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The Randox Laboratories Ltd. Tri-Level Cardiac Control (Level I, II and III) are based on lyophilized human serum and have been developed for the control of both accuracy and precision in clinical chemistry applications, specifically cardiac monitoring. The control materials are available at three constituent concentrations. Each level is available in a 1 ml final re-constituted volume.

The Randox Tri-Level Cardiac Controls should only be used by suitably qualified laboratory personnel under appropriate laboratory conditions.

The Randox Laboratories Ltd. Tri-Level Cardiac Control (Level I, II and III) are based on lyophilized human serum and have been developed for the control of both accuracy and precision in clinical chemistry applications, specifically cardiac monitoring. The control materials are available at three constituent concentrations. Each level is available in a 1 ml final re-constituted volume.

This document is a 510(k) premarket notification letter from the FDA to Randox Laboratories Ltd. for their "Tri-Level Cardiac Control" device. It confirms that the device is substantially equivalent to a legally marketed predicate device.

The provided text does not contain information about acceptance criteria or a study proving the device meets acceptance criteria as typically expected for a medical device's performance evaluation (e.g., sensitivity, specificity, accuracy, clinical trial results). This document is a regulatory approval letter, not a device performance study report.

Therefore, I cannot fulfill the request for a table of acceptance criteria, device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone studies, ground truth types, or training set details based on the provided text.

The information present in the document is:

• Device Name: Tri-Level Cardiac Control
• Manufacturer: Randox Laboratories Ltd.
• Regulation Number: 21 CFR 862.1660
• Regulation Name: Quality control material (assayed and unassayed)
• Regulatory Class: Class I
• Product Code: JJY
• Indications For Use: "The Randox Laboratories Ltd. Tri-Level Cardiac Control (Level I, II and III) are based on lyophilized human serum and have been developed for the control of both accuracy and precision in clinical chemistry applications, specifically cardiac monitoring. The control materials are available at three constituent concentrations. Each level is available in a 1 ml final re-constituted volume."

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