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(a) Identification. A prognostic test for assessment of liver related disease progression is intended to measure one or more analytes obtained from human samples as an aid in assessing progression of liver related disease. This device is not intended for diagnosis of any disease, for monitoring the effect of any therapeutic product, for assessing progression to hepatocellular carcinoma, or for assessing disease progression in individuals with viral hepatitis. It is also not intended for the detection of viruses, viral antigens, or antibodies to viruses.
(b) Classification. Class II (special controls). The special controls for this device are:
(1) Design verification and validation must include clinical validation data providing:
(i) Information demonstrating clinical performance in a population of patients with liver disease for the different risk categories (e.g., at lower risk, at higher risk) for progression of their disease using well characterized clinical specimens representing the intended use population collected from multiple intended clinical sites, or an alternative study design determined to be appropriate by FDA.
(ii) Information demonstrating that the outcomes measured and the length of followup are clinically relevant for the progression of the specified liver disease.
(iii) Information demonstrating that the clinical criteria for determining whether the target disease is present and that the exclusion and inclusion criteria for subjects who have the target disease are appropriate.
(iv) Information demonstrating test performance of the complete test system, including any sample collection and processing steps.
(v) Information, provided or referenced, generated in samples from non-diseased individuals, that demonstrate the upper and lower reference intervals for the output provided by the device.
(2) The labeling required under 21 CFR 809.10(b) must include:
(i) A warning statement that test results are not intended to diagnose disease or for monitoring the effect of any therapeutic product.
(ii) A warning statement that test results are intended to be used in conjunction with other clinical and diagnostic findings, consistent with professional standards of practice, including information obtained by alternative methods, and clinical evaluation, as appropriate.
(iii) A warning statement that describes any limitations on the clinical interpretation(s) of the test results.
(iv) Detailed information on device performance, including any limitations to the data generated in the clinical study(ies) and information on device performance in relevant subgroups (e.g., severity of liver disease at the beginning of the observation period) observed in the clinical study(ies).
(v) Information on the analytical performance of the device, including demonstration of reproducibility across multiple sites and multiple reagent lots, or an alternative reproducibility study design determined to be appropriate by FDA.
[88 FR 2599, Jan. 17, 2023]
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