Most repeat testing can be traced to a study that did not answer the complete regulatory question, whether through the wrong specimen matrix, too few lots or acceptance criteria set after data collection.
Laboratory services
Abingdon Analytical’s performance evaluation study plans are structured with your intended certification as the reference point, inclusive of FDA and IVDR. Studies are run in our dedicated, independent Doncaster laboratory, by a multi-disciplinary team trained in line with CLSI, ICH and ISO standards and guidelines.
What we test
Analytical performance demonstrates the ability of your device to correctly detect or measure a particular analyte. We run these studies for molecular, immunoassay and point-of-care platforms as well as lateral flow, with sample sizes, lots and acceptance criteria agreed before testing starts, to ensure evidence gathered meets regulatory compliance requirements.
A clinical performance evaluation assesses the safety and performance of the device when used as intended by the manufacturer. We design and manage these studies in the target population, with analytical and clinical data held in one traceable record.
Studies we run
| Study type | What this shows a reviewer | Reference guidance |
|---|---|---|
| Analytical Sensitivity (LOD) | The lowest analyte level your test detects reliably | CLSI EP17 |
| Analytical Specificity (Interference & Cross-Reactivity) | Related organisms and common interferents do not cause false results | CLSI EP07, EP37 |
| Precision (Repeatability & Reproducibility) | Consistent results across runs, days, operators, lots and sites | CLSI EP05, EP12, EP15 |
| Matrix Equivalence | Performance holds across every claimed specimen type | CLSI EP35 |
| Measuring Range (Hook Effect) | Results stay accurate across the range, including very high concentrations | CLSI EP06 |
| Flex & Robustness | Performance holds under realistic user and environmental variation | FDA CLIA waiver guidance |
| Stability (Shelf Life, Shipping & In Use) | Labelled claims are supported by real-time and stress data | CLSI EP25, ISO 23640 |
Beyond performance evaluation
Validation and verification (V&V) evidence depends on the study methods behind it. We develop analytical and clinical performance evaluation methods in line with CLSI, ICH and ISO guidance, with defined sample sizes and pre-set acceptance criteria, then use them to validate and verify your device against its intended claims.
Late release testing delays revenue. The Abingdon Analytical team tests finished lots against your approved specifications and issues a documented certificate of analysis within agreed turnaround times, giving your Quality Assurance team an independent release record for every batch.
We provide incoming material, in-process and finished-product QC testing, including critical reagents such as antibodies, antigens and calibrators. Results are trended across lots so drift is flagged before it becomes a non-conformity, a failed release, or a field issue.
Tests for lay users or non-laboratory professionals must show the intended user can perform and read them correctly. We design and run usability studies referenced to IEC 62366-1 and FDA human factors guidance, alongside the necessary performance evaluation studies required for your products and desired regulatory pathways.
Our capabilities include formative and summative usability studies, use-related risk analysis, critical task assessments, label comprehension studies, healthcare professional and lay-user evaluations, home-use assessments, workflow and user interface reviews, and human factors validation to support regulatory submissions.
From the Knowledge Centre
Practical guidance from the specialists who deliver this work every day.
Article
Why ISO/IEC 17025 Accreditation Matters to Your Regulatory Submission
Learn how ISO/IEC 17025 accreditation supports reliable testing, method validation and regulatory confidence for medical devices and diagnostics.
Also worth reading
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Abingdon Analytical Performance Evaluation Brochure
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Performance Evaluation for FDA 510(k): Building Your Substantial Equivalence Case
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Analytical Performance and Clinical Evaluation: synchronised for success
Frequently asked questions
ISO/IEC 17025 is the international standard for testing and calibration laboratories, demonstrating technical competence and the ability to produce reliable results. Working with an ISO/IEC 17025 accredited laboratory provides confidence that analytical testing has been performed using validated methods and recognised quality processes.
Laboratory testing generates the analytical evidence needed to support FDA submissions, EU MDR compliance and IVDR requirements. Testing data can be used within technical documentation, performance evaluation activities and product validation programmes to demonstrate safety and performance.
Yes. We support assay development, assay optimisation and assay validation activities for diagnostic developers seeking to improve performance, generate evidence and prepare for regulatory review. The resulting data can support product development, performance evaluation and future market access activities.
The analytical performance studies required for an IVD depend on the product’s intended use, technology and regulatory pathway. Performance studies help manufacturers generate evidence to support performance evaluation, technical documentation and regulatory submissions.
Laboratory services generate the evidence used to support technical documentation, performance evaluation and regulatory decision-making. Robust analytical data can strengthen submissions and help manufacturers progress towards commercialisation in regulated markets.
Start the conversation
Tell us about your device, its intended purpose and the markets you are targeting, and we will map the studies your submission needs.