(183 days)
The Randox Liquid Urine Controls Level 2 and Level 3 are liquid controls containing Amylase, Calcium, Chloride, Cortisol, Creatinine, Glucose, hCG pregnancy, Magnesium, Microalbumin, Osmolality, pH, Inorganic Phosphate, Potassium, Total Protein, Sodium, Specific Gravity, Urea and Uric Acid. They have been developed for in vitro diagnostic use in the quality control of Amylase, Calcium, Chloride, Cortisol, Creatinine, Glucose, hCG pregnancy, Magnesium, Microalbumin, Osmolality, pH, Inorganic Phosphate, Potassium, Total Protein, Sodium, Specific Gravity, Urea and Uric Acid assays on various clinical chemistry systems. This in vitro diagnostic device is intended for prescription use only.
The Randox Liquid Urine Controls Level 2 and Level 3 are liquid controls containing Amylase, Calcium, Chloride, Cortisol, Creatinine, Glucose, hCG pregnancy, Magnesium, Microalbumin, Osmolality, pH, Inorganic Phosphate, Potassium, Total Protein, Sodium, Specific Gravity, Urea and Uric Acid.
This is a 510(k) premarket notification for a medical device called "Randox Liquid Urine Controls, Level 2 and Level 3". The document is a clearance letter from the FDA, not a study report. Therefore, it does not contain the detailed information about acceptance criteria or a study that proves the device meets those criteria with the level of detail requested.
The document states that the FDA reviewed the 510(k) and determined the device is "substantially equivalent" to legally marketed predicate devices. This determination is based on the information provided by the manufacturer in the 510(k) submission, which would have included performance data, but that data is not present in this FDA clearance letter.
Therefore, I cannot provide the requested information. The document does not describe:
- A table of acceptance criteria and the reported device performance: This information would be in the manufacturer's performance study report, not the FDA clearance letter.
- Sample size used for the test set and the data provenance: Not present.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not present.
- Adjudication method for the test set: Not present.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and its effect size: Not applicable for a quality control material.
- If a standalone study was done: Not present.
- The type of ground truth used: Not present.
- The sample size for the training set: Not applicable for a quality control material.
- How the ground truth for the training set was established: Not applicable for a quality control material.
The document indicates the device's intended use is for in vitro diagnostic quality control of various analytes on clinical chemistry systems. The FDA clearance means they believe the device performs similarly to existing legally marketed devices for this purpose, based on the submitted data. However, the details of that supporting data are not in this provided text.
§ 862.1660 Quality control material (assayed and unassayed).
(a)
Identification. A quality control material (assayed and unassayed) for clinical chemistry is a device intended for medical purposes for use in a test system to estimate test precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation. A quality control material (assayed and unassayed) may be used for proficiency testing in interlaboratory surveys. This generic type of device includes controls (assayed and unassayed) for blood gases, electrolytes, enzymes, multianalytes (all kinds), single (specified) analytes, or urinalysis controls.(b)
Classification. Class I (general controls). Except when intended for use in donor screening tests, quality control materials (assayed and unassayed) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.