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ABC Linearity Verifiers is intended to be used to verify the calibration, linear operating range and reportable range (linearity) of methods used to determine the concentration of selected therapeutic drugs.
ABC Linearity Verifiers should be used any time it is necessary to confirm the proper calibration ind linear operating range of TDM methods and instruments. The Clinical Laboratory Improvenent Act and its regulations (CLIA) require verification of timearity and calibration twice a year for modified moderately complex methods, highly complex methods and in-house methods. Verification should be performed more often if any of the following occurs: introduction of procedures for which control values change with a new reagent lot, major preventative maintenance or replacement of critical parts on the instrument, when control values exhibit an unusual trend or shift or are outside the acceptable limits of the laboratory, and if the laboratory's schedule of verification is more frequent.

ABC Linearity Verifiers is an in vitro diagnostic medical device intended for use with automated and manual methods monitoring selected therapeutic drugs (TDM). ABC Linearity Verifiers is a five level set of verifiers, with each level containing 12 analytes, is made with human serum and is used to confirm the proper callbration, linear operating range and reportable range (linearity) of TDM methods. The "ABC" designation derives from Antibiotic and Cardiac drugs. ABC Linearity Verifiers contains concentrations of analytes extending over a wide analytical range. Level 1 is a zero level, and level 5 has concentrations near the upper limit of instruments. Levels 1, 2, 3, and 4 are related by linear dilution. When assayed like patient samples, the verifiers assist in determination of calibration and linear operating range (linearity) of methods for the analytes included.

I am sorry, but based on the provided text, there is no information about acceptance criteria or a study proving that "ABC Linearity Verifiers" meet specific acceptance criteria.

The document is a 510(k) summary for a medical device registration. It describes the device, its intended use, and compares its technical characteristics to predicate devices. It states that "The performance of ABC Verifiers has been tested on two commonly used automated therapeutic drug monitoring systems (Abbott TDx Assay System and Behring (formerly Syva) EMIT system reagents) and by HPLC methods for selected analytes to validate their use. All methods tested demonstrated the desired functionality of the product." However, it does not provide:

• A table of acceptance criteria and reported device performance.
• Details about sample sizes, data provenance, number or qualifications of experts, or adjudication methods for any test set.
• Information on a multi-reader multi-case (MRMC) comparative effectiveness study or standalone performance.
• The type of ground truth used, or details about the training set for any algorithm.

The document primarily focuses on establishing substantial equivalence to existing predicate devices based on technical characteristics and intended use, rather than presenting detailed performance study results against predefined acceptance criteria.

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