(21 days)
For use in monitoring the performance of the Vitros ECi Immunodiagnostic System when used for the in vitro qualitative detection of immunoglobulin G antibody to hepatitis C virus (anti-HCV) in human serum and plasma (heparin, EDTA or citrate). The performance of the Vitros Immunodiagnostic Products Anti-HCV Controls has not been established with any other anti-HCV assays.
The Virros Immunodiagnostic System uses luminescence as the signal in the qualitative detection The Pirod Hillians are many plasma. Coated microwells are used as the solid phase separation system.
The system is comprised of three main elements:
- The Viros Immunodiagnostic Products range of products, in this case Vitros Immunodiagnostic The / in of millians and Vitros Immunodiagnostic Products Calibrator, which are r routed by the Vitros Immunodiagnostic System to perform a Vitros assay. The Vitros Immunodiagnostic Products Anti-HCV Reagent Pack and Calibrator have been submitted for FDA review in PMA P010021.
- The Vitros Immunodiagnostic System instrumentation, which provides automated use of the immunoassay kits. The Vitros Immunodiagnostic System was cleared for market by a separate 510(k) pre-market notification (K962919).
- Common reagents used by the Vitros System in each assay. The Vitros Immunodiagnostic Products Signal Reagent and Vitros Immunodiagnostic Products Universal Wash Reagent were cleared as part of the Vitros Immunodiagnostic Products Total T3 510(k) pre-market notification (K964310).
The Vitros System and common reagents are dedicated specifically only for use with the Vitros Immunodiagnostic Products range of immunoassay products.
The provided text describes a 510(k) summary for the Vitros Immunodiagnostic Products Anti-HCV Controls. This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study proving the device meets specific performance acceptance criteria. Therefore, most of the requested information about acceptance criteria and study details are not available in the provided text.
Here is an analysis based on the available information:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state acceptance criteria or report specific device performance metrics in numerical terms that would typically be seen in a performance study. Instead, it focuses on comparing characteristics to a predicate device to establish substantial equivalence.
Table: Acceptance Criteria and Reported Device Performance (Based on provided text)
| Characteristic/Criterion | Acceptance Criteria (Implicit) | Reported Device Performance (Summary of Comparison to Predicate) |
|---|---|---|
| Intended Use | Must be similar to or compatible with predicate. | Vitros controls: monitoring performance of Vitros ECi system for in vitro qualitative detection of anti-HCV in human serum/plasma. |
| Predicate controls: estimate testing precision and detect errors for various analytes including anti-HCV; formulated for in vitro diagnostic kits. | ||
| Matrix of Controls | Must be similar to predicate for compatibility and appropriate control. | Vitros controls: Human serum with added antimicrobial agents. |
| Predicate controls: Human serum or plasma with added stabilizers and preservative. | ||
| Control Levels Offered | Must offer relevant control levels (e.g., positive, negative) | Vitros controls: Positive and negative. |
| Predicate controls: Positive (negative control available separately from BBI®). | ||
| Expected Values/Value Assignment | Must provide guidance on expected values for monitoring. | Vitros controls: Quoted mean value from ≥10 assays and standard deviation; values are lot specific. |
| Predicate controls: No assigned values; formulated for positive reactivity; specific levels vary among assays/labs. | ||
| Substantial Equivalence | Demonstrate substantial equivalence to predicate device. | The pre-market notification demonstrates that the Vitros Anti-HCV Controls are substantially equivalent to the predicate device Boston Biomedica, Inc. ACCURUN 1® Multi-Marker Positive Control. |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
The document does not provide details on a "test set" in the context of a performance study with a specific sample size. The statement "Each control has a quoted mean value derived from a minimum of 10 assays" suggests some internal testing was performed, but this is not described as a formal validation study with a defined test set. Data provenance (country, retrospective/prospective) is not mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
This information is not provided because the document describes a regulatory submission for a control material, not a diagnostic device requiring expert interpretation for ground truth establishment.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable, as no external "test set" or adjudication requiring expert input is described in the provided text.
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 device is a control material for an immunoassay system, not an AI-assisted diagnostic tool that would involve human readers or MRMC studies.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
This concept is not relevant to the described device. The "device" is a control reagent for an automated immunoassay system, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For control materials, the "ground truth" relates to the manufacturing specifications and known reactivity of the control. The document states that Vitros controls have "a quoted mean value derived from a minimum of 10 assays and a standard deviation," and "Values are lot specific." For the predicate, it's mentioned that controls "are formulated to produce positive reactivity." This implies that the ground truth for these controls is based on internal characterization and manufacturing processes to ensure they elicit expected responses within the intended assay. There is no external "ground truth" like pathology or expert consensus required for a control material in the same way it would be for a diagnostic test.
8. The sample size for the training set
Not applicable. This device is a control material, not a machine learning algorithm that requires a training set.
9. How the ground truth for the training set was established
Not applicable, as there is no training set for this type of device.
§ 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.