I think where people are getting confused is with the...

I think where people are getting confused is with the differences between TGA & FDA approvals.

Generally speaking both have a heavy emphasis on safety of a product, But the FDA also looks at the effectiveness of a product where as the TGA doesn't really on this type of product.

I don`t believe there is a concrete threshold for the accuracy, but there needs to be some data to show that the product does what it claims. AKA isnt Disallowed & then consider how safe the product is when used it that manner & the overall net risk/reward so to speak.

IMHO RAP most likely failed as it didn't have enough data to show it works as claimed, PCK is a very different beast.