ACCU-CHEK INSTANT PLUS CHOLOESTEROL TEST

• K Number: K944458
• Device Name: ACCU-CHEK INSTANT PLUS CHOLOESTEROL TEST
• Manufacturer: BOEHRINGER MANNHEIM CORP.
• Date Cleared: 1996-03-06 ( 541 days)
• Product Code: CHH
• Regulation Number: 862.1175
• Type: Traditional
• Panel: CH
• Reference & Predicate Devices: N/A
• Predicate For: K051376

Intended Use

Not Found

Device Description

Not Found

AI/ML Overview

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.

Regulation Number and Section

§ 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.