Hematology

SFS · Revumenib Eligibility Detection System

Hematology · 21 CFR 864.1885 · Class 2

Overview

Identification

The CDA-LPH013 KMT2A Breakapart FISH Probe Kit PDx is a fluorescence in situ hybridization (FISH) test used to detect rearrangement of the KMT2A region on chromosome 11 at location 11q23.3 in 3:1 methanol/glacial acetic acid fixed bone marrow specimens from patients with acute leukemia with KMT2A rearrangement. It is indicated as a companion diagnostic to aid in identifying patients for whom treatment with REVUFORJ (revumenib) is indicated.

Classification Rationale

FDA has determined that the device can be classified in Class II with the establishment of special controls for class II, which provide reasonable assurance of the safety and effectiveness of the device type.

Special Controls

In combination with the general controls of the FD&C Act, the Revumenib eligibility detection system is subject to the following special controls: (1) Labeling must include: i. A detailed summary of the analytical and clinical performance testing, including results, as required under paragraph (2). ii. The following limiting statements, as appropriate: a. A statement indicating that the test is not intended for monitoring of residual disease, as a prenatal test, or as a population-based screening test; b. A statement indicating that test results are intended to be interpreted by a qualified professional in conjunction with other diagnostic laboratory test results, and should take into consideration other clinical information. (2) Design verification and validation must include: i. Clinical data demonstrating appropriate clinical performance of the device using clinical specimens with structural anomalies of chromosome 11 (e.g., KMT2A rearrangements) representative of the intended use population to identify patients for whom revumenib would be effective, as determined to be appropriate by FDA. ii. Specification of the criteria for test result interpretation and reporting, including device cut-off(s) [i.e., clinical threshold(s) or the medical decision point(s) between positive and negative results] or other relevant criteria that distinguishes positive and negative results. This information must include the rationale for the device cut-off(s) to include the upper reference of normal, or other relevant criteria and results supporting validation of the cut-off(s). Scoring criteria for all applicable signals must be provided. iii. Device performance data demonstrating appropriate reproducibility of the device. The evaluation must include multiple runs, multiple readers, different days, and different reagent lots. Precision of the device must be evaluated per specimen and in aggregate. If the device will be used at more than one site, data must demonstrate adequate reproducibility across multiple intended use sites. Each site included in this study are required to undergo appropriate training of the device and result interpretation in order to demonstrate proficiency. The performance data must include clinical specimens from the intended use specimen type(s), intended use biomarker(s), and specimens near the clinical decision threshold(s). iv. Device performance data demonstrating appropriate analytical sensitivity using interphase nuclei from a sufficient number (e.g., 25) of karyotypically normal male specimens and analytical specificity using metaphase chromosomes from a sufficient number (e.g., 5) of karyotypically normal male specimens. v. Device performance data demonstrating appropriate specimen stability based on the intended use specimen type(s) (e.g., bone marrow) and samples using the indicated specimen collection method(s), as applicable.

Cleared Devices (1)

Top Applicants

• Cytocell Limited — 1 clearance