(111 days)
This product permits the quantitative in vitro diagnostic determination of Immunoglobulin G in serum and plasma on the ILab Clinical Chemistry System by turbidimetric immunoassay method. Measurement of IgG aids in the diagnosis of abnormal protein metabolism and the body's lack of ability to resist infectious agents.
quantex IgG: 8 x 6 mL anti-human IgG P/N 3000-22134; 2 x 100 mL Buffer P/N 3000-22130
Here's an analysis of the provided text regarding the quantex IgG device, focusing on the acceptance criteria and the supporting study:
The provided 510(k) summary is for an in vitro diagnostic device (IVD) and lacks the detailed performance data typically found in studies for diagnostic imaging or AI-driven devices. Therefore, many of the requested categories (e.g., sample size for test set, number of experts for ground truth, MRMC studies) are not applicable or cannot be extracted from this type of document.
Description of the Acceptance Criteria and Study for quantex IgG
This 510(k) summary describes the quantex IgG, an in vitro diagnostic test for the quantitative determination of Immunoglobulin G in serum and plasma. The device functions on the ILab Clinical Chemistry System via a turbidimetric immunoassay method. The primary purpose of this 510(k) submission is to demonstrate substantial equivalence to a predicate device, the IL Test™ IgG (K920006/B).
The acceptance criteria, in this context, are implicitly tied to demonstrating performance comparable to the predicate device to establish substantial equivalence.
1. Table of Acceptance Criteria and Reported Device Performance
Given the nature of the submission (510(k) for an IVD), the "acceptance criteria" are not explicitly stated as distinct numerical thresholds for sensitivity, specificity, etc., as one might find for imaging devices. Instead, the acceptance criterion for substantial equivalence is demonstrated through a method comparison study showing a strong correlation with the predicate device.
| Acceptance Criteria (Implied for Substantial Equivalence via Method Comparison) | Reported Device Performance (quantex IgG vs. IL Test™ IgG) |
|---|---|
| Strong correlation with predicate device | Correlation (r) = 0.9644 |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Forty-seven (47) serum samples.
- Data Provenance: The document does not explicitly state the country of origin. It is a comparative performance study, implying the samples were processed on both the new device (quantex IgG on ILab) and the predicate device (IL Test™ IgG on Monarch Clinical Chemistry System). The study appears to be prospective in the sense that these specific samples were run to demonstrate equivalence, but the origin of the samples themselves (e.g., from a retrospective bank or prospectively collected for this study) is not specified.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
N/A. For IVD devices like this, the "ground truth" is typically the measurement obtained from a reference method or a predicate device. There are no human experts involved in establishing a subjective ground truth measurement for IgG levels.
4. Adjudication Method for the Test Set
N/A. Adjudication methods (like 2+1, 3+1) are relevant for subjective interpretations, often in imaging studies. For quantitative IVDs, the measurements are objective, and thus, no adjudication method is applicable.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
N/A. MRMC studies are used for evaluating the performance of human readers, sometimes with and without AI assistance, especially in diagnostic imaging. This document describes an IVD measuring an analyte and does not involve human readers interpreting results in a subjective manner.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
While the device's operation is "standalone" in the sense that it automates the measurement of IgG, the performance metrics reported here are specifically comparative to a predicate device. The output (an IgG concentration) is a direct, objective measurement from the algorithm/instrument, without a human interpretation step that would then be compared to an "AI-assisted" human interpretation.
7. The Type of Ground Truth Used
The "ground truth" in this context is established by the predicate device, IL Test™ IgG, which itself would have been previously cleared by the FDA and accepted as a reliable method for measuring IgG levels. The study aims to show that the new device's measurements are essentially the same as those from the established predicate.
8. The Sample Size for the Training Set
N/A. This 510(k) summary describes a new diagnostic kit for an existing assay type (turbidimetric immunoassay for IgG). It does not involve a machine learning algorithm that requires a "training set" in the conventional sense. The "training" of the instrument, if any, would refer to calibration procedures to ensure accurate measurements, but not a large dataset for algorithm learning.
9. How the Ground Truth for the Training Set Was Established
N/A. As there is no "training set" for a machine learning algorithm, there is no ground truth established for it in this context. The instrument's calibration would rely on reference materials or calibrated controls, not a "ground truth" in the diagnostic performance evaluation context.
§ 866.5510 Immunoglobulins A, G, M, D, and E immunological test system.
(a)
Identification. An immunoglobulins A, G, M, D, and E immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the immunoglobulins A, G, M, D, an E (serum antibodies) in serum. Measurement of these immunoglobulins aids in the diagnosis of abnormal protein metabolism and the body's lack of ability to resist infectious agents.(b)
Classification. Class II (performance standards).