(32 days)
Urine Chemistry Control, Level 2, 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 2, 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 2 will be offered in 10.0 mL and 25.0 mL fill vials.
The provided text describes a Urine Chemistry Control, Level 2 device, which is a quality control material, not an AI or imaging device. Therefore, many of the requested fields regarding acceptance criteria, study design, expert involvement, and reader studies are not applicable.
Here's the relevant information that can be extracted from the provided document:
1. Acceptance Criteria and Reported Device Performance
For this quality control device, the "acceptance criteria" are primarily related to its design and intended use being substantially equivalent to a predicate device. The "performance" in this context refers to its ability to serve as a quality control material, which is implied by its composition and intended use.
| Device Characteristic | Acceptance Criteria / Predicate Device Performance | Reported Device Performance (Urine Chemistry Control, Level 2) |
|---|---|---|
| Intended Use | Assayed quality control urine for monitoring precision of laboratory testing procedures. (Predicate: Lyphochek® Quantitative Urine Control, Abnormal) | Assayed quality control urine for monitoring performance of urine chemistry test procedures. |
| Matrix | Human Urine (Predicate) | Human Urine |
| Form | Lyophilized (Predicate) | Lyophilized |
| Analytes | 51 analytes (Predicate) | 48 analytes of clinical significance that may be found in urine. |
| Storage | 2-8°C (Predicate) | 2-8°C |
| Stability | Until expiration date noted on vial label. (Predicate) | Until expiration date noted on vial label. |
Conclusion from document: The device is concluded to be "substantially equivalent" to the predicate device due to the comparison of intended uses and physical properties.
2. Sample size used for the test set and the data provenance
Not applicable. This is a quality control material evaluation, not a diagnostic device with a test set of patient data. The "comparison" was made against a predicate device's characteristics.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. Ground truth for a test set is not relevant for this type of device submission.
4. Adjudication method for the test set
Not applicable.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This is not an AI or imaging diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable in the conventional sense of diagnostic device evaluation. The "ground truth" for this product, if one could apply the term, would be the established performance and characteristics of the predicate device (LYPHOCHEK® QUANTITATIVE URINE CONTROL BIO-RAD Laboratories K-880495) and the standard analytical methods used to verify the composition and stability of the control material itself.
8. The sample size for the training set
Not applicable. This is not an AI or machine learning 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.