(36 days)
Lyphochek Maternal Serum Control is intended for use as an assayed quality control to monitor the precision of laboratory testing procedures for the analytes listed in the package insert.
Lyphochek Maternal Serum Control is prepared from human serum with added constituents of human origin, pure chemicals and preservatives. The control is provided in lyophilized form for increased stability.
The provided text is a 510(k) summary for the Bio-Rad Lyphochek Maternal Serum Control, which is a quality control device. It does not describe a study involving patient data, clinical outcomes, or human readers for diagnostic purposes to establish acceptance criteria in the typical sense of a medical diagnostic device's performance. Instead, it compares the technological characteristics of the new device to a predicate device to claim substantial equivalence.
Therefore, many of the requested elements for describing "acceptance criteria and the study that proves the device meets the acceptance criteria" are not applicable to this document. The "device performance" here refers to its physical and chemical characteristics as a control serum, rather than its diagnostic accuracy.
Here's an analysis based on the provided text, highlighting what is available and what is not:
1. Table of Acceptance Criteria and Reported Device Performance
The document doesn't present "acceptance criteria" in terms of clinical performance metrics like sensitivity, specificity, accuracy, or concordance. Instead, it compares the characteristics of the investigational device (Lyphochek Maternal Serum Control) to a predicate device (Lyphochek Immunoassay Plus Control) to demonstrate substantial equivalence. The "performance" being described relates to the control's properties.
| Characteristic | Bio-Rad Lyphochek Maternal Serum Control (Investigational Device) | Bio-Rad Lyphochek Immunoassay Plus Control (Predicate Device) |
|---|---|---|
| Intended Use | An assayed quality control serum to monitor the precision of laboratory testing procedures for the analytes listed in the package insert. | An assayed quality control serum to monitor the precision of laboratory testing procedures for the analytes listed in the package insert. |
| Form | Lyophilized | Lyophilized |
| Open Vial Claim | 10 days when stored tightly capped at 2-8°C. | 7 days when stored tightly capped at 2-8°C with exceptions for certain analytes (3 days for C-Peptide, Folate, PSA; immediately for ACTH, Calcitonin, Gastrin). |
| Matrix | Human serum | Human serum |
| Storage | 2-8°C | 2-8°C |
| Analytes | AFP (Alpha-Fetoprotein), Estriol, Free, HCG-Beta Subunit | AFP (Alpha-Fetoprotein), Estriol, Free, HCG-Beta Subunit, Plus other analytes. |
Acceptance Criteria Implied: The acceptance criteria are implicitly that the investigational device's characteristics (intended use, form, open vial claim, matrix, storage, and key analytes) are either identical to or demonstrably equivalent to the predicate device to ensure it performs its function as a quality control. For the open vial claim, the acceptance criteria for the investigational device seems to be that it is stable for at least as long as the predicate for common analytes, or that any differences are well-supported and acceptable.
Study Proving Acceptance Criteria: The document describes a comparison, not a formal study in the sense of a clinical trial. The "study" here is the declaration of these comparative characteristics. The "proof" is the presented table and the assertion of substantial equivalence.
2. Sample Size Used for the Test Set and Data Provenance
This is not applicable. There is no "test set" of patient data or clinical samples in the traditional sense for evaluating diagnostic accuracy. The device itself is a control material, and its characteristics are evaluated (e.g., stability, matrices). The document does not specify sample sizes for these internal evaluations of the control material's properties.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This is not applicable. "Ground truth" in the context of diagnostic accuracy via expert consensus is not relevant for a quality control material where performance is assessed by its chemical and physical properties against a standard or predicate.
4. Adjudication Method for the Test Set
This is not applicable, as there is no "test set" requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
This is not applicable. MRMC studies are used to evaluate the diagnostic performance of devices, often involving human readers, which is not the purpose of a quality control device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This is not applicable. The Lyphochek Maternal Serum Control is a physical reagent, not an algorithm.
7. The Type of Ground Truth Used
The "ground truth" for a quality control material's characteristics (like stability or composition) would be established through established laboratory testing methodologies, analytical chemistry, and stability studies. The document does not explicitly detail these methods for the new device, but it implies they were done to support the presented characteristics, and presumably, industry standards for quality control manufacturing were followed. For the purpose of substantial equivalence, the "ground truth" is essentially the established characteristics of the predicate device.
8. The Sample Size for the Training Set
This is not applicable. There is no "training set" as this is not an AI/ML device or a device that learns from data.
9. How the Ground Truth for the Training Set Was Established
This is not applicable for the reasons stated above.
In summary: The provided 510(k) summary focuses on demonstrating substantial equivalence of a quality control material to a legally marketed predicate device based on technological characteristics. It does not involve a clinical study to assess diagnostic performance against patient outcomes or expert interpretations, and therefore, many of the typical acceptance criteria and study details for such devices are not present in this document. The "acceptance criteria" are the characteristics of the predicate device, and the "study" is the comparison made by the manufacturer to those characteristics.
§ 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.