https://labtestsonline.org/articles/commercial-tests-fda-approval
I'm no expert but from what I can see here (see link) it really depends on the type of test.
Tests which fall in the 'Class I' category may even be exempt from FDA assessment. Tests that fall in Class III (based on the examples this site gives i think the BD1 test is in this category) have more stringent requiements, do require FDA approval and would likely take considerably more time.
Chart, page-3278
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