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Ampcor RPR control kit is designed as an unassayed control material to monitor the precision of AMPCOR RPR (Carbon-Particle) Liquid Reagent or other RPR tests at three reaction levels.

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The provided text is a 510(k) clearance letter from the FDA for a device called "ADI Syphilis RPR Liquid Controls." This letter grants clearance based on substantial equivalence to a predicate device, which is different from a study proving a device meets acceptance criteria.

The document does not contain any information about:

• Acceptance criteria table or reported device performance for a study.
• Sample sizes for test or training sets, data provenance, or ground truth establishment.
• Number or qualifications of experts.
• Adjudication methods.
• Multi-reader multi-case (MRMC) comparative effectiveness studies or standalone algorithm performance.

The document's purpose is to inform Ampcor Diagnostics, Inc. that their device is substantially equivalent to a previously marketed device and can therefore be marketed. It refers to general controls provisions of the Act and compliance with Good Manufacturing Practice requirements, but it does not detail a specific performance study or its results for the ADI Syphilis RPR Liquid Controls device itself.

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