(137 days)
The IMMAGE Immunochemistry System Immunoglobulin G (IGG) reagent, when used in coniunction with Beckman IMMAGE™ Immunochemistry Systems and Beckman Calibrator 1, is intended for the quantitative determination of human immunoglobulin G by rate nephelometry.
The IMMAGE Immunochemistry System Immunoglobulin A (IGA) reagent, when used in conjunction with Beckman IMMAGE™ Immunochemistry Systems and Beckman Calibrator 1, is intended for the quantitative determination of human immunoglobulin A by rate nephelometry.
The IMMAGE Immunochemistry System Immunoglobulin M (IGM) reagent, when used in conjunction with Beckman IMMAGE™ Immunochemistry Systems and Beckman Calibrator 1. is intended for the quantitative determination of human immunoglobulin M by rate nephelometry.
The IMMAGE Immunochemistry System Immunoglobulins IGG, IGA, and IGM, Reagents in conjunction with Beckman Calibrator 1, are intended for use on Beckman's IMMAGE Immunochemistry System.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Beckman IMMAGE™ Immunochemistry System Immunoglobulins IGG, IGA, & IGM Reagents:
1. Table of Acceptance Criteria and Reported Device Performance
The document doesn't explicitly state "acceptance criteria" with numerical thresholds for performance metrics like slope, intercept, r, or %C.V. Instead, it presents the results of studies and implies that these results demonstrate "substantial equivalence to chemistry test systems already in commercial distribution."
However, based on the provided data, we can infer the reported performance, which implicitly functions as the evidence for meeting implied acceptance.
| Performance Metric | Acceptance Criteria (Implied) | Reported Device Performance (IMMAGE System vs. Predicate) |
|---|---|---|
| Method Comparison | Strong correlation and agreement with predicate device (high 'r', slope close to 1, intercept close to 0). | IGG Reagent (Serum): Slope = 1.037, Intercept = -16.6, r = 0.971 (n=323) IGG Reagent (CSF): Slope = 1.037, Intercept = 0.11, r = 0.985 (n=100) IGA Reagent (Serum): Slope = 1.031, Intercept = -2.07, r = 0.990 (n=289) IGM Reagent (Serum): Slope = 1.001, Intercept = -4.29, r = 0.998 (n=247) |
| Stability | Meeting stability claims (shelf-life, open container, calibration). | IMMAGE IGG, IGA, & IGM: - 24 month shelf-life - 14 day open container stability - 14 day calibration stability |
| Within-Run Imprecision | Low Coefficient of Variation (%C.V.) at different analyte levels. | IGG Reagent (Serum): Level 1: 549 mg/dL (mean), 10.8 mg/dL (SD), 2.0 %C.V. Level 2: 1293 mg/dL (mean), 203 mg/dL (SD) Level 3: 2362 mg/dL (mean), 51 mg/dL (SD) IGG Reagent (CSF): Level 1: 1.62 mg/dL (mean), 0.086 mg/dL (SD), 5.3 %C.V. Level 2: 7.85 mg/dL (mean), 0.104 mg/dL (SD), 1.3 %C.V. Level 3: 13.5 mg/dL (mean), 0.52 mg/dL (SD), 3.9 %C.V. (Incomplete data for IGA and IGM imprecision in the provided text, but the format implies similar data was used.) |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Sizes (Method Comparison):
- IMMAGE IGG (Serum): 323 samples
- IMMAGE IGG (CSF): 100 samples
- IMMAGE IGA (Serum): 289 samples
- IMMAGE IGM (Serum): 247 samples
- Sample Sizes (Imprecision):
- IGG (CSF) Levels: 30 samples for each of the 3 levels.
- The sample size for serum IGG imprecision is not explicitly stated as 'n' is missing from the table although it shows 3 levels of measurement.
- The sample sizes for IGA and IGM imprecision are not fully provided due to formatting issues in the input.
- Data Provenance: The document does not specify the country of origin of the data or whether the data was retrospective or prospective. It only mentions serum and CSF sample types.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This type of information (expert involvement for ground truth) is not applicable to this device. This is a quantitative diagnostic device that measures immunoglobulin levels. The "ground truth" is established by the performance of the predicate device (Beckman Immunochemistry Systems Reagents) and the inherent chemical/physical properties being measured. There are no human experts "interpreting" results for a ground truth in the way there would be for image-based diagnostic systems.
