FDA Authorization of At-Home Sample Collection for STD Tests Opens 510(k) Pathway
The FDA granted marketing authorization to LetsGetChecked for the first diagnostic test for chlamydia and gonorrhea with at-home sample collection.
The Simple 2 Test, available OTC, is the first FDA-authorized test with at-home sample collection for detection of the presence of the bacteria Chlamydia trachomatis and Neisseria gonorrhoeae.
The user activates the collection kit online, collects the specimen at home, then sends the sample to a laboratory for testing. Results are delivered online, with follow-up from a health care provider in cases of positive or invalid test results.
The FDA reviewed the Simple 2 Test under the FDA’s De Novo premarket review pathway, a regulatory pathway for low- to moderate-risk devices of a new type.
Read the FDA announcement here.
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