(477 days)
For the qualitative, semi-quantitative and quantitative detection of IgG antibodies to rubella in human serum by indirect enzyme immunoassay to aid in the assessment of the patient's immunological response to rubella and in the determination of the immune status of individuals, including females of child-bearing age. The evaluation of acute and convalescent sera can aid in the diagnosis of current or recent infection with rubella.
The Mago 4S Automated EIA and IFA Processor is a pipetting, diluting, incubating, and color intensity analyzing system for in vitro diagnostic clinical use for the processing of FDA-cleared enzyme-linked immunoabsorbent assays (EIA) through result generation. In addition, it processes immunofluorescence assay (IFA) slides for off-platform detection and result generation.
The MAGO 4S is an automated laboratory instrument designed to automate the processing of enzyme-linked immunoabsorbent assays (EIA) as well as Immunofluorescence Assay (IFA) slides. The MAGO 4S is designed to minimize manual operations associated with performing routine laboratory analysis by mechanizing and computerizing the test process.
The provided document describes the MAGO 4S, an automated laboratory instrument for processing enzyme-linked immunoabsorbent assays (EIA) and immunofluorescence assay (IFA) slides, specifically for the detection of IgG antibodies to rubella in human serum. The study aims to demonstrate substantial equivalence to predicate devices.
Here's an analysis of the acceptance criteria and study data:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state pre-defined acceptance criteria in terms of specific thresholds for precision, linearity, or agreement percentages before the study was conducted. Instead, it presents the results obtained and implies that these results are deemed acceptable for substantial equivalence. For the purpose of this table, I will infer the acceptance from the presented "Pass" results and the general expectation for such assays.
| Performance Metric | Acceptance Criteria (Inferred from "Pass") | Reported Device Performance |
|---|---|---|
| Precision/Reproducibility | Comparable results with manual testing; 3 standard deviations of all data for each sample < 3.0 IU/ml (for reproducibility). | Achieved for both precision and reproducibility. See detailed CV% tables by site and QC sample. For reproducibility, 3 SD < 3.0 IU/ml. |
| Linearity/Reportable Range | R-squared (R²) of the regression line should demonstrate good linearity. | R² = 0.974. |
| Positive Percent Agreement (Equivocal Zone) | High positive agreement with manual method (near equivocal range). | 94.44% |
| Negative Percent Agreement (Equivocal Zone) | High negative agreement with manual method (near equivocal range). | 100.00% |
| CDC Performance Panel | All criteria set by the CDC must be met. | All CDC criteria passed (18 Neg / 82 Pos, only 2 bad ratios for reproducibility, no major deviations in correlation of DMX titer). |
| CDC Biological Standard | Results should be within a defined range (Target ± 10%) for various dilutions. | Results were within the target range (Target ± 10%). |
2. Sample Size and Data Provenance
- Test Set Sample Sizes:
- Precision/Reproducibility: 6 well-characterized samples (Diamedix QC Panels) for precision. 3 positive normal samples diluted to ~10 IU/ml for reproducibility. Run over 20 days, 2 runs per day, suggesting a significant number of replicates (e.g., if each 'Run' has multiple measurements, then (12 runs/day * 20 days * # replicates per run) for precision, and 3 samples * 20 days * 2 runs per day for reproducibility).
- Linearity/Reportable Range: Strong positive and weak positive samples diluted seven times at evenly spaced intervals.
- Positive and Negative Agreement with Comparator and Assessment of Equivocal Zone: Approximately 100 samples in <10 IU/ml, 50 samples in 10-20 IU/ml, and 50 samples in >20 IU/ml range. A total of 208 sera were tested. An additional ~20 patient samples were used for the equivocal zone assessment.
- CDC Performance Panel: 100 sera provided by the CDC.
- CDC Biological Standard: CDC Biological Standard, Low-Titer Anti Rubella Human Reference Serum, used with a dilution series.
- Data Provenance: Not explicitly stated whether retrospective or prospective. Given the nature of performance testing for a new device, it is likely prospective, with samples collected or acquired specifically for this study. The country of origin for general samples is not mentioned, but the CDC performance panel samples are from the US.
3. Number of Experts and Qualifications for Ground Truth
- The document does not mention the use of external human experts to establish ground truth for the test set that directly compares the MAGO 4S to a reference.
- For the "Positive and Negative Agreement with Comparator" test, the "manual" method acts as the comparative standard. The expertise for establishing the results of the manual method would rely on the laboratory personnel performing those tests, presumably qualified medical technologists or similar professionals.
