System, Test, Tumor Marker, Monitoring, Bladder
The Bladder Tumor Marker Monitoring Test System is an in vitro diagnostic device used to detect and monitor tumor-associated markers in urine or blood specimens for the detection, surveillance, and management of bladder cancer, providing clinicians with objective biomarker data to guide follow-up decisions in patients with known or suspected bladder malignancy. Classified as a Class 2 device under 21 CFR 866.6010 within the Immunology specialty, it requires 510(k) premarket notification. It carries no implant or life-sustaining flags.
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Basic Information
- Product Code
- MMW
- Device Class
- FDA class 2
- Regulation Number
- 866.6010
- Medical Specialty
- Immunology
- Review Panel
- IM
- Submission Type
- 1
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 9 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K203245 | Bladder EpiCheck DNA extraction kit, NX899090-01C, Bladder EpiCheck test kit, NX899090-02C, Bladder EpiCheck Software, NX899090-03C | May 04, 2023 | Substantially Equivalent | Nucleix , Ltd. |
| K033982 | MODIFICATION TO VYSIS UROVYSION BLADDER CANCER RECURRENCE TEST | Jan 22, 2004 | Substantially Equivalent | Vysis |
| K021231 | NMP22 BLADDERCHEK KIT, NMP22 CONTROL KIT | Jul 30, 2002 | Substantially Equivalent | Matritech, Inc. |
| K013785 | UROVYSION BLADDER CANCER RECURRENCE KIT | Feb 08, 2002 | Substantially Equivalent | Vysis |
| K011031 | VYSIS UROVYSION BLADDER CANCER RECURRENCE KIT | Aug 03, 2001 | Substantially Equivalent | Vysis |
| K974845 | BTA STAT TEST PRESCRIPTION HOME USE | Dec 08, 1998 | Substantially Equivalent | Bard Diagnostic Sciences,Inc. |
| K971402 | BARD BTA TRAK TEST | Apr 15, 1998 | Substantially Equivalent | Bard Diagnostic Sciences,Inc. |
| K970353 | AURA TEK FDP | Apr 30, 1997 | Substantially Equivalent | Perimmune, Inc. |
| K964151 | BARD AND BTA TEST | Apr 16, 1997 | Substantially Equivalent | Bard Diagnostic Sciences,Inc. |
FEI Numbers
This FDA classification entry is associated with 5 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 5 registration numbers. Click on an entry to view related FDA registrations.