(27 days)
UrichemTRAK Liguid Assayed Control is a human urine based quality control material used in various general chemistry assays. The product is intended for use as a consistent test sample of known concentrations that is assayed along with patient urine specimens when performing urine chemistry assays. The Clinician can compare recovered values over an extended period of time as a means of evaluating analytical precision, as well as reagent and instrument performance.
UrichemTRAK Liquid Assayed Control, Levels 1 and 2
I am sorry, but the provided text is a 510(k) clearance letter from the FDA for a medical device called "Urichem TRAK Liquid Assayed Control, Levels 1 and 2." This document primarily focuses on regulatory approval, intended use, and general controls.
It does not contain the detailed information required to answer your request about acceptance criteria and the specifics of a study proving the device meets those criteria. Specifically, the document does not provide:
- A table of acceptance criteria and reported device performance.
- Sample size used for the test set and data provenance.
- Number of experts used to establish ground truth and their qualifications.
- Adjudication method.
- Information about a multi-reader multi-case (MRMC) comparative effectiveness study.
- Details on standalone (algorithm only) performance.
- The type of ground truth used (expert consensus, pathology, etc.).
- The sample size for the training set.
- How the ground truth for the training set was established.
The document states the device's "Statement of Indications for Use" as a quality control material for general chemistry assays, intended for evaluating analytical precision, reagent, and instrument performance. This type of device is a control material, not typically an AI-powered diagnostic or decision support system that would undergo the kind of detailed performance studies you're asking about in the context of AI.
Therefore, I cannot fulfill your request based on the provided input.
§ 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.