SGW · Device To Detect Antibodies To Hepatitis D Virus

Immunology · 21 CFR 866.3176 · Class 2

Overview

Identification

The device to detect antibodies to hepatitis D Virus is an in vitro diagnostic device intended for prescription use for the detection of antibodies to the hepatitis D virus (anti-HDV) in human clinical specimens (serum, lithium, sodium heparin, and K2-EDTA plasma). The assay is intended as an aid in the diagnosis of HDV infection in individuals who are at risk for HDV infection, in conjunction with clinical findings and other diagnostic procedures. It is not intended for screening of blood, plasma, cells, or tissue donors.

Classification Rationale

Class II (special controls). FDA has determined that the device can be classified in class II with the establishment of special controls, 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 device to detect antibodies to hepatitis D virus is subject to the following special controls: (1) The labeling required must include: (i) A prominent statement that the assay is not intended for the screening of blood, plasma, cells, or tissue donors. (ii) A detailed explanation of the principles of operation and procedures for performing the assay. (iii) A detailed explanation of interpretation of results. (iv) Limitations, which must be updated to reflect current clinical practice and disease presentation and management. The limitations must include statements that indicate: (A) The specimen types for which the device has been cleared, and that use of the assay with specimen types other than those specifically cleared for this device may result in inaccurate assay results. (B) When appropriate, performance characteristics of the assay have not been established in populations of immunocompromised or immunosuppressed patients or other populations where assay performance may be affected. (C) Detection of HDV antibodies indicates a current or past infection with hepatitis D virus, but does not differentiate between acute, chronic, or resolved infection. (D) Diagnosis of hepatitis D infection should not be established on the basis of a single assay result but should be determined by a licensed healthcare professional in conjunction with clinical presentation, history, and other diagnostic procedures. (E) A non-reactive assay result may occur early during acute infection, prior to development of a host antibody response to infection, or when analyte levels are below the limit of detection of the assay. (F) Results obtained with this assay may not be used interchangeably with results obtained with a different manufacturer's assay. (2) Design verification and validation must include the following: (i) Detailed device description, including all parts that make up the device, ancillary reagents required but not provided, an explanation of the device methodology, and design of the antigen(s) and capture antibody(ies) sequences, rationale for the selected epitope(s), degree of amino acid sequence conservation of the target, and the design and composition of all primary, secondary, and subsequent standards used for calibration. (ii) Documentation and characterization (e.g., supplier, determination of identity, purity and stability) of all critical reagents (including description of the antigen(s) and capture antibody(ies)), and protocols for maintaining product integrity throughout its labeled shelf life. (iii) Risk analysis and management strategies, such as Failure Modes Effects Analysis and/or Hazard Analysis and Critical Control Points summaries and their impact on assay performance. (iv) Stability studies for reagents that include documentation of an assessment of real-time stability for multiple reagent lots using the indicated specimen types and must use acceptance criteria that ensure that analytical and clinical performance characteristics are met when stability is assigned based on the extremes of the acceptance range. (v) Detailed documentation of analytical performance studies and results for determining limit of detection (LoD), cutoff, precision, including lot-to-lot and instrument-to-instrument precision, multi-site reproducibility, interference, cross reactivity, carryover, hook effect, matrix equivalency, specimen stability, reagent stability, and genotype antibody detection sensitivity, when appropriate. (vi) Detailed documentation of acceptable clinical performance testing from a clinical study with an appropriate number of HDV reactive and non-reactive samples in applicable categories and conducted in the appropriate settings by the intended users. Performance must be analyzed relative to an FDA cleared or approved HDV antibody assay or a comparator that FDA has determined is appropriate. Additional relevant patient groups must be validated as appropriate. The samples must include samples for each identified specimen type and, as appropriate, additional characterized clinical samples. Samples must be sourced from geographically diverse areas. This study must be conducted in the appropriate settings by the intended users to demonstrate clinical performance.

Recent Cleared Devices (1 of 1)

Top Applicants

• DiaSorin, Inc. — 1 clearance