(31 days)
The IGG Flex™ reagent cartridge for the Dimension® clinical chemistry system is an in vitro diagnostic test intended to quantitatively measure immunoglobulin G (IgG) in serum and plasma.
The IGG Flex™ reagent cartridge for the Dimension® clinical chemistry system is a quantitative, turbidimetric assay based on the precipitation of IgG by its polyclonal antibodies.a IgG 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 nm. The increase in turbidity is proportional to the concentration of IgG and it is calculated from a five point calibration curve.
Here's a breakdown of the acceptance criteria and the study information for the IGG Flex™ Reagent Cartridge, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Substantial equivalence to the predicate device (Beckman Array® Immunoglobulin G Method). This is primarily assessed through correlation of results. | Correlation Coefficient: 0.993 |
| Slope: 1.00 | |
| Intercept: -12.8 mg/dL | |
| (These metrics demonstrate a very strong linear relationship and agreement between the IGG Flex™ and the predicate device, indicating substantial equivalence.) | |
| Intended Use: Quantitatively measure immunoglobulin G (IgG) in human serum and plasma. | The device performed this function in the study, yielding quantitative IgG measurements comparable to the predicate device. |
| Methodology: Immunoprecipitation with Bichloromatic endpoint (340 and 700 nm) (turbidimetry). | The device successfully utilizes this methodology as described. Performance metrics (correlation, slope, intercept) indicate that this methodology is effective and comparable to the predicate's nephelometry. |
| Sample Type: Serum and plasma. | The study explicitly states that 111 clinical patient samples were used, implying the use of serum and/or plasma as per the device's intended use. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: 111 clinical patient samples.
- Data Provenance: The text does not explicitly state the country of origin. It indicates "clinical patient samples," suggesting real-world patient data. The study is retrospective in nature, as it involves comparing the new device's measurements on existing "clinical patient samples" to a legally marketed predicate device.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the document. For in vitro diagnostic (IVD) devices like this, the "ground truth" is typically established by measurements from a well-characterized, legally marketed predicate device, rather than direct expert interpretation of raw data. The predicate device's results serve as the reference.
4. Adjudication Method for the Test Set
This information is not applicable/provided as the study design is a direct comparison to a predicate device, not an interpretation-based task requiring expert adjudication. The comparison method involved running the same samples on both devices and analyzing the statistical correlation of the quantitative results.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is more common for imaging devices where human readers interpret diagnostic images. The IGG Flex™ is an in vitro diagnostic reagent and system, and its performance is assessed through quantitative agreement (correlation) with a predicate device, not by human reader interpretation. Therefore, there is no effect size of how much human readers improve with AI vs without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, in effect, a standalone performance study was done. The IGG Flex™ Reagent Cartridge, as an in vitro diagnostic assay on the Dimension® clinical chemistry system, operates as a standalone automated system. The reported performance (correlation, slope, intercept) reflects the direct output of this system compared to the predicate device, without direct human intervention in the result generation or interpretation for the comparison study itself. While humans operate the instruments, the "performance" here refers to the analytical capabilities of the assay and instrument combination.
7. The Type of Ground Truth Used
The "ground truth" for the comparative study was established by the measurements obtained from the legally marketed predicate device: the Beckman Array® Immunoglobulin G Method. The comparison was directly between the quantitative results of the IGG Flex™ system and the Beckman Array® system for the same patient samples.
8. The Sample Size for the Training Set
The document does not provide information about a specific "training set" or "training set sample size" for the IGG Flex™ reagent. This is typical for IVD assays. The development of such assays involves analytical validation, calibration, and optimization, which would use various samples, but these are not usually referred to as a "training set" in the same way machine learning algorithms are. The reported study focuses on clinical validation/comparison.
9. How the Ground Truth for the Training Set Was Established
Since no specific "training set" is mentioned in the context of algorithm development (as it's not an AI/ML device), the concept of establishing ground truth for a training set in that sense is not applicable here. The ground truth for the reported study (comparison to predicate) was the Beckman Array® Immunoglobulin G Method results, as explained in point 7. For the initial development and calibration of the IGG Flex™ assay itself, ground truth would have been established through a combination of analytical methods, reference materials, and established laboratory practices to ensure accurate IgG quantification.
§ 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).