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Liquichek Cardiac Markers Control is intended for use as an assayed quality control serum to monitor the precision of an individual laboratory's specific cardiac marker procedures.

Liquichek Cardiac Markers Control is prepared from human serum with added constituents of human and non-human origin. The control is provided in liquid form for convenience.

This document is a 510(k) summary for a medical device called "Liquichek Cardiac Markers Control." It is a quality control material used to monitor the precision of laboratory cardiac marker procedures. The document aims to demonstrate substantial equivalence to a previously cleared device, the "Liquichek CK/LD Isoenzyme Control."

Based on the provided text, there is no information available regarding acceptance criteria, device performance metrics, or a study demonstrating that the device meets specific acceptance criteria. This document describes a quality control material, not a diagnostic or therapeutic device whose performance is typically evaluated against clinical endpoints or diagnostic accuracy metrics.

Therefore, I cannot provide the requested information. The document focuses on:

• Device Identification and Classification: Naming the device, its classification, and intended use.
• Substantial Equivalence Claim: Comparing its technological characteristics (intended use, form, matrix, storage, open vial claim) to a predicate device.
• Composition: Stating it's prepared from human serum with human and non-human constituents.

The concept of "acceptance criteria" and "device performance" as typically applied to diagnostic algorithms or medical devices that generate results (e.g., sensitivity, specificity, accuracy) is not directly applicable or discussed in this 510(k) summary for a quality control material.

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