(32 days)
Urine Chemistry Control, Level 1, is a lyophilized human urine based assayed quality control material intended to monitor the performance of urine chemistry test procedures that analyze inorganics, metals, drugs, endocrine hormones and metabolites.
Urine Chemistry Control, Level 1, is designed to monitor the performance of urine chemistry test procedures that analyze inorganics, metals, drugs, endocrine hormones and metabolites. Human and porcine components are added to a human urine based matrix to provide a control that closely mimics human urine. The product contains no preservatives. Urine Chemistry Control, Level 1 will be offered in 10.0 mL and 25.0 mL fill vials.
1. Table of Acceptance Criteria and Reported Device Performance
This submission does not explicitly state "acceptance criteria" in the traditional sense of performance metrics for an AI/CADe device. Instead, it focuses on demonstrating "substantial equivalency" to a predicate device for a control material (Urine Chemistry Control, Level 1). The performance is evaluated by comparing its characteristics to those of the predicate device.
Acceptance Criteria (Implied for Substantial Equivalency): The implied acceptance criteria for substantial equivalency is that the technological characteristics of the new device are "as safe and effective as" the predicate device and do not raise new questions of safety or effectiveness. This is shown through direct comparison of features.
| Device Characteristic | Acceptance Criteria (Predicate) | Reported Device Performance (Urine Chemistry Control, Level 1) |
|---|---|---|
| Intended Use | Assayed quality control urine for monitoring precision of laboratory testing procedures. | Assayed quality control urine for monitoring performance of urine chemistry test procedures. |
| Matrix | Human Urine | Human Urine |
| Form | Lyophilized | Lyophilized |
| Analytes | 51 analytes | 48 analytes of clinical significance that may be found in urine. |
| Storage | 2-8°C | 2-8°C |
| Stability | Until expiration date noted on vial label | Until expiration date noted on vial label |
2. Sample Size Used for the Test Set and Data Provenance
This document does not describe a "test set" in the context of evaluating an AI/CADe device. The submission is for a control material. The evaluation relies on a comparative analysis of product characteristics rather than performance data derived from a distinct test set. Therefore, information on sample size and data provenance for a test set is not applicable or provided.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Not applicable. This is not an AI/CADe device submission that requires expert-established ground truth for a test set.
4. Adjudication Method for the Test Set
Not applicable.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. This submission is for a control material, not an AI/CADe device designed to assist human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
No, a standalone performance study was not done. This device is a control material, not an algorithm.
7. The Type of Ground Truth Used
Not applicable in the context of typical AI/CADe device evaluation using "ground truth" labels. For this control material, the "ground truth" equivalent would be the established specifications and performance of the predicate device against which the new device's characteristics are compared for substantial equivalency.
8. The Sample Size for the Training Set
Not applicable. This is a control material, not an AI/CADe device that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable.
§ 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.