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The Randox Laboratories Ltd. Urine Controls are based on lyophilised human urine and have been developed for the control of both accuracy and precision in clinical chemistry applications particularly urine analysis. These control materials are available at two constituent concentrations.

The Randox Assayed and Unassayed Urine Controls should only be used by suitably qualified laboratory personnel under appropriate laboratory conditions.

Assayed and Unassayed Urine Controls based on lyophilised human urine.

This document is a 510(k) clearance letter from the FDA for "Randox Urine Controls," which are classified as a Class I quality control material. It confirms that the device is substantially equivalent to a legally marketed predicate device.

Based on the provided text, the document does not contain information related to acceptance criteria, specific device performance data, study designs (sample sizes, provenance, ground truth, expert qualifications, adjudication methods), multi-reader multi-case studies, or standalone algorithm performance. This is typical for a 510(k) clearance letter for a Class I device like a quality control material, which generally relies on demonstrating substantial equivalence to a predicate rather than extensive clinical efficacy studies.

Therefore, I cannot provide the requested table and details because the information is not present in the document.

The document focuses on:

• Device Name: Randox Urine Controls (Assayed and Unassayed)
• Regulation Number/Name: 21 CFR 862.1660, Quality control material (assayed and unassayed)
• Regulatory Class: Class I
• Product Code: JJW
• Indication for Use: For the control of both accuracy and precision in clinical chemistry applications, particularly urine analysis. Available at two constituent concentrations and to be used by suitably qualified laboratory personnel.

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