FDA IVD Testing & Validation Services
End-to-End Support for FDA Diagnostic Assay Submissions
We provide comprehensive analytical and clinical testing services to support FDA diagnostic (IVD) submissions, including 510(k), De Novo, PMA, EUA, and CLIA Waiver pathways. Our studies are designed to meet FDA and CLSI expectations and generate submission-ready data you can rely on.
FDA IVD Testing & Validation Service
End-to-End Support for FDA Diagnostic Assay Submissions
We provide comprehensive analytical and clinical testing services to support FDA diagnostic (IVD) submissions, including 510(k), De Novo, PMA, EUA, and CLIA Waiver pathways. Our studies are designed to meet FDA and CLSI expectations and generate submission-ready data you can rely on.
Our Expertise
Leveraging the power of genomics, cell biology, microbiology, immunoassays, and other advanced technologies, Avance Biosciences has extensive experience supporting clients with testing and validation of diagnostic assays and companion diagnostics for their IVD submissions. Our comprehensive approach ensures precise, reliable, and clinically relevant results, facilitating the generation of FDA-ready data packages, clear traceability from requirements to results, and a more efficient regulatory review process.
End-to-End Support for FDA Diagnostic Assay Submissions
Assay Types We Support
Assay Type
Benchtop Testing
Analytical Performance
Clinical Performance
Point of Care (POC)
Molecular
(PCR/NGS)
Immunoassays
(ELISA/LFA)
Clinical Chemistry
(LC-MS/MS)
Regulatory Pathways We Support
FDA Submission Pathway
Description
Testing Required
510(k) Premarket Notification
For assays with a predicate device
We design and execute analytical and clinical performance studies to demonstrate substantial equivalence to a legally marketed predicate.
- Predicate comparison strategies
- Full analytical performance testing
- Clinical performance studies (when required)
- Submission-ready reports
De Novo Classification
For novel assays with no predicate
We support first-of-a-kind diagnostics by generating the data needed to establish a new Class I or II device classification.
- Risk-based study design
- Analytical and clinical validation
- Data supporting special controls
- Future 510(k) predicate positioning
Premarket Approval (PMA)
For high-risk diagnostic assays
Our PMA-grade testing programs generate the independent evidence required to demonstrate safety and effectiveness.
- Comprehensive analytical validation
- Clinical performance studies
- IDE support (as applicable)
- PMA-level documentation and traceability
Emergency Use Authorization (EUA)
For declared public health emergencies
We deliver accelerated analytical and clinical studies aligned with FDA emergency expectations.
- LoD and analytical sensitivity
- Inclusivity and cross-reactivity
- Rapid protocol development
- Emergency-aligned reporting
CLIA Waiver by Application
For point-of-care and home-use tests
We design studies demonstrating that your assay is simple to use and has a low risk of erroneous results.
- Flex studies
- Dual CLIA + 510(k)/De Novo support
Our IVD Testing Services
Service
Description
Testing Required
Analytical Performance
- Limit of Detection (LoD) and Limit of Quantitation (LoQ)
- Accuracy and method comparison
- Precision (repeatability, intermediate precision, reproducibility)
- Linearity and measuring range
- Analytical specificity (cross-reactivity, interference, carryover)
Benchtop Testing
Sample & Matrix Studies
- Matrix equivalency (serum, plasma, whole blood)
- Sample type validation
- Stability (real-time, freeze–thaw, transport conditions)
Reagent & System Robustness
- Real-time and accelerated stability
- Open-vial and on-instrument stability
- Environmental stress testing
- Operator variability simulations
Analytical Performance Protocols
FDA-ready protocols designed to withstand regulatory review.
- Study design and statistical analysis plans
- CLSI and FDA guidance alignment
- Predicate and reference method strategy
- Pre-submission protocol support
- Deviation management and justification
Clinical Performance Studies
Clinical evidence demonstrating how your assay performs in real-world patient populations.
- Clinical sensitivity and specificity
- Comparator method alignment
- Patient sample testing
- Multi-site study coordination
- IDE support when required
Quality Assurance
- Rigorous quality control processes (GLP/CLIA) to ensure the highest standards of data integrity and reproducibility for your IVD submission.
- Adherence to FDA, CLSI, and international regulatory expectations for IVD development and validation.
- Regulatory compliance and certifications: 21 CFR–compliant operations, FDA registered and inspected facilities, and CLIA-registered testing services.