(31 days)
The IGA Flex™ reagent cartridge for the Dimension® Clinical Chemistry System is an in vitro diagnostic device intended to quantitatively measure immunoglobulin A in serum and plasma.
The IGA Flex™ reagent cartridge for the Dimension® clinical chemistry system is a quantitative, turbidimetric assay based on the precipitation of IgA by its polyclonal antibodies.a
IgA from serum or plasma reacts with its polyclonal antibodies to form an immunoprecipitate. Addition of polyethylene glycol accelerates the formation of the precipitate. Turbidity created by immunoprecipitation is measured as bichromatic endpoint measurements at 340 and 700 um. The increase in turbidity is proportional to the concentration of IgA and it is calculated from a five point calibration curve.
PEG IgA + Antibody ------------------------> IgA-Antibody Complex
a The antibody is manufactured by Dade Behring, Marburg, Germany
The provided text describes a 510(k) submission for the IGA Flex™ Reagent Cartridge, comparing it to a predicate device. Here's a breakdown of the acceptance criteria and study information:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Strong correlation with predicate device | Correlation Coefficient: 0.983 |
| Good agreement in quantitative measurements | Slope: 0.96 |
| Minimal bias compared to predicate device | Intercept: 3.4 mg/dL |
Note: The document implies these criteria by presenting the results of the comparison study as evidence of substantial equivalence. Explicit acceptance criteria values (e.g., "correlation coefficient must be greater than 0.95") are not directly stated but are inferred from the conclusion of substantial equivalence based on these high values.
2. Sample size used for the test set and the data provenance
- Sample Size (Test Set): 100 clinical patient samples
- Data Provenance: The samples are referred to as "clinical patient samples," suggesting they were collected from patients, but the country of origin is not specified. The study is retrospective, as it involves a "split sample comparison" where existing samples would have been analyzed by both devices. It is also prospective relative to the device submission date of 1999.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not provided in the document. The "ground truth" for this type of device (quantitative measurement of a biomarker) is typically established by the predicate device's measurement, which is considered a reference standard rather than expert consensus on individual cases.
4. Adjudication method for the test set
This information is not applicable and therefore not provided. Adjudication methods (e.g., 2+1, 3+1) are typically used in studies where human interpretation or consensus is required to establish ground truth or evaluate different interpretations, such as in image analysis or diagnostic assessments. For a quantitative immunoassay comparing a new device to a predicate, the comparison of numerical outputs doesn't involve adjudication in this sense.
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
This is not applicable. The device is an automated in vitro diagnostic system, not an AI-assisted diagnostic tool that requires human readers. Therefore, an MRMC study and analysis of human reader improvement with AI assistance are irrelevant to this submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, a standalone performance study was done. The "split sample comparison" between the IGA Flex™ reagent cartridge and the Beckman Immunoglobulin A assay represents a direct comparison of the performance of the new device (algorithm/system) against an established method, without human intervention in the measurement process itself.
7. The type of ground truth used
The "ground truth" for the performance evaluation was the measurements obtained from the predicate device, the Beckman Array® Immunoglobulin A Method. In this context, the predicate device acts as the reference standard against which the new device's measurements are compared.
8. The sample size for the training set
This information is not provided in the document. For a traditional immunoassay device like this, there isn't typically a "training set" in the machine learning sense. Any initial assay development or calibration would rely on characterized samples or standards, but those details are not part of this summary.
9. How the ground truth for the training set was established
This information is not provided and is largely not applicable in the typical sense for this type of device. If developmental samples were used, their "ground truth" would likely be based on established laboratory methods or certified reference materials, but these details are beyond the scope of this 510(k) summary.
§ 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).