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The Randox Urinalysis Controls (URNAL Control 1 and URNAL Control 2) are urine controls containing Bilirubin, Blood, Creatinine, Crystals, Galactose, Glucose, hCG, Ketones, Leukocytes, Microalbumin, Nitrite, pH, Protein, Red Blood Cells, Specific Gravity, Urobilinogen and White Blood Cells. The Randox Urinalysis controls (URNAL Control 1 and URNAL Control 2) are intended for in vitro diagnostic use in the quality control of urine test strips for the analytes; Bilirubin, Blood, Creatinine, Glucose, Ketones, Leukocytes, Microalbumin, Nitrite, pH. Protein, Specific Gravity and Urobilinogen. This control is also intended for the evaluation of microscopic test procedures for Crystals, Red Blood Cells and White Blood Cells and also for the confirmatory tests hCG and Galactose. This in vitro diagnostic device is intended for prescription use only

The Randox Urinalysis Controls (URNAL Control 1 and URNAL Control 2) are urine controls containing Bilirubin, Blood, Creatinine, Crystals, Galactose, Glucose, hCG, Ketones, Leukocytes, Microalbumin, Nitrite, pH, Protein, Red Blood Cells, Specific Gravity, Urobilinogen and White Blood Cells.

This document is a 510(k) clearance letter from the FDA for a medical device called "Randox Urinalysis Controls URNAL Control 1 and URNAL Control 2." This type of document is an approval for marketing based on substantial equivalence to a predicate device, not a detailed study report. Therefore, it does not contain the specific information requested in your prompt regarding acceptance criteria and detailed study data.

The letter explicitly states: "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices..."

Here's why the requested information cannot be extracted from this document:

• Acceptance Criteria and Device Performance: The letter confirms substantial equivalence, meaning the new device performs similarly to an existing, legally marketed device. It does not provide specific acceptance criteria or an analytical study comparing the performance of the new device against those criteria.
• Sample Size and Data Provenance: This information would be found in the detailed study report submitted as part of the 510(k) application, which is not provided here.
• Experts and Adjudication Method: These details are relevant for studies establishing ground truth, which are typically part of the scientific evidence supporting the 510(k) application, not the clearance letter itself.
• MRMC Comparative Effectiveness Study: This letter does not describe any MRMC studies or human-in-the-loop performance.
• Standalone Performance: The letter does not detail standalone algorithm performance.
• Type of Ground Truth: The letter doesn't specify how ground truth was established for any studies, as it's not a study report.
• Training Set Sample Size and Ground Truth Establishment (Training Set): These are details of the development and validation of the device, which would be in the technical documentation of the 510(k) submission, not the FDA's clearance letter.

In summary, this document is an FDA clearance letter for a device based on substantial equivalence, not a scientific study report. Therefore, it does not contain the detailed study results and acceptance criteria information you are seeking.

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