MediBeacon Transdermal GFR Measurement System (TGFR)

No FDA recalls found in the data synced 6 Oct 2026.

Full name

MediBeacon® Transdermal GFR Measurement System (GFR)

Trade Name

MediBeacon® Transdermal GFR Measurement System (TGFR)

Generic Name

Transdermal test for Assessment of Glomerular Filtration Rate

PMA Number

P230019 ↗

FDA Product Code

SDK

Device Class

Class III

Advisory Committee

Gastroenterology, Urology

FDA Decision

APPR Approved

• MediBeacon® TGFR Monitor (US) TGFR-MB-01002-001

  Class III

  GUDID on market

• MediBeacon® TGFR Disposable Ring D200

  Class III

  GUDID on market

• MediBeacon® TGFR Reusable Sensor TGFR-SE-00201-001

  Class III

  GUDID on market

• Lumitrace® (relmapirazin) Injection TGFR-TA-00100-010

  Class III

  GUDID on market

• What types of patients is the MediBeacon Transdermal GFR Measurement System designed to monitor, and who should avoid using it?

  The MediBeacon Transdermal GFR Measurement System (TGFR) is designed for adult patients with **stable renal function**, specifically those whose GFR ranges between **15 and 120 ml/min/1.73 m²**. It is **not** intended for patients with GFR below 15, above 120, those on dialysis, or those in anuric conditions. Additionally, it is **not validated** for patients with **rapidly changing renal function** or for diagnosing **acute kidney injury (AKI)**. The system relies on stable tracer kinetics, so dynamic conditions could yield unreliable results.

• How is the MediBeacon Transdermal GFR Measurement System supplied, and is it reusable?

  The system consists of **two single-use components**: the MediBeacon TGFR Sensor (applied to the skin) and the Lumitrace injection (the fluorescent tracer). Neither the sensor nor the tracer can be reused—they are **intended for one-time use only** and must be discarded after a single procedure. The reusable component is the MediBeacon TGFR Monitor, which processes data from the sensor but does not interact directly with patients.

• What is the role of the Lumitrace injection in this system, and how is it administered?

  Lumitrace is an **exogenous fluorescent tracer** injected into the patient’s bloodstream to assess GFR. The MediBeacon TGFR Sensor detects its fluorescence as it passes through the kidneys, enabling noninvasive monitoring. The injection is **single-use** and must be administered **exclusively** with the MediBeacon TGFR System—it is not interchangeable with other devices or tracers.

• What regulatory pathway was followed for FDA authorization of this device, and what does that mean for clinicians?

  The MediBeacon Transdermal GFR Measurement System received **FDA Premarket Approval (PMA)** under PMA number **P230019**, indicating it is classified as a **Class III device** due to its high-risk nature. This means the FDA reviewed clinical data rigorously to confirm safety and effectiveness for its **intended use**: noninvasive GFR assessment in stable adult patients. Clinicians should confirm the device’s **specific exclusion criteria** (e.g., GFR thresholds, dialysis patients) align with their patient population before use.

• How should the MediBeacon TGFR Sensor be stored, and are there any special handling requirements?

  While the device data does not specify storage conditions explicitly, single-use medical sensors like the MediBeacon TGFR Sensor typically require **protection from moisture, extreme temperatures, and contamination** to maintain sterility and functionality. The sensor is **sterile for single-use only**, so it should be stored in its original packaging until immediately before application to avoid compromising integrity. Always follow the manufacturer’s included instructions for proper handling and expiration checks.