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The provided text is a "SUMMARY OF SAFETY AND EFFECTIVENESS" for the ACCUTREND® CHOLESTEROL TEST, dated March 6, 1996. This document is a pre-market notification (510(k)) summary, which focuses on demonstrating substantial equivalence to a predicate device.
Based on the information provided, it states that the Accutrend® Cholesterol Test is substantially equivalent to Chemtrak's AccuMeter Cholesterol Self Test for measuring total cholesterol in whole blood.
However, the provided text does not contain the detailed study information required to answer your specific questions about acceptance criteria, device performance, sample sizes, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies.
The document primarily focuses on establishing substantial equivalence by comparing the methodology and intended use of the Accutrend® Cholesterol Test with a predicate device (AccuMeter Cholesterol Self Test), rather than presenting a detailed clinical study report with acceptance criteria and performance metrics described in your request.
Therefore, I cannot populate the table or answer the specific questions based solely on the provided text.
To provide the requested information, a more detailed study report or clinical data summary for the Accutrend® Cholesterol Test would be necessary. This type of information is typically found in accompanying clinical trial reports or detailed performance data submissions, which are not present in this "SUMMARY OF SAFETY AND EFFECTIVENESS" document.
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SUMMARY OF SAFETY AND EFFECTIVENE
ACCUTREND® CHOLESTEROL TEST MAR - 6 1996
The Accutrend® Cholesterol Test is substantially equivalent to Chemtrak's AccuMeter Cholesterol Self Test. Both systems are used to measure total cholesterol in whole blood. The procedure for both tests entails applying a cappilary blood sample to a dry chemistry test strip or cartridge. Both test systems utilize non-wipe technologies. The cholesterol esterase reaction is measured in both tests. Both test systems have lot-specific coding for each lot of test strips or cartridges. Finally, both the Accutrend and AccuMeter systems are cholesterol screening devices which have been cleared specially for home use.
Boehringer Mannheim Corporation 9115 Hague Road Indianapolis, Indiana 46256
9
§ 862.1175 Cholesterol (total) test system.
(a)
Identification. A cholesterol (total) test system is a device intended to measure cholesterol in plasma and serum. Cholesterol measurements are used in the diagnosis and treatment of disorders involving excess cholesterol in the blood and lipid and lipoprotein metabolism disorders.(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 § 862.9.