(245 days)
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I apologize, but the provided text segments are either in a non-English language (Khmer, Arabic, Hindi, Japanese as identified by optical character recognition) or contain a lot of noise and fragmented characters that prevent me from understanding the content.
Therefore, I cannot extract any information related to acceptance criteria, device performance, study details, expert qualifications, or ground truth establishment to answer your request.
If you can provide the input in a clear, English-readable format, I would be happy to assist you in describing the acceptance criteria and study details.
§ 864.4010 General purpose reagent.
(a) A general purpose reagent is a chemical reagent that has general laboratory application, that is used to collect, prepare, and examine specimens from the human body for diagnostic purposes, and that is not labeled or otherwise intended for a specific diagnostic application. It may be either an individual substance, or multiple substances reformulated, which, when combined with or used in conjunction with an appropriate analyte specific reagent (ASR) and other general purpose reagents, is part of a diagnostic test procedure or system constituting a finished in vitro diagnostic (IVD) test. General purpose reagents are appropriate for combining with one or more than one ASR in producing such systems and include labware or disposable constituents of tests; but they do not include laboratory machinery, automated or powered systems. General purpose reagents include cytological preservatives, decalcifying reagents, fixative and adhesives, tissue processing reagents, isotonic solutions and pH buffers. Reagents used in tests for more than one individual chemical substance or ligand are general purpose reagents (e.g.,
Thermus aquaticus (TAQ) polymerase, substrates for enzyme immunoassay (EIA)).(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9. If the device is not labeled or otherwise represented as sterile, it is exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of § 820.180, with respect to general requirements concerning records, and § 820.198, with respect to complaint files.