(24 days)
Quest Diagnostics Tumor Marker Control is intended for use as a quality control serum to monitor the precision of laboratory testing procedures for the analytes listed in the package insert.
This product is prepared from human serum with added chemicals, constituents of human and animal origin. This product is provided in lyophilized form for added stability.
Here's a breakdown of the acceptance criteria and the study information from the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Acceptance Criteria (New Device) | Reported Device Performance (New Device) |
|---|---|---|
| Open Vial Stability | 14 days at 2°C to 8°C | 14 days at 2°C to 8°C |
| Post-Reconstitution & Freezing Stability | 30 days at -10°C to -20°C | 30 days at -10°C to -20°C |
| Shelf Life | Three years and three months when stored at 2°C to 8°C | Three years and three months when stored at 2°C to 8°C |
| Intended Use | To monitor the precision of laboratory testing procedures for listed analytes. | Intended for use as a quality control serum to monitor the precision of laboratory testing procedures for the analytes listed in the package insert. |
| Form | Lyophilized | Lyophilized |
| Matrix | Human Serum | Human Serum |
| Preservatives | Does not contain preservatives | Does not contain preservatives |
| Storage (Unopened) | 2°C to 8°C until expiration date | 2°C to 8°C until expiration date |
Note: The document primarily focuses on establishing "substantial equivalence" to a predicate device, rather than explicit numerical performance acceptance criteria common in diagnostic accuracy studies. The core acceptance criteria for this type of device are related to its stability and intended use aligning with the predicate.
2. Sample Size Used for the Test Set and Data Provenance
The provided document does not explicitly state the sample size used for the test set in the stability studies. It only mentions that "Stability studies have been performed to determine the open vial stability and shelf life for the Quest Diagnostics Tumor Marker Control."
The document also does not specify the data provenance (e.g., country of origin, retrospective or prospective).
3. Number of Experts Used to Establish Ground Truth and Qualifications
This information is not applicable to this type of device and study. The device is a quality control material, and its "ground truth" relates to its inherent stability and consistency, demonstrated through laboratory testing rather than expert-derived diagnoses.
4. Adjudication Method
This information is not applicable to this type of device and study. Adjudication methods are used in studies involving human interpretation or diagnosis to resolve discrepancies, which is not the nature of a quality control material evaluation.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic devices that involve human interpretation and aims to assess the impact of AI assistance on human reader performance. This document concerns a quality control material.
6. If a Standalone Study Was Done
Yes, a standalone study (i.e., algorithm only without human-in-the-loop performance) was effectively done in the form of stability studies. These studies evaluated the intrinsic properties of the "Quest Diagnostics Tumor Marker Control" itself (its stability under various conditions) without human interpretation being the primary endpoint. The device doesn't have an "algorithm" in the traditional sense, but its performance as a quality control is assessed standalone.
7. The Type of Ground Truth Used
The "ground truth" for this device is established through:
- Laboratory Testing/Reference Methods: The stability and concentration of the analytes within the control material would be measured using established laboratory methods over time and under various storage conditions. The expected values, as determined by these methods at the time of manufacture and over the claimed stability period, serve as the ground truth against which the device's performance is assessed.
- Comparison to Predicate Device: The ultimate "ground truth" for regulatory purposes in this 510(k) submission is demonstrating substantial equivalence to the "Lyphochek Tumor Marker Control." This implies that the new device's stability and characteristics should fall within acceptable parameters relative to the predicate, as determined by industry standards and established laboratory practices for quality control materials.
8. The Sample Size for the Training Set
The provided document does not mention a training set. This is because the device is a quality control material, not an AI/ML algorithm that requires training data. The "study" here involves analytical performance (stability) rather than a learning process.
9. How the Ground Truth for the Training Set Was Established
As there is no training set for this type of device, this question is 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.