- For the CDC Performance Panel, the "CDC Target" is used as the ground truth. This implicitly relies on the expertise and established reference methods of the CDC.
4. Adjudication Method
- The document does not describe a formal adjudication method (like 2+1 or 3+1) involving multiple human readers/reviewers for the test set.
- For the "Positive and Negative Agreement with Comparator," it seems a single manual test result was compared to a single MAGO 4S result for each sample. Equivocal results were specifically addressed in a retest zone assessment.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No MRMC comparative effectiveness study was done. This study focuses on the performance of the automated instrument itself (standalone performance) against manual methods or established standards, not on the improvement of human readers with AI assistance.
6. Standalone Performance Study
- Yes, a standalone performance study was done. The entire submission details the performance of the MAGO 4S automated instrument (algorithm only, without human-in-the-loop performance) in various aspects such as precision, linearity, and agreement with established methods/standards.
7. Type of Ground Truth Used
- Existing Legally Marketed Devices/Manual Methods: For precision, linearity, and positive/negative agreement, the "Diamedix test kit" (manual method) serves as the comparator, and its results are implicitly considered ground truth for comparison.
- Reference Standards/Panels:
- CDC Performance Panel: The "CDC Target" results for the 100 sera served as the external ground truth.
- CDC Biological Standard: The expected IU/ml values for the various dilutions of the Low-Titer Anti Rubella Human Reference Serum served as the reference ground truth.
8. Sample Size for the Training Set
- The document does not provide information on a specific "training set" or sample sizes used for training the MAGO 4S in the context of machine learning or AI. This device appears to be an automated instrument following predefined protocols for assays (EIA/IFA) rather than a system requiring extensive machine learning model training on large datasets in the way modern AI devices do. Its "development" would involve engineering and calibration rather than algorithm training on a separate dataset.
9. How the Ground Truth for the Training Set was Established
- As noted in point 8, the document does not describe a "training set" in the context of machine learning. Therefore, methods for establishing ground truth for such a set are not applicable or described within this submission. The "ground truth" for the device's operational parameters would have been established during its engineering, calibration, and internal validation processes based on reference materials and established assay principles.
{0}------------------------------------------------
JAN 2 1 2011
2. 510(k) Summary
This 510(k) summary information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
| APPLICANT: | Diamedix Corporation |
|---|---|
| TRADE NAME: | MAGO 4S |
| COMMON NAME: | MicroChemistry Analyzer |
| CLASSIFICATION NAME: | Micro Chemistry Analyzer for Clinical Use |
| DEVICECLASSIFICATION: | Class II, 866.3510 (Rubella virus serological reagents) |
| PRODUCT CODE: | LFX (Enzyme Linked Immunoabsorbent Assay, Rubella)JJF |
| PANEL: | Virology (81) |
| PREDICATE DEVICES: | PhD System, Bio-Rad Laboratories (Class I, 510(k) exempt |
- Note: The instrument performance assessment in this submission is based on both the performance data in the original Rubella submission (K981729) and the requested data described in the performance section below.
Description of the Device Subject to Premarket Notification:
The MAGO 4S is an automated laboratory instrument designed to automate the processing of enzyme-linked immunoabsorbent assays (EIA) as well as Immunofluorescence Assay (IFA) slides. The MAGO 4S is designed to minimize manual operations associated with performing routine laboratory analysis by mechanizing and computerizing the test process.
Intended Use:
For the qualitative, semi-quantitative and quantitative detection of IgG antibodies to rubella in human serum by indirect enzyme immunoassay to aid in the assessment of the patient's immunological response to rubella and in the determination of the immune status of individuals, including females of child-bearing age. The evaluation of acute and convalescent sera can aid in the diagnosis of current or recent infection with rubella.
The Mago 4S Automated EIA and IFA Processor is a pipetting, diluting, incubating, and color intensity analyzing system for in vitro diagnostic clinical use for the processing of FDA-cleared enzyme-linked immunoabsorbent assays (EIA) through result generation. In addition, it processes immunofluorescence assay (IFA) slides for off-platform detection and result generation.
{1}------------------------------------------------
Technical Characteristics:
The MAGO 4S Automated EIA and IFA Processor has similar physical and technical characteristics to the predicate device.
Basis for Determination of Substantial Equivalence:
Upon reviewing the information provided in this submission and comparing intended use, principle of operation and overall technological characteristics, the MAGO 4S Automated EIA and IFA Processor is determined by Diamedix, to be substantially equivalent to existing legally marketed devices.
