(22 days)
Liquichek Urine Chemistry Control is intended for use as an assayed quality control urine to monitor the precision of laboratory testing procedures for the analytes listed in the package insert.
Liquichek Urine Chemistry Control is prepared from human urine with added constituents of human and animal origin, chemicals, preservatives and stabilizers. The control is provided in liquid form for convenience.
The provided document describes a 510(k) premarket notification for the Bio-Rad Laboratories Liquichek Urine Chemistry Control. This document is for a quality control material, not a diagnostic device with complex performance criteria or AI components. Therefore, many of the requested elements for a diagnostic device performance study (e.g., sample size for test sets, data provenance, ground truth establishment, MRMC studies, standalone algorithm performance, training set details) are not applicable to this type of submission.
Here is an analysis based on the information provided, highlighting the applicable criteria and findings for this specific type of device (a quality control material):
1. Table of Acceptance Criteria and Reported Device Performance
For this quality control material, the "acceptance criteria" are related to its stability and its comparability to a predicate device for its intended use. The "reported device performance" demonstrates it meets these criteria.
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance |
|---|---|---|
| Intended Use Equivalence | To be used as an assayed quality control urine to monitor the precision of laboratory testing procedures for listed analytes. | The new device has the same intended use as the predicate device (K020817). |
| Matrix Equivalence | Human urine matrix. | The new device is prepared from human urine, matching the predicate. |
| Form Equivalence | Liquid form. | The new device is in liquid form, matching the predicate. |
| Open Vial Stability | 30 days at 2°C to 8°C. | Stability studies confirmed 30 days at 2°C to 8°C. |
| Shelf Life Stability | 2°C to 8°C until expiration date (24 months). | Stability studies confirmed 24 Months at 2°C to 8°C. |
| Performance Similarity | Performs similarly to the predicate device. | The submission states "performs similarly as the predicate device" based on value assignment derived from replicate analyses by the manufacturer and/or independent laboratories. (Specific quantitative comparison data is not provided in this summary but is implied to be on file). |
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Not explicitly stated as a separate "test set" in the context of a diagnostic device. For quality control materials, "testing" involves stability studies and value assignment. The "value assignment" states it used "replicate analyses" and a "representative sampling of this lot of product." The exact number of replicates or product units sampled is not specified.
- Data Provenance: The studies were performed by "the manufacturer and/or independent laboratories." No specific country of origin is mentioned for the data, and it is assumed to be retrospective to the manufacturing process for the specific lot.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable. For a quality control material, "ground truth" is established through analytical methods and value assignments, not expert consensus on interpretations like in diagnostic imaging. The values are assigned based on "replicate analyses" using "manufacturer supported reagents."
4. Adjudication method for the test set
- Not Applicable. As there are no expert interpretations or subjective assessments involved in the performance evaluation of a quality control material, no adjudication method would be used. Value assignment is typically based on rigorous statistical analysis of quantitative measurements.
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 a quality control material, not a diagnostic device that involves human readers or AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is a quality control material. There is no algorithm involved.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- For quality control materials, the "ground truth" (or accepted reference values) for the analytes within the control is established through analytical testing and quantitative measurement. The document states, "The mean values and the corresponding ±3SD ranges printed in the insert were derived from replicate analyses and are specific for this lot of product. The tests listed were performed by the manufacturer and/or independent laboratories using manufacturer supported reagents." This indicates a measurement-based analytical ground truth.
8. The sample size for the training set
- Not Applicable. This is a quality control product; there is no machine learning "training set."
9. How the ground truth for the training set was established
- Not Applicable. As there is no training set.
§ 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.