§ 862.1223 — Prognostic test for assessment of chronic kidney disease progression.

§ 862.1223 Prognostic test for assessment of chronic kidney disease progression.

(a) Identification. A prognostic test for assessment of chronic kidney disease progression is an in vitro diagnostic device intended to measure one or more analytes obtained from human samples as an aid in assessing the risk for progression of chronic kidney disease. This device is not intended for diagnosis of any disease, for serial monitoring of kidney disease progression, or for monitoring the effect of any therapeutic product.

(b) Classification. Class II (special controls). The special controls for this device are:

(1) Design verification and validation must include:

(i) Detailed documentation of a clinical study that includes the following:

(A) Information that demonstrates the clinical performance of the device in a population of patients with chronic kidney disease at the different reported risk categories for progression of their disease (e.g., at lower risk, at increased risk) using samples from the intended use population collected from multiple intended sample collection sites, or through an alternative approach determined to be appropriate by FDA;

(B) Information that demonstrates the measured outcomes and the length of follow-up are clinically relevant to demonstrate the progression of the chronic kidney disease; and

(C) A description of subjects from the target population (e.g., the severity of underlying disease) and any exclusion or inclusion criteria.

(ii) Detailed documentation of a reference interval study that includes:

(A) Data generated in samples from healthy individuals; and

(B) Estimation of the upper and lower limits of the reference intervals and percentages of healthy individuals in each device-identified risk category.

(iii) When appropriate, detailed information that demonstrates the precision of the numeric values of the device output (score) based on the precision profiles of each individual input.

(iv) When appropriate, detailed information on the impact of the cumulative effect of potential interferents on the numeric values of the device output (score) based on the information known or determined for the potential of interference for each individual input.

(2) The labeling required under § 809.10(b) of this chapter must include:

(i) Limiting statements indicating that:

(A) The test results are not intended to diagnose any disease or condition;

(B) The 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; and

(C) The device is not intended for serial monitoring of kidney disease progression or for monitoring the effect of any therapeutic product.

(ii) Limiting statements, where applicable, describing the limitations on the clinical interpretations of the test results.

(iii) Limiting statements, where applicable, describing the limitations to the data generated in the clinical study(ies).

(iv) Detailed information on device performance in relevant subgroups (e.g., severity of chronic kidney disease determined at the beginning of the observation period in the clinical study).

[91 FR 46715, July 24, 2026]