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U.S. Department of Health and Human Services

Product Classification

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Device autonomous extracorporeal blood leak detector/alarm
Regulation Description Hemodialysis system and accessories.
Definition To detect the presence of blood leaking from an extracorporeal connection or needle site in hemodialysis patients and alert the user or attending staff. The device detects colormetric, chemical, or light modulation caused by exposure to leaking blood.
Physical State Small electronic, microprocessor assisted "black box" with a strap that is attached to the patient's arm. The device has visual indicators with accompanying audible alarm
Technical Method An optical fiber is connected to an infrared source at one end and an infrared receiver at the other end. In the middle of the fiber is a sharp bend that is covered with an absorbent pad. Blood absorbed into the pad will cause the intensity of infrared source to decrease at the receiver end and activate an alarm.
Target Area Usually the forearm but could be placed anywhere a blood line and needle are attached to the body.
Regulation Medical Specialty Gastroenterology/Urology
Review Panel Gastroenterology/Urology
Product CodeODX
Premarket Review Office of Gastrorenal, ObGyn, General Hospital, and Urology Devices (OHT3)
Renal, Gastrointestinal, Obesity and Transplant Devices (DHT3A)
Submission Type 510(k)
Regulation Number 876.5820
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible