In Vitro Diagnostic Devices for Detection of Parvovirus B19 Antibodies in Human Serum and Plasma
This guidance provides criteria for premarket approval of in vitro diagnostic devices intended for qualitative or semi-quantitative measurement of antibodies to Parvovirus B19 in human serum or plasma using immunochemical and other methodologies.
Recommended Actions
- Develop comprehensive clinical testing protocol across 3 independent sites
- Conduct complete analytical validation studies
- Perform cross-reactivity testing with specified viral antibodies
- Document stability data from 3 different manufactured lots
- Prepare detailed labeling including all required sections
- Establish quality control procedures compliant with CLIA ‘88
- Generate performance data for different patient populations
- Validate all specimen types claimed for use
- Document software validation if applicable
- Prepare comprehensive documentation of reproducibility studies
Key Considerations
Clinical testing
- Testing must be performed at 3 independent sites not affiliated with manufacturer
- Must test samples from patients with symptoms of B19 infection
- Clinical confirmation through:
- Clinical diagnosis based on specific criteria
- Immune electron microscopy
- Other standard methods
- Testing required for sera from diseases with similar symptoms (Kawasaki, aplastic anemia, etc.)
- Optional testing of well-documented panels (e.g. CDC panel)
Non-clinical testing
- Analytical laboratory studies required for:
- Cut-off validation
- Prevalence studies in asymptomatic populations
- Assay specificity
- Interference studies
- Reproducibility testing
- Stability studies
Software
- Requirements for Minor Level of concern per FDA Reviewer Guidance for computer-controlled devices
- Must provide algorithms for result calculations
- Documentation needed for dedicated instrumentation
Labelling
- Must include:
- Intended use statement
- Test methodology
- Specimen collection/handling instructions
- Quality control procedures
- Expected results
- Test limitations
- Performance characteristics
Other considerations
- Cross-reactivity studies required with other viral antibodies
- Stability testing under various storage and shipping conditions
- Documentation of reproducibility across different lots
Relevant Guidances
- Migration Studies for In Vitro Diagnostic Devices Moving to New Systems
- In Vitro Diagnostic Devices for Detection of Antibodies to Borrelia burgdorferi - Performance Characteristics and Testing Requirements
- In Vitro Diagnostic Device Studies Exempt from Investigational Device Exemption Requirements
- Use of Leftover Human Specimens in IVD Device Studies: Requirements for IDE Exemption and Privacy Protection
- Administrative Procedures for CLIA Categorization of In Vitro Diagnostic Tests
Related references and norms
- NCCLS I/LA 18-P: Specifications for immunological testing for infectious diseases
- NCCLS EP5-T2: Evaluation of precision performance of clinical chemistry devices
Original guidance
- In Vitro Diagnostic Devices for Detection of Parvovirus B19 Antibodies in Human Serum and Plasma
- HTML / PDF
- Issue date: 1992-05-15
- Last changed date: 2020-03-17
- Status: FINAL
- Official FDA topics: Medical Devices, Laboratory Tests, Premarket, IVDs (In Vitro Diagnostic Devices)
- ReguVirta summary file ID: ab25b264d7d51969ea28da2010c195b7
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