Behring, Inc. — 2 clearances
- Diagnostic Systems Laboratories, Inc. — 2 clearances
