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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
 
DeviceMediBeacon® Transdermal GFR Measurement System (TGFR)
Generic NameTransdermal test for Assessment of Glomerular Filtration Rate
ApplicantMedibeacon, Inc.
425 N. New Ballas Rd.
Suite 100
St. Louis, MO 63141
PMA NumberP230019
Date Received06/20/2023
Decision Date01/17/2025
Product Code SDK 
Docket Number 25M-0330
Notice Date 01/31/2025
Advisory Committee Gastroenterology/Urology
Clinical TrialsNCT05425719
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for the MediBeacon® Transdermal GFR System (TGFR) intended to assess the Glomerular Filtration Rate (GFR) in adult patients with impaired or normal renal function by noninvasively monitoring fluorescent light emission from an exogenous tracer agent over time. This device has been validated in patients with stable renal function.The MediBeacon® TGFR is not approved for use in patients with GFR <15 ml/min/1.73 m2, GFR >120 ml/min/1.73m2, patients on dialysis, or anuric patients. The use of this device in patients with dynamic and rapidly changing renal function has not been validated. This device is not intended to diagnose acute kidney injury (AKI).The MediBeacon® TGFR Sensor and exogenous tracer agent, Lumitrace® injection, are single use and are only used with the MediBeacon® TGFR. The MediBeacon® TGFR Sensor is a single use device intended to attach to the patient's skin and excite fluorescence in Lumitrace® injection, the tracer agent, and measure the returning light intensity. The data is sent to the MediBeacon® TGFR Monitor. Lumitrace® is an injectable exogenous fluorescent tracer indicated for use with the MediBeacon® Transdermal GFR System (TGFR) for Glomerular Filtration Rate assessment.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Labeling Part 2
Supplements:  S001 S003 
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