Early Growth Response 1 (EGR1) Gene Fluorescence In-Situ Hybridization Test Systems for Bone Marrow Specimens
This guidance covers Early Growth Response 1 (EGR1) Gene Fluorescence In-Situ Hybridization (FISH) Test Systems intended to detect EGR1 probe target on chromosome 5q in bone marrow specimens from patients with acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS). The devices must require interpretation by qualified pathologists or cytogeneticists and exclude automated systems with direct reporting.
Recommended Actions
- Prepare comprehensive probe documentation including specificity and sensitivity data
- Conduct required performance studies with appropriate patient samples
- Develop detailed control procedures and risk mitigation strategies
- Create compliant labeling with all required warnings and statements
- Compile clinical validity evidence through studies or literature
- Prepare detailed documentation of assay procedures and requirements
- Develop comprehensive training materials for qualified users
- Create clear result interpretation criteria and reporting guidelines
- Establish stability testing protocols for all required conditions
- Document all pre-analytical requirements and specifications
Key Considerations
Clinical testing
- Clinical validity must be demonstrated through clinical studies or minimum two peer-reviewed publications using the specific device
- Documentation must include:
- Proof that sponsor’s probe was used
- Number and type of specimens
- Target population studied
- Upper reference limit
- Range of positive probe results
Non-clinical testing
- Device analytical sensitivity data required
- Device analytical specificity data required
- Device reference limit data required
- Device precision/reproducibility data required
- Device stability data required including:
- Real-time stability
- Freeze-thaw stability
- Transport and temperature stability
- Post-hybridization signal stability
- Photostability of probe
Human Factors
- Results must be interpreted only by qualified pathologist or cytogeneticist
- Specific instructions and clinical training requirements must be included
Labelling
- Must include performance data summary and supporting studies
- Required warnings:
- Interpretation only by qualified pathologist/cytogeneticist
- Not for high-risk uses like therapy selection
- Not established for diagnosis, monitoring or risk assessment
- Statement about cited literature if used
Safety
- Control elements and risk mitigation procedures must be specified
- Must include safeguards against false positive and false negative results
Other considerations
- Detailed probe information required:
- Description of all probes
- Purpose of each probe
- Molecular specificity
- Probe specificity
- Probe limits
- Probe sensitivity
- Reagents and equipment specifications required
- Pre-analytical requirements must be specified
- Detailed assay procedure required
Relevant Guidances
- The Abbreviated 510k Program: Using Guidance Documents, Special Controls, and Standards for Substantial Equivalence Demonstration
- Refuse to Accept Policy for 510k Submissions: Minimum Threshold Requirements for Administrative and Technical Review
- Content and Decision-Making Process for 510k Submissions: Determining Substantial Equivalence
- User Fees and Refunds for 510k Submissions
Original guidance
- Early Growth Response 1 (EGR1) Gene Fluorescence In-Situ Hybridization Test Systems for Bone Marrow Specimens
- HTML / PDF
- Issue date: 2015-06-17
- Last changed date: 2019-04-11
- Status: FINAL
- Official FDA topics: Medical Devices, Laboratory Tests, 510(k), Labeling, Premarket, IVDs (In Vitro Diagnostic Devices), Immunology & Microbiology, Molecular and Clinical Genetics
- ReguVirta summary file ID: 62e34cf0eef68edfe3d6dbed51f59ac0
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