What is 510(k) Testing?
510(k) testing is a broad term that describes the analytical investigations necessary to demonstrate a new medical device is equivalent to another medical device currently on the market. These investigations must show that the new device is as safe and efficacious as the predicate device. Typically, this means the new device must be made from the same materials and have a similar design to the predicate device. If the new device is significantly different or utilizes new materials, then the manufacturer may need to submit a Premarket Approval (PMA) and may need to conduct more in-depth regulatory testing. Additional information regarding 510(k) requirements can be found on the FDA website.
510(k) Testing at EKG Labs
At EKG Labs we provide a variety of analytical solutions to support your 510(k) filing by helping to determine product equivalency. We have experience working with Class II and Class III medical devices as well as combination products that incorporate a pharmaceutical component.
EKG Labs works with clients to develop a customized 510(k) testing regimen specific to their medical device and submission goals. Our analysts are well-versed in a variety of USP and ISO compendial tests and analytical techniques. When you are ready to prepare your 510(k) filing, our regulatory services team can help you compose, submit, and communicate with regulatory agencies such as the FDA.
510(k) Analytical Testing Services
- Chemical Characterization
- Material Compatibility
- Biocompatibility (ISO 10993)
- Extractables and Leachables
- Impurity Identification
- Method Development
- Method Validation
- Failure Analysis
- Compendial Testing
EKG has extensive experience with a variety of medical device materials including:
- Polymers — Plastic, Rubber, Elastomer, Coatings, Adhesives, etc.
- Metals — Alloys, Electroplated Material, Titanium, Stainless Steel, etc.
- Ceramics — Alumina, Aluminum Oxide, Zirconia Compounds, etc.
- Specialty and Composite Materials
- Chromatography — HPLC, UPLC, LC/MS, GC/MS, GC/FID, GC/TCD, GPC/SEC
- Spectroscopy — ICP-MS, NMR, MS, PXRD, TF-XRD, UV-Vis, FTIR, Raman
- Microscopy — SEM, TEM, AFM, STM, LSCM
- Other — TGA, DSC, TOC, BET Surface Area/Pore Size Analyzer
- Learn more about our instrumentation here