(26 days)
IGALC reagent, when used in conjunction with IMMAGE® Immunochemistry Systems and Cerebrospinal Fluid Protein Calibrator, is intended for quantitative determination of Low Concentration Immunoglobulin A (IGALC) in human serum or cerebrospinal fluid (CSF) by rate nephelometry.
The IMMAGE® Low Concentration Immunoglobulin A (IGALC) Reagent and Cerebrospinal Fluid Calibrator are designed for optimal performance on the IMMAGE® Immunochemistry Systems. It is intended for the quantitative determination of immunoglobulin A in serum and cerebrospinal fluid.
The provided text describes a 510(k) submission for a medical device, which is primarily focused on demonstrating substantial equivalence to a predicate device rather than presenting a detailed study proving the device meets specific acceptance criteria with quantifiable metrics. The submission states that "Performance data from validation testing supports equivalency," but it does not provide the actual data, acceptance criteria, or a description of the study design in the provided text.
Therefore, many of the requested details cannot be extracted from the given input.
Here's a breakdown of what can and cannot be answered:
1. Table of acceptance criteria and the reported device performance:
- Cannot be determined. The document states "Performance data from validation testing supports equivalency" but does not provide specific acceptance criteria (e.g., accuracy, precision targets) or the actual reported performance values for the device. The modification was "to reflect performance of the current reagent production processes," implying the performance itself was not significantly changed from the predicate.
2. Sample size used for the test set and the data provenance:
- Cannot be determined. The document does not provide any information about the sample size of the test set or the origin of the data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable/Cannot be determined. This device is a diagnostic reagent for quantitative determination of Immunoglobulin A. The "ground truth" would typically be established by a reference method or known concentrations, not by expert interpretation in the way, for example, a radiology image would be. No information is provided about how the ground truth for any validation was established.
4. Adjudication method for the test set:
- Not applicable/Cannot be determined. Similar to point 3, adjudication methods like 2+1 or 3+1 are typically used for subjective assessments (e.g., image interpretation) where multiple experts might disagree. This is not relevant to a quantitative chemical assay.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and 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 reagent for an automated immunoassay system, not an AI-assisted diagnostic tool that human readers would interact with.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is a reagent kit used on an automated instrument. Its performance is inherently standalone in the sense that the instrument processes the sample without human interpretation of raw data, but it's not an "algorithm only" in the modern AI sense. The performance of the "device" (reagent and system together) is what's being evaluated.
7. The type of ground truth used:
- Cannot be determined. While it would logically be against a reference method or known concentration standards for a quantitative assay, the document does not explicitly state the type of ground truth used for validation.
8. The sample size for the training set:
- Not applicable/Cannot be determined. This device is a chemical reagent, not a machine learning model, so there isn't a "training set" in the computational sense. The "training" would refer to the development and optimization of the reagent formulation and assay parameters, but sample sizes for this are not provided.
9. How the ground truth for the training set was established:
- Not applicable/Cannot be determined. As above, there is no "training set."
Summary of what can be extracted:
- Device Name: IMMAGE® Systems Low Concentration Immunoglobulin A (IGALC) Reagent
- Intended Use: Quantitative determination of Low Concentration Immunoglobulin A (IGALC) in human serum or cerebrospinal fluid (CSF) by rate nephelometry, when used with IMMAGE® Immunochemistry Systems and Cerebrospinal Fluid Protein Calibrator.
- Modification: The serum methods comparison data has been modified to reflect performance of the current reagent production processes. All other performance parameters remain unchanged.
- Equivalency Claim: Performance data from validation testing supports equivalency to the predicate device (IMMAGE Systems Low Concentration Immunoglobulin A Reagent, FDA 510(k) Number K993549).
The provided text is a 510(k) summary, which is typically a high-level overview. A full 510(k) submission would contain the detailed studies and data to support these claims, but that detailed information is not present in the given excerpt.
§ 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).