Laboratory Test Request

FDA Clinical Research Study HRIPT Skin Prick Testing of Medical Device

Project Description

MULTIPLE TESTS
USA FDA GMP Medical Device Laboratory needed for HRIPT skin prick testing of medical device testing with 20 patients.

To address the irritation issue, please be advised to conduct prick and patch tests in humans. For further guidance, please refer to FDA's latest biocompatibility guidnace document available at: Use of International Standard ISO 10993-1, Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process.

Therefore, the test should be conducted with the following protocol.

Skin Prick Testing:
Need to have at least 20 patients complete the study (inclusion and exclusion criteria are the same as in HRIPT)

Visit 1 has an initial screening and if the subject meets the criteria, the skin prick test will be performed. Each test article will have a single administration. Initial reading after 15 mins, looking for the presence or absence of a wheal at all four sites and measuring the diameter of the wheal if present. The wheal at the positive control must exceed a wheal at the negative control by 4 mm. A second reading is conducted about 6 hours after the SPT administration and measurements are taken. The subjects return to the office 1-2 days after the initial administration for a third test reading and measurements.

In conclusion, I leave an inquiry to ask if the test is possible.

Project Information

Number:22-01818

Industry:Medical Devices

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Biologics,Biomaterials,Biopharmaceuticals,Biotechnology,Blood and Blood Products,Clinical Research,Clinical Trials,Home Health Equipment,Immunotherapy and Immunotherapeutics,In-Vitro Diagnostics,Medical Devices,Pharmaceuticals ,

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