(169 days)
Prealbumin/Ceruloplasmin Control Set (Precinorm/Precipath PC) is used for quality control by monitoring accuracy and precision for the quantitative methods as specified in the enclosed value sheet.
Proprietary name: Prealbumin/Ceruloplasmin Control Set
Common name: Precinorm/Precipath PC
Classification name: Multi-Analyte Controls, All Kinds (assayed and unassayed) in Class I
Matrix: Human serum with material of biological origin as specified
Format: Lyophilized
Handling: Reconstitute with exactly 1.0 mL of distilled water and allow to stand closed for 30 minutes to reconstitute, and then mix gently.
This submission describes the Prealbumin/Ceruloplasmin Control Set (Precinorm/Precipath PC), a Class I device used for quality control by monitoring the accuracy and precision of quantitative methods for Prealbumin and Ceruloplasmin. The submission focuses on demonstrating substantial equivalence to a predicate device, Precinorm PUC (K040280), rather than providing detailed acceptance criteria and a standalone study for the device's performance.
Here's the breakdown of the information requested, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The provided submission does not specify quantitative acceptance criteria or provide detailed performance data for the Prealbumin/Ceruloplasmin Control Set. Instead, it states that "The Prealbumin/Ceruloplasmin Control Set was evaluated for value assignment and stability. A summary of the evaluation studies is provided in the Performance Characteristics Section of this submission." However, the "Performance Characteristics Section" itself is not included in the provided document.
The document focuses on comparing the new device to a predicate device, noting similarities in intended use and stability, and differences in matrix, format, and handling.
| Characteristic | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Intended Use | To be used for quality control by monitoring accuracy and precision for quantitative methods as specified in the enclosed value sheet. | Prealbumin/Ceruloplasmin Control Set (Precinorm/Precipath PC) is used for quality control by monitoring accuracy and precision for the quantitative methods as specified in the enclosed value sheet. (Matches intended use of predicate) |
| Stability | Unopened: Store at 2-8°C until expiration date. | |
| Reconstituted: |
- At 15 – 25 °C: up to 8 hrs
- At 2-8°C: 2 days
- At (-15)-(-25)°C: 2 weeks (freeze only once) | Matches the described stability, which is comparable but not identical to the predicate (Opened: Stable for 4 weeks at 2-8°C for predicate). The exact performance to meet these criteria is not detailed. |
| Value Assignment | Not specified. | "Evaluated for value assignment" (Details not provided). |
| Accuracy & Precision | Not specified. | "monitoring accuracy and precision" (Performance metrics not provided). |
2. Sample Size Used for the Test Set and Data Provenance
This information is not provided in the given document. The submission mentions "evaluations summary" and "performance characteristics," but no details on sample size, data country of origin, or whether the study was retrospective or prospective are included.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This information is not applicable and not provided. This device is a quality control material for laboratory assays, not an imaging or diagnostic device that requires expert interpretation for establishing ground truth on patient data. Ground truth for control materials typically relates to the assigned values of the analytes within the control, which are established through rigorous analytical methods, often by the manufacturer.
4. Adjudication Method for the Test Set
This information is not applicable and not provided. As explained above, this device does not involve a diagnostic decision or interpretation of patient data that would require an adjudication method.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance
This information is not applicable and not provided. This device is a quality control material, not an AI-powered diagnostic device, and therefore, an MRMC study comparing human readers with and without AI assistance is irrelevant to its purpose.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This information is not applicable and not provided. This device is a laboratory control material, not an algorithm.
7. The Type of Ground Truth Used
The ground truth for this type of device (quality control material) would primarily be the assigned values of the analytes (Prealbumin and Ceruloplasmin) within the control material. These values are established through the manufacturer's value assignment process, which typically involves multiple measurements using reference methods and/or calibrated instruments. The document states the device "was evaluated for value assignment," implying this process was conducted, but specific details are not provided.
8. The Sample Size for the Training Set
This information is not applicable and not provided. This device is a quality control material, not a machine learning algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable and not provided. (See point 8).
§ 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.