MMW · System, Test, Tumor Marker, Monitoring, Bladder
Immunology · 21 CFR 866.6010 · Class 2
Overview
| Product Code | MMW |
|---|---|
| Device Name | System, Test, Tumor Marker, Monitoring, Bladder |
| 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 (9 of 9)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K203245 | Bladder EpiCheck DNA extraction kit, NX899090-01C, Bladder EpiCheck test kit, NX899090-02C, Bladder EpiCheck Software, NX899090-03C | Nucleix , Ltd. | May 4, 2023 | SESE |
| K033982 | MODIFICATION TO VYSIS UROVYSION BLADDER CANCER RECURRENCE TEST | Vysis | Jan 22, 2004 | SESE |
| K021231 | NMP22 BLADDERCHEK KIT, NMP22 CONTROL KIT | Matritech, Inc. | Jul 30, 2002 | SESE |
| K013785 | UROVYSION BLADDER CANCER RECURRENCE KIT | Vysis | Feb 8, 2002 | SESE |
| K011031 | VYSIS UROVYSION BLADDER CANCER RECURRENCE KIT | Vysis | Aug 3, 2001 | SESE |
| K974845 | BTA STAT TEST PRESCRIPTION HOME USE | Bard Diagnostic Sciences,Inc. | Dec 8, 1998 | SESE |
| K971402 | BARD BTA TRAK TEST | Bard Diagnostic Sciences,Inc. | Apr 15, 1998 | SESE |
| K970353 | AURA TEK FDP | Perimmune, Inc. | Apr 30, 1997 | SESE |
| K964151 | BARD AND BTA TEST | Bard Diagnostic Sciences,Inc. | Apr 16, 1997 | SESE |
Top Applicants
- Bard Diagnostic Sciences,Inc. — 3 clearances
- Vysis — 3 clearances
- Matritech, Inc. — 1 clearance
- Nucleix , Ltd. — 1 clearance
- Perimmune, Inc. — 1 clearance
