2024-21932. Microbiology Devices; Reclassification of Antigen, Antibody, and Nucleic Acid-Based Hepatitis B Virus Assay Devices

Table 1—Risks to Health and Mitigation Measures for Qualitative HBV Antigen Assays

Identified risks to health	Mitigation measures
False reactive/non-reactive assay result	Certain labeling information, including limitations, explanation of procedures, and results interpretation information.
	Certain design verification and validation information, including certain device description information, risk analysis strategies, lot release criteria, stability studies and protocols, and performance criteria including analytical studies and clinical studies.
Failure to correctly interpret the assay results	Certain labeling information, including warnings, limitations, results interpretation information, and explanation of procedures.
	Certain design verification and validation information, including certain device description information, critical reagent information, risk analysis strategies, lot release criteria, and stability studies and protocols.
Failure to correctly operate the device	Certain labeling information, including warnings, limitations, results interpretation information, and explanation of procedures.
	Certain design verification and validation information, including certain device description, critical reagent information, risk analysis strategies, lot release criteria, and stability studies and protocols.

B. HBV Antibody Assays (Including Qualitative and Quantitative Anti-HBs)

The risk of falsely reactive, non-reactive, elevated, or lowered assay results can be mitigated by special controls requiring certain labeling, including providing clearly stated warnings and limitations and information on principles of operation and procedures in performing the assay.

Risks associated with the failure of the device to perform as indicated ( e.g., false non-reactive and false reactive assay results) can be mitigated through a combination of special controls, including certain labeling requirements, certain design verification and validation information, and performance studies. Examples of verification and validation information to be included in the design of the device include documentation of performance specifications including analytical and clinical performance criteria. In addition, design verification and validation activities must include documentation of a complete device description, critical reagents, risk analysis strategies, lot release criteria, stability studies, and protocols. Required statements in labeling can aid in mitigating the failure of the device to perform as indicated; for example, including a statement that use of the assay with specimen types other than those specifically identified for use with this device may cause inaccurate assay results.

Table 2—Risks to Health and Mitigation Measures for HBV Antibody Assays (Including Qualitative and Quantitative Anti-HBs)

Identified risks to health	Mitigation measures
False reactive/false non-reactive assay result. In addition, for quantitative assays: Falsely elevated/falsely lowered assay result	Certain labeling information, including limitations, explanation of procedures, and results interpretation information. Certain design verification and validation information including certain device description information, risk analysis strategies, lot release criteria, stability studies and protocols, and performance criteria including analytical studies and clinical studies.
Failure to correctly interpret the assay results	Certain labeling information, including warnings, limitations, results interpretation information, and explanation of procedures.
	Certain design verification and validation information including certain device description, critical reagent information, risk analysis strategies, lot release criteria, and stability studies and protocols.
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Failure to correctly operate the devices	Certain labeling information, warnings, limitations, results interpretation information, and explanation of procedures.
	Certain design verification and validation information including certain device description, critical reagent information, risk analysis strategies, lot release criteria, and stability studies and protocols.

C. Quantitative HBV Nucleic Acid-Based Assays

The risk of falsely positive, negative, elevated, or lowered assay results can be mitigated by special controls requiring certain labeling, including providing clearly stated warnings and limitations, device description information, and detailed instructions in the device labeling regarding the interpretation of assay results and principles of operation and procedures in performing the assay.

Risks associated with the failure of the device to perform as indicated ( e.g., inaccurately low or high results, false negative results, and false positive assay results) can be mitigated through a combination of special controls related to certain labeling requirements, design verification and validation activities, and performance studies. Examples of verification and validation information to be included in the design of the device include documentation of a complete device description, calibrators, critical reagents, traceability, and lot release criteria. In addition, design verification and validation must include documentation of performance specifications, including analytical and clinical performance criteria. Required statements in labeling can aid in mitigating the occurrence of inaccurate results. The risks of false positive/false negative/falsely elevated/falsely lowered results due to decreased assay sensitivity can be mitigated by special controls related to certain labeling, design verification and validation activities, risk analysis strategies, and performance studies.

Table 3—Risks to Health and Mitigation Measures for Quantitative HBV Nucleic Acid-Based Assays

Identified risks to health	Mitigation measures
False positive/false negative/falsely elevated/falsely lowered result	Certain labeling information, including limitations, explanation of procedures, and results interpretation information. Certain design verification and validation information, including certain device description information, risk analysis strategies, lot release criteria, stability studies and protocols, and performance criteria including analytical studies and clinical studies.
Failure to correctly interpret the assay results	Certain labeling information, including warnings, limitations, results interpretation information, and explanation of procedures.
	Certain design verification and validation information, including certain device description, critical reagent information, risk analysis strategies, lot release criteria, and stability studies and protocols.
Failure to correctly operate the device	Certain labeling warnings, limitations, results interpretation information, and explanation of procedures.
	Certain design verification and validation information including certain device description, critical reagent information, risk analysis strategies, lot release criteria, and stability studies and protocols.