(105 days)
The IMMAGE® Immunochemistry System Low Concentration Immunoglobulin A (IGALC) Reagent, when used in conjunction with Beckman Coulter's IMMAGE® Immunochemistry Systems and Cerebrospinal Fluid Protein Calibrator, is intended for the quantitative determination of human immunoglobulin A in serum and cerebrospinal fluid 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.
This is a premarket notification for new reagents and a calibrator for the Beckman Coulter IMMAGE Immunochemistry System, not a medical device in the typical sense of needing extensive clinical trials with human subjects. The acceptance criteria and performance data presented here are for the analytical performance of the diagnostic reagents.
Here's a breakdown of the requested information based on the provided document:
Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" in a separate section with numerical targets. Instead, it presents "Summary of Performance Data" including method comparison results (slope, intercept, correlation coefficient) and imprecision (CV%). The implicit acceptance criteria would be that these performance metrics demonstrate substantial equivalence to the predicate devices.
Here's the performance data as reported:
Method Comparison Data (Implicit Acceptance Criteria: Close to 1 for Slope, Close to 0 for Intercept, High Correlation Coefficient)
| Test | N | Slope | Intercept | Mean (IGALC) mg/L | Mean (Predicate) mg/L | Correlation Coefficient |
|---|---|---|---|---|---|---|
| Serum: IMMAGE IGALC Reagent vs. IMMAGE IGA | 50 | 0.973 | 91.02 | 2035 | 1999 | 0.984 |
| CSF: IMMAGE IGALC Reagent vs. Behring N Latex IgA | 50 | 1.056 | 0.56 | 6.59 | 5.72 | 0.991 |
Estimated IMMAGE System IGALC Reagent Imprecision (Serum) (Implicit Acceptance Criteria: Low %CV)
| PRECISION | SAMPLE | N | MEAN (mg/L) | SD (mg/L) | % CV |
|---|---|---|---|---|---|
| Within-Run | Low | 80 | 334 | 12.7 | 3.8 |
| Mid | 80 | 1818 | 60.3 | 3.3 | |
| High | 80 | 2922 | 89.7 | 3.1 | |
| Total | Low | 80 | 334 | 15.2 | 4.5 |
| Mid | 80 | 1818 | 64.7 | 3.6 | |
| High | 80 | 2922 | 103.3 | 3.5 |
Estimated IMMAGE System IGALC Reagent Imprecision (CSF) (Implicit Acceptance Criteria: Low %CV)
| PRECISION | SAMPLE | N | MEAN (mg/L) | SD (mg/L) | % CV |
|---|---|---|---|---|---|
| Within-Run | Low | 80 | 5.06 | 0.188 | 3.7 |
| Mid | 80 | 29.3 | 0.72 | 2.5 | |
| High | 80 | 59.8 | 2.29 | 3.8 | |
| Total | Low | 80 | 5.06 | 0.208 | 4.1 |
| Mid | 80 | 29.3 | 0.79 | 2.7 | |
| High | 80 | 59.8 | 2.70 | 4.5 |
1. A table of acceptance criteria and the reported device performance
See table above. As noted, the document doesn't explicitly state numerical acceptance criteria, but the presented data shows good correlation and low imprecision, which are typically the expected performance for analytical methods to demonstrate substantial equivalence.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size (Method Comparison): 50 samples for serum comparison, 50 samples for CSF comparison.
- Sample Size (Imprecision): 80 samples for each of the low, mid, and high concentration levels for both serum and CSF imprecision studies (this implies 80 measurements were performed repeatedly on a single sample at each level to derive the SD and CV, not 80 unique patient samples).
- Data Provenance: Not specified in the provided document. It is typical for such studies to be performed in a laboratory setting, often by the manufacturer or a contracted lab. The document does not indicate country of origin or whether the data was retrospective or prospective.
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 is an in vitro diagnostic (IVD) device for quantitative biochemical measurement, not an image-based diagnostic or clinical decision support system that would typically involve human experts for ground truth establishment.
- The "ground truth" for the method comparison study is the measurement obtained from the predicate device.
- For imprecision studies, the "ground truth" is the statistically derived mean value from repeated measurements.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. This is an analytical performance study of an IVD reagent, not judgmental interpretation by human readers requiring adjudication.
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 is an IVD reagent, not an AI-based diagnostic tool involving human readers or interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Yes, in a sense. The performance data presented (method comparison and imprecision) represents the "standalone" analytical performance of the IMMAGE system with the new reagents/calibrator, generating quantitative results. There is no human intervention in the result generation process itself, beyond operating the instrument and preparing samples.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Method Comparison: Measurements obtained from the legally marketed predicate device(s) were used as the reference or "ground truth" for comparison.
- Imprecision: The "ground truth" is based on the statistical mean of repeated measurements of samples at different concentration levels, indicating the inherent variability of the analytical method.
8. The sample size for the training set
- The document does not explicitly mention a "training set" in the context of machine learning. For IVD reagents, development involves extensive R&D, formulation, and validation. The data presented here is the performance data used for regulatory submission. The predicate device data is effectively the "reference" against which the new device's performance is tested.
9. How the ground truth for the training set was established
- Not applicable in the context of a machine learning "training set". If referring to the development of the assay itself, the ground truth would involve established reference methods for IgA measurement and thorough biochemical characterization to ensure the reagent accurately detects and quantifies IgA. However, the document provided does not detail the reagent development process. For the purpose of showing substantial equivalence, the performance of the predicate device acts as the established comparison "ground truth."
§ 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).