Transdermal Test For Assessment Of Glomerular Filtration Rate
Basic Information
- Device Name
- Transdermal Test For Assessment Of Glomerular Filtration Rate
- Trade Name
- MediBeacon® Transdermal GFR Measurement System (TGFR)
- PMA Number
- P230019
- Supplement Number
- S002
- Device Class
- FDA Class 3
- Product Code
- SDK
- Generic Name
- Transdermal test for Assessment of Glomerular Filtration Rate
- Medical Specialty
- Unknown
- Advisory Committee
- Gastroenterology, Urology
- Decision
- Approved
- Decision Code
- APPR
- Decision Date
- June 10, 2026
- Date Received
- June 6, 2025
- Supplement Type
- Real-Time Process
- Supplement Reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Expedited Review
- N
Advisory Committee Statement
approval for the following labeling revision: (Prior warning statement) Lumitrace injection may interfere with clinical laboratory tests. The presence of Lumitrace decreased B-Type Natriuretic Peptide (BNP) results by around 20% in limited testing. DO NOT ADMINISTER if the patient is expected to need clinical laboratory testing while Lumitrace is present in their system (up to 72 hours for renally impaired patients).(Revised warning statement) Lumitrace injection may interfere with clinical laboratory tests. DO NOT ADMINISTER if the patient is expected to need clinical laboratory testing while Lumitrace is present in their system, which may be for up to 72 hours.
Classifications
This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| SDK | Transdermal Test For Assessment Of Glomerular Filtration Rate | FDA class 3 | Unknown |