Premarket Approval (PMA)

Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.

• Device: MediBeacon® Transdermal GFR Measurement System (TGFR)
• Generic Name: Transdermal test for Assessment of Glomerular Filtration Rate
• Applicant: Medibeacon, Inc.; 425 N. New Ballas Rd.; Suite 100; St. Louis, MO 63141
• PMA Number: P230019
• Supplement Number: S002
• Date Received: 06/06/2025
• Decision Date: 06/10/2026
• Product Code: SDK
• Advisory Committee: Gastroenterology/Urology
• Supplement Type: Real-Time Process
• Supplement Reason: Labeling Change - Indications/instructions/shelf life/tradename
• Expedited Review Granted?: No
• Combination Product: No
• Predetermined Change Control Plan Authorized: No

Approval Order 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.