(137 days)
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.
§ 866.3820
Treponema pallidum nontreponemal test reagents.(a)
Identification. Treponema pallidum nontreponemal test reagents are devices that consist of antigens derived from nontreponemal sources (sources not directly associated with treponemal organisms) and control sera (standardized sera with which test results are compared) used in serological tests to identify reagin, an antibody-like agent, which is produced from the reaction of treponema microorganisms with body tissues. The identification aids in the diagnosis of syphilis caused by microorganisms belonging to the genusTreponema and provides epidemiological information on syphilis.(b)
Classification. Class II (performance standards).