Module 19 2021

Intended Purpose and Classification

• Example 1.

Option 1. This is a CLIA for the measurement of hCG concentrations for the diagnosis of pregnancy.

Class B – Rule 6

Option 2. This is a CLIA for the measurement of hCG concentrations for the diagnosis of pregnancy and as an aid in the diagnosis of testicular cancer.

Class C – Rule 3.h

In Option 1, the use for cancer diagnosis it foreseeable misuse: disclaimer required

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