We will identify areas in need of attention. These will commonly include reports for correction and removal, label optimization, resource management, product realization, and measurement, analysis and improvement. You will understand potential areas that need further work and documentation.
Using your BOM and production information, our experts will quickly assess the manufacturability of your product to determine adherence to design for manufacturing (DfM) principles. This is a good first step to identify projected gaps in manufacturability and the corresponding effort, time, and resources required to bridge the gaps.
Prior to transferring your product to cGMP, Argonaut will perform an engineering run to test the manufacturing process, identify and resolve potential issues, assess equipment and procedures, then send the product to you for functionality testing. We can also assess efficiency of material usage and propose modifications that will reduce materials costs.
Get support for select analytical studies including interference, inhibition, cross-reactivity, preparation of negative matrix, standardization of controls, and more.
This package comprises of a detailed process characterization, establishment of critical process parameters, stability studies, controls manufacturing, and risk and hazard analsysis (pFEMA).
You will receive a fully documented package of processes and controls used to manufacture your product that is used in a 510(k) or PMA submission. Manufactured product will adhere to cGMP and ISO quality standards
| FDA Stage | Effective how long after final rule is published | Labs making LDT’s required to comply with these FDA requirements | Argonaut Services ----------------------------------------------- Lab Activities |
|---|---|---|---|
| 1 | 1 year | Medical Device Reporting (MDR): Correction and Removal Reporting | Gap assessment- CLIA QMS to QSR Manufacturing Assessment ------------------------------------------------- Implement MDR, manual Correction & Removal Reporting System |
| 2 | 2 years | Registration and listing, labeling; investigational use | Engineering Run Process Validation ------------------------------------------------- FDA Site Registration Correct labels on reagents, protocols, marketing materials, etc. |
| 3 | 3 years | QSR 21 CFR Part 820 | cGMP & ISO Manufacturing Analytical Support ------------------------------------------------- QSR Implementation & Documentation |
| 4 | 3.5 years but not before October 1, 2027 | Pre-market review – 510(k) and PMA High-Risk LDT | PMR Documentation Analytical Support ------------------------------------------------- Clinical Trials/Submission |
| 5 | 4 years but not before April 1, 2028 | Pre-market review – 510(k) and PMA Moderate & Low-Risk LDT | PMR Documentation Analytical Support ------------------------------------------------- Clinical Trials/Submission |
The best way to start is first understanding what needs to be done. Assessing your documentation and the manufacturability of your product is key and will point out both strengths and gaps. Our finished assessments will allow your team to address costs and resources for the LDT to 510(k) journey, while also providing you support to address the Year 1 QSR requirement of implementing a Correction and Removal System (if your team does not have one yet).
With the assessments finished, we will help your team address the Year 2 QSR requirements for labeling. We can provide controlled physical labels, help you develop your labeling protocols, and provide the documentation system. Registering your facility with the FDA is relatively straight-forward but we can also assist here if needed.
By Year 3, we can have your assay and manufacturing protocols within our eQMS, meeting that portion of QSR requirements. Your assay reagents will be manufactured under cGMP. We can also work with you on the Design Files and house this within our eQMS.
By the end of Year 3 your assay will be manufactured ready for analytical and clinical studies. Our team can help the lifting for the analytical studies.
Our story is one of partnership and innovation. At Argonaut, we understand that life science and diagnostic companies demand excellence in every aspect of product development and RUO & IVD manufacturing.
With unparalleled scalability and flexibility we deliver quality with greater speed to market and reduced risk, while minimizing capital expenditure. Importantly, we are not a product company. We only perform manufacturing services, so we will never compete against your products.
Our team has taken numerous devices through regulated environments and we were founded on manufacturing IVD’s. Our teams have manufactured qPCR/PCR assays, NGS kits, lateral flow assays, HPLC reagents and more. Additionally, we have worked with regulatory agencies, so we know what they find acceptable and stand ready to support you during audits.
While many contract manufacturers can show pretty pictures of their facility, we stand out. They might have a clean-room. Argonaut has over 22 labs under ISO 8 containment. They ship to you. We warehouse, pick, pack and ship on demand. Our scale works for you during this critical mandated timeline.
Prioritizing quality from day one, the Argonaut Quality Management System is the overarching structure that houses all other systems, including ERP. Argonaut’s Quality Management System is compliant to ISO 13485:2016, cGMP, and quality system regulations 21 CFR 820, 21 CFR 210, 21 CFR 211, and Argonaut is FDA registered, FDA audited (CDRH), and CA FDB audited (link to certificates).
The regulatory environment is dynamic, so here are some FAQ’s that you may need to consider during your LDT to 510(k) journey.