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Retrieve results and track sample progress in real time with access to featured digital products such as CoreViewer™ and ALS QCPro™.
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This convenient application lets customers closely track oil analysis reports in process in real time.
LoginALS provides IRB-approved skin prick testing to assess immediate (IgE-mediated) hypersensitivity for topically-applied devices. ALS designs SPT studies to complement the biocompatibility evidence required in 510(k) submissions with human data that supports risk-based evaluations under ISO 10993 planning.
Yes. FDA expects biocompatibility evidence in 510(k) submissions for devices with patient contact, typically following ISO 10993-1.
SPT does not replace ISO 10993 testing but can strengthen a risk-based submission by complementing delayed sensitization and irritation testing (ISO 10993-10 and 10993-23), particularly when immediate (IgE-mediated) hypersensitivity is a concern.
ALS will scope your project and provide a detailed quote with timelines and deliverables.
Get a quoteProcess for clinical testing for anti-aging and skin renewal claims
Quotes depend on:
ALS provides a detailed quote with transparent assumptions and options for expedited start-up.
No. It is run when risk indicates immediate (IgE) allergy.
No. SPT supports the overall biocompatibility strategy for 510(k) submissions. ISO 10993-10 and 10993-23 remain the standard methods for sensitization and irritation, and SPT adds immediate hypersensitivity data where relevant.
The number depends on the study objectives, the device’s risk classification, and the type of data needed to support your submission. ALS can advise on typical ranges during the scoping process.
Readouts occur at the visit. Reports are typically available 4 weeks after conduct.
Yes. ALS prepares, submits, and manages the package; you receive approvals.
Yes—where relevant, reports align with FDA-preferred language (e.g., latex).
Compliance Note
SPT is supportive evidence within a risk-based biocompatibility plan. ALS does not imply FDA endorsement or guarantee clearance. This page does not provide medical advice. Study design, endpoints, and reporting follow ISO 10993, IRB/ethics requirements, and regulatory expectations.
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