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U.S. Department of Health and Human Services

Product Classification
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Device transdermal test for assessment of glomerular filtration rate
Definition A test used to assess a patient’s glomerular filtration rate (GFR) by injecting a fluorescent tracer molecule into the blood stream and measuring the amount of fluorescence through the skin with a transdermal sensor.
Physical State The test system may include sensors, software, a monitor, and a molecular tracer agent which is injected into the patient.
Technical Method A tracer is injected into a patient’s blood stream and a sensor is used to measure the tracer signal from the blood through the patient’s skin. This signal is converted to a glomerular filtration rate.
Target Area Kidney or Renal
Review Panel Gastroenterology/Urology
Product CodeSDK
Premarket Review Renal, Gastrointestinal, Obesity and Transplant Devices (DHT3A)
Renal, Gastrointestinal, Obesity and Transplant Devices (DHT3A)
Submission Type PMA
Device Class 3
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting		 Ineligible
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible
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