4. Adjudication Method for the Test Set
This is not applicable to this device. Adjudication methods (like 2+1, 3+1) are typically used for establishing ground truth in subjective assessments, such as expert interpretation of medical images. For a quantitative measurement device, the "ground truth" for comparison is the measurement obtained from the predicate device.
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 to this device. An MRMC study assesses human reader performance, often with and without AI assistance, particularly in areas like medical imaging. The IMMAGE system is a laboratory instrument for quantitative measurement, not a system intended to assist human "readers" in interpreting complex qualitative data.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
The entire performance study described is essentially a "standalone" or "algorithm only" performance for the IMMAGE system reagents. The device itself performs quantitative measurements without human intervention in the measurement process once the sample is loaded. The tables show the performance of the IMMAGE system's measurement compared to the predicate device's measurement.
7. The Type of Ground Truth Used
The "ground truth" in these studies is the measurement obtained from the predicate device (Beckman Immunochemistry Systems Immunoglobulin Reagents). The studies are designed to show that the new IMMAGE system provides results that are substantially equivalent to a legally marketed equivalent device. This is a form of comparative ground truth against an established, accepted diagnostic method.
8. The Sample Size for the Training Set
The document does not mention a "training set." This terminology is more common for machine learning or AI-based devices. For a conventional in-vitro diagnostic (IVD) device like this, there isn't a "training set" in the same sense. The device is developed and validated through chemical and instrument design, followed by performance studies (method comparison, stability, imprecision) using a series of collected samples.
9. How the Ground Truth for the Training Set Was Established
As there is no "training set" described in the context of this traditional IVD device, this question is not applicable. The underlying "ground truth" for the development of such reagents would be established through established analytical chemistry principles and assays used to characterize reference materials and calibrate the system.
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BECKMAN
Summary of Safety & Effectiveness IMMAGE™ Immunochemistry System Immunoglobulins IGG, IGA, & IGM Reagents
1.0 Submitted By:
K963868 FEB 10 1997
Annette Hellie Regulatory Specialist, Product Submissions Beckman Instruments, Inc. 200 S. Kraemer Blvd., W-337 Brea, California 92822-8000 Telephone: (714) 993-8767 FAX: (714) 961-4457
2.0 Date Submitted:
25 September-1996
Device Name(s): 3.0
3.1 Proprietary Names
IMMAGE™ Immunochemistry System Immunoglobulin G (IGG) Reagent IMMAGE™ Immunochemistry System Immunoglobulin A (IGA) Reagent IMMAGE™ Immunochemistry System Immunoglobulin M (IGM) Reagent
3.2 Classification Names
Immunoalobulin G Test System (21 CFR §866.5510) Immunoglobulin A Test System (21 CFR §866.5510) Immunoglobulin M Test System (21 CFR §866.5510)
4.0 Predicate Device(s):
| IMMAGE SystemReagent | Predicate | Manufacturer | DocketNumber |
|---|---|---|---|
| Immunoglobulin G(IGG) Reagent | ImmunochemistrySystemsImmunoglobulin GReagent | Beckman Instruments,Inc. | K771603 |
| Immunoglobulin A(IGA) Reagent | ImmunochemistrySystemsImmunoglobulin AReagent | Beckman Instruments,Inc. | K771603 |
| Immunoglobulin M(IGM) Reagent | ImmunochemistrySystemsImmunoglobulin MReagent | Beckman Instruments,Inc. | K771603 |
Beckman Instruments, Inc.
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Beckman Instruments, Inc., Section 510(k) Notification IMMAGE™ Immunochemistry System Immunoglobulins IGG, IGA, & IGM Reagents Summary of Safety & Effectiveness
5.0 Description:
The IMMAGE Immunochemistry System Immunoglobulins IGG, IGA, and IGM, Reagents in conjunction with Beckman Calibrator 1, are intended for use on Beckman's IMMAGE Immunochemistry System.
6.0 Intended Use:
The IMMAGE Immunochemistry System Immunoglobulin G (IGG) reagent, when used in coniunction with Beckman IMMAGE™ Immunochemistry Systems and Beckman Calibrator 1, is intended for the quantitative determination of human immunoglobulin G by rate nephelometry.
