Draft Guidance for Industry and Food and Drug Administration Staff - Class II Special Controls Guidance Document: Nucleic Acid-Based In Vitro Diagnostic Devices for the Detect...
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|U.S. Department of Health and Human Services|
Food and Drug Administration
Center for Devices and Radiological Health
Office of In Vitro Diagnostic Device Evaluation and Safety
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Table of Contents
- Introduction 
- Background 
- Scope 
- Risks to Health 
- Device Description 
- Intended Use
- Test Methodology
- Instrumentation – Hardware and Software
- Negative Controls
- Positive Controls
- Internal Control
- Extraction Control
- Ancillary Reagents
- Testing Procedures Using Your Device
- Interpreting and Reporting Test Results
- Performance Studies 
- General Study Recommendations
- Analytical Studies
- Nucleic acid extraction
- Analytical Reactivity (Inclusivity)
- Analytical Specificity
- Precision Studies
- Specimen Collection, Specimen Storage, and Specimen Shipping Studies
- Device Shipping and Device Storage Studies
- Carry-Over and Cross-contamination Study (for multi-sample assays and devices that require instrumentation)
- Clinical Studies
- Reference Method
- Study Protocols
- Study Sites
- Study Populations
- Data Analysis and Sample Size
- Electronic Data Submission
- Labeling 
- Intended Use
- Device Description
- General Procedure
- Directions for Use
- Quality Control
- Warnings, Contraindications, Precautions, and Limitations
- Specimen Collection
- Interpretation and Reporting of Assay Results
- Performance Characteristics
- References 
Draft Guidance for Industry and Food and Drug Administration Staff - Class II Special Controls Guidance Document: Nucleic Acid-Based In Vitro Diagnostic Devices for the Detection of Mycobacterium tuberculosis Complex in Respiratory Specimens
- Centers for Disease Control and Prevention Fact Sheets - Mycobacterium bovis (Bovine Tuberculosis) in Humans. Division of Tuberculosis Elimination. September 9, 2011. http://www.cdc.gov/tb/publications/factsheets/general/mbovis.htm .
- CR Horsburgh, Jr., Priorities for the Treatment of Latent Tuberculosis Infection in the United States. New England Journal of Medicine, 2004;350:2060-7.
- CDC MMWR, Vol. 60, No. 11 and CDC Reported Tuberculosis in the United States, 2010. Atlanta, GA: US Department of Health and Human Services, CDC, October 2011.
- Clinical and Laboratory Standards Institute. 2006 Molecular Diagnostic Methods for Infectious Disease; Proposed Guideline-Second Edition. MM3-A2. Clinical and Laboratory Standards Institute, Wayne PA.
- Clinical and Laboratory Standards Institute. 2004. Protocol for Determination of Limits of Detection and Limits Quantitation; Approved Guideline. EP17-A. Clinical and Laboratory Standards Institute, Wayne PA.
- Clinical and Laboratory Standards Institute. 2005. Interference Testing in Clinical Chemistry; Approved Guideline-Second Edition. EP07-A2. Clinical and Laboratory Standards Institute, Wayne PA.
- Clinical and Laboratory Standards Institute. 1995. Assessment of the Clinical Accuracy of Laboratory Tests Using Receiver Operating Characteristics (ROC) Plots; Approved Guideline. GP10-A. Clinical and Laboratory Standards Institute, Wayne PA.
- Clinical and Laboratory Standards Institute. 2004. Evaluation of Precision Performance of Quantitative Measurement Methods; Approved Guideline-Second Edition. EP05-A2. Clinical and Laboratory Standards Institute, Wayne PA.
- Clinical and Laboratory Standards Institute. 2008. User Protocol for Evaluation of Qualitative Test Performance; Approved Guideline-Second Edition. EP12-A2. Clinical and Laboratory Standards Institute, Wayne PA.
- Clinical and Laboratory Standards Institute. 2006. User Verification of Performance for Precision and Trueness; Approved Guideline-Second Edition. EP15-A2. Clinical and Laboratory Standards Institute, Wayne PA.
- Clinical and Laboratory Standards Institute. 2005. Collection, Transport, Preparation, and Storage of Specimens for Molecular Methods; Approved Guideline. MM13-A. Clinical and Laboratory Standards Institute, Wayne PA.
- Clinical and Laboratory Standards Institute. 2008. Interpretive Criteria for Identification of Bacteria and Fungi by DNA Target Sequencing; Approved Guideline. MM18-A. Clinical and Laboratory Standards Institute, Wayne PA.
- American Thoracic Society, CDC, and Infectious Diseases Society of America. Treatment of Tuberculosis. American Journal of Respiratory and Critical Care Medicine (2003) 167:603 - 62.
1 M. tuberculosis complex includes the following species: Mycobacterium tuberculosis, M. bovis, M. africanum, M. canetti, M. microti, M. caprae, and M. pinnipedi . The GHTF founding members auditing systems include: the Canadian Medical Devices Conformity Assessment System; Notified Bodies designated by member states of the European Union.; Australian Therapeutics Goods Administration, Office of Manufacturing Quality; and the Japanese Ministry of Health, Labour and Welfare system for Medical Devices and In-vitro Diagnostics.
4 We recommend that the sponsor describe in a pre-submission the number of patients with non-sputum specimens that will be enrolled in the clinical studies. The use of non-sputum specimen types should be supported by analytical studies showing the different matrix has no effect on device performance.
5 Throughout this special controls guidance, the term “processed” or “processing” is used to describe the digestion, decontamination, and centrifugation to pellet of respiratory specimens.
6 These criteria are based on the Sanger di-deoxysequencing method instruments. If you propose other sequencing methods, you should specify the platform and how you will determine acceptable quality.
7 For 200 subjects, 90% (180/200) with 95% two-sided confidence interval: 85.1% to 93.4%