(20 days)
Liquichek Urinalysis Control is intended for use as an assayed quality control urine to monitor the precision of laboratory dipstick and microscopic testing procedures for the analytes listed in the package insert.
Liquichek Urinalysis Control is prepared from human urine with added human erythrocytes, leukocytes and constituents of non-human origin and pure chemicals. The control is provided in liquid form for convenience.
Level 2 of this product contains 0.1% sodium azide as a preservative.
This document is a 510(k) summary for the Bio-Rad Liquichek Urinalysis Control, a quality control product for laboratory dipstick and microscopic testing. It describes the device, its intended use, and compares its technological characteristics to a substantially equivalent device.
Based on the provided information, the document does not describe acceptance criteria, a study proving the device meets acceptance criteria, or any of the specific details requested in your prompt related to the performance of an AI/ML device.
This a regulatory submission for a laboratory control solution, not an AI or machine learning device. Therefore, the requested information elements (such as sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, etc.) are not applicable to the content of these documents.
If you have a document describing an AI/ML device and its validation studies, I would be happy to analyze it against your criteria.
§ 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.