The IMMAGE Immunochemistry System Immunoglobulin A (IGA) reagent, when used in conjunction with Beckman IMMAGE™ Immunochemistry Systems and Beckman Calibrator 1, is intended for the quantitative determination of human immunoglobulin A by rate nephelometry.
The IMMAGE Immunochemistry System Immunoglobulin M (IGM) reagent, when used in conjunction with Beckman IMMAGE™ Immunochemistry Systems and Beckman Calibrator 1. is intended for the quantitative determination of human immunoglobulin M by rate nephelometry.
Comparison to Predicate(s): 7.0
The following table shows similarities and differences between the predicates identified in Section 4.0 of this summary.
| Reagent | Aspect/Characteristic:SIMILARITIES | Comments |
|---|---|---|
| IMMAGE System(IGG, IGA, & IGM)Reagents | Reagent antibody formulation | Same as ImmunochemistrySystems(IGG, IGA, & IGM) Reagents |
| Nephelometric rate methodology | ||
| Reagents are curve fit with thesame standards | ||
| DIFFERENCES | ||
| IMMAGE System(IGG, IGA, & IGM)Reagents | Antibody titer | Immunochemistry Systems(IGG, IGA, & IGM) reagentsuse a higher antibody titer. |
| IMMAGE System(IGG, IGA, & IGM)Reagents | Reaction Temperature | Immunochemistry Systemsoperate at 26°C, IMMAGESystem operates at 37°C |
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8.0 Summary of Performance Data:
The data in the Premarket Notification on safety and effectiveness supports a finding of substantial equivalence to chemistry test systems already in commercial distribution. Equivalence is demonstrated through method companson, stability, and imprecision experiments that results obtained from the Immunochemistry Systems Reagents to the IMMAGE System Reagents.
| Analyte | Sample Type | Slope | Intercept | r | n | Predicate Method |
|---|---|---|---|---|---|---|
| IMMAGEIGG Reagent | Serum | 1.037 | -16.6 | 0.971 | 323 | ImmunochemistrySystemsIGG Reagent |
| IMMAGEIGG Reagent | CSF | 1.037 | 0.11 | 0.985 | 100 | ImmunochemistrySystemsIGG Reagent |
| IMMAGEIGA Reagent | Serum | 1.031 | -2.07 | 0.990 | 289 | ImmunochemistrySystemsIGA Reagent |
| IMMAGEIGMReagent | Serum | 1.001 | -4.29 | 0.998 | 247 | ImmunochemistrySystemsIGM Reagent |
Method Comparison Study Results IMMAGE System IGG, IGA, & IGM Reagents
Stability Study Results
| Report | Product Claim |
|---|---|
| IMMAGE IGG, IGA, & IGM | 24 month shelf-life14 day open container stability14 day calibration stability |
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Estimated Within-Run Imprecision
| ART (R) | A Book Company Company Company Company Company Company Comments of Children Comments of Children Comments of Children Comments of Children Comments of Children Comments of Ch | a product to the comments of | ||
|---|---|---|---|---|
| Immunogiobulin G fiGG) (Serum sample, | ||||
| Level 1 | 549 | 10.8 | 2.0 | |
| Level 2 | 1293 | 203 | ||
| Level 3 | 2362 | 51 |
| Sample | Mean (mg/dL) | S.D. (mg/dL) | %C.V. | N |
|---|---|---|---|---|
| Immunoglobulin G (IGG) Reagent (CSF sample) | ||||
| Level 1 | 1.62 | 0.086 | 5.3 | 30 |
| Level 2 | 7.85 | 0.104 | 1.3 | 30 |
| Level 3 | 13.5 | 0.52 | 3.9 | 30 |
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|---|---|---|---|---|---|---|---|
| Immunoalobulin A (IGA) Reagent | |||||||
| evel | |||||||
| Level 7 | 400 | ||||||
| evel 3 |
| tean (mg/dL) .100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 -AND THE CALL CALL CALL PORTER FOR THE FORCarlo Concession | |||||||
|---|---|---|---|---|---|---|---|
| Immunoglobulin M (IGM) Re | |||||||
| eve | |||||||
| evel K | 0.6 |
This summary of safety and effectiveness is being submitted in accordance with the This Summary of Safe Medical Device Act of 1990 and the implementing regulation 21 CFR 807.92.
§ 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).