(53 days)
Lyphochek Tumor Marker Plus Control is intended for use as an assayed quality control serum to monitor the precision of laboratory testing procedures for the analytes listed in the package insert.
Lyphochek Tumor Marker Plus Control is intended for use as an assayed quality control material to monitor the precision of laboratory testing procedures for the analytes listed in the package insert. This control is substantially equivalent to the following quality control material that is currently in the market: Lyphochek Tumor Marker Control Bio-Rad Laboratories Irvine, California 92618 510(k) Number: K011579. The new device is lyophilized serum and has 3 levels (1, 2, and 3).
This is a 510(k) premarket notification for a quality control material, not a diagnostic device that performs analysis on patient samples. Therefore, many of the requested categories (sample size, expert qualifications, adjudication, MRMC studies, standalone performance) are not applicable.
Here's the information that can be extracted from the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
For a quality control material, acceptance criteria typically relate to the stability of the analytes within the control. The studies performed are stability studies.
| Acceptance Criteria (Stated Claims) | Reported Device Performance (Stability) |
|---|---|
| Shelf Life at 2 to 8°C: All analytes stable for 3 years. | All analytes are stable for 3 years at 2 to 8°C. |
| Reconstituted Stability at 2 to 8°C: | Once reconstituted and stored tightly capped at 2 to 8°C: |
| - All analytes stable for 14 days. | - All analytes stable for 14 days. |
| - CEA stable for 11 days. | - Carcinoembryonic Antigen (CEA) is stable for 11 days. |
| - Free and Total PSA stable for 7 days. | - Free and Total PSA are stable for 7 days. |
| - Thyroglobulin (Tg) stable for 5 days. | - Thyroglobulin (Tg) is stable for 5 days. |
| - ACTH and Calcitonin should be assayed immediately. | - ACTH and Calcitonin should be assayed immediately following reconstitution. |
| Reconstituted Stability at -20 to -70°C: | Once reconstituted and stored tightly capped at -20 to -70°C: |
| - All analytes stable for 30 days. | - All analytes are stable for 30 days. s- |
| - No stability claims for ACTH and Calcitonin at -20 to -70°C. | - There are no stability claims at -20 to -70°C for ACTH and Calcitonin. |
2. Sample size used for the test set and the data provenance
The document refers to "Stability studies" as the basis for these claims. It does not provide specific sample sizes (e.g., number of vials, number of replicates, duration of storage for testing points) for these studies. It also does not specify the country of origin or whether they were retrospective or prospective, though stability studies for product claims are inherently prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This is a quality control material where "ground truth" refers to the expected concentration/stability of analytes, established through laboratory methods and internal validation, not expert interpretation of clinical data.
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 a quality control material, not an AI-powered diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a quality control material.
7. The type of ground truth used
The ground truth used for a quality control material like this would be derived from laboratory reference methods and certified reference materials, where applicable, to determine the assigned values and assess the stability of the included analytes over time and under various storage conditions. The stability studies (shelf life and reconstituted stability) are described as the basis for the performance claims.
8. The sample size for the training set
Not applicable. This is not a machine learning or AI-based device.
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.