Performance Data:
All necessary verification and validation testing has been performed for the MAGO 4S Automated EIA and IFA Processor to assure substantial equivalence to the predicate devices. Specifically the following tests were performed with Rubella IgG: Precision/ Reproducibility, Linearity/Reportable range (where the strong positive and weak positive samples were diluted seven times at evenly spaced intervals), Positive and Negative Agreement with Comparator and Assessment of Equivocal Zone, CDC Performance Panel, and the CDC Biological Standard.
-
- Precision/Reproducibility: For Precision, there were 6 well characterized samples (Diamedix QC Panels) run; two were negative and the other four spanned the reportable range of the Diamedix test kit. Comparable results were obtained from testing these samples manually versus testing them on the MAGO 4S. For reproducibility, three positive normal samples were selected and diluted to adjust their value to be near 10 IU/ml (slightly positive), per the CLSI standard. Test results showed that 3 standard deviations of all data for each sample was < 3.0 IU/ml. See the tables on the following pages.
{2}------------------------------------------------
| Site 1 PrecisionIntra AssayCV % | Day | QC ARun 1 | QC ARun 2 | QC BRun 1 | QC BRun 2 | QC CRun 1 | QC CRun 2 | QC DRun 1 | QC DRun 2 | QC ERun 1 | QC ERun 2 | QC FRun 1 | QC FRun 2 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | 47.14% | 0.00% | 20.20% | 17.68% | 0.74% | 0.74% | 0.52% | 4.32% | 0.44% | 4.00% | 0.29% | ||
| 2 | 23.57% | 15.71% | 10.88% | 10.88% | 0.70% | 7.78% | 1.50% | 5.15% | 9.21% | 5.08% | 0.00% | 3.78% | |
| 3 | 20.20% | 15.71% | 10.88% | 17.68% | 0.34% | 0.28% | 0.49% | 1.59% | 2.36% | 5.31% | 8.48% | ||
| 4 | 0.00% | 0.00% | 20.20% | 28.28% | 3.45% | 3.95% | 4.49% | 2.48% | 7.44% | 11.80% | 2.58% | ||
| 5 | 0.00% | 28.28% | 10.88% | 20.20% | 8.60% | 2.63% | 6.46% | 0.74% | 3.50% | 9.07% | 1.45% | ||
| 6 | 12.86% | 0.00% | 9.43% | 28.28% | 2.08% | 6.30% | 3.60% | 4.67% | 0.63% | 4.63% | 5.50% | ||
| 7 | 7.44% | 0.00% | 28.28% | 47.14% | 8.06% | 2.55% | 12.62% | 4.51% | 3.52% | 2.47% | 0.58% | ||
| 8 | 12.86% | 10.88% | 0.00% | 15.71% | 0.70% | 18.00% | 12.20% | 8.19% | 1.13% | 3.25% | 5.95% | 3.87% | |
| 9 | 20.20% | 23.57% | 0.00% | 10.88% | 1.76% | 8.73% | 11.76% | 6.35% | 4.73% | 9.52% | 1.02% | 4.30% | |
| 10 | 8.32% | 15.71% | 28.28% | 38.57% | 2.27% | 0.60% | 11.15% | 2.52% | 3.34% | 3.79% | 2.67% | ||
| 11 | 28.28% | 47.14% | 35.36% | 20.20% | 2.12% | 2.97% | 6.71% | 8.20% | 1.15% | 0.66% | 3.45% | ||
| 12 | 15.71% | 15.71% | 40.41% | 32.64% | 2.32% | 1.08% | 9.28% | 10.26% | 3.83% | 0.38% | |||
| 13 | 10.88% | 8.32% | 28.28% | 10.88% | 3.31% | 5.13% | 0.62% | 10.41% | 4.93% | 3.81% | |||
| 14 | 8.32% | 9.43% | 66.00% | 23.57% | 3.17% | 2.02% | 4.73% | 3.43% | 3.48% | 3.03% | |||
| 15 | 32.64% | 7.44% | 35.36% | 15.71% | 1.21% | 2.34% | 2.23% | 4.16% | 1.80% | 0.64% | |||
| 16 | 14.14% | 10.88% | 38.57% | 23.57% | 11.67% | 6.69% | 0.40% | 14.36% | 7.07% | 10.88% | |||
| 17 | 7.44% | 0.00% | 32.64% | 12.86% | 10.88% | 8.55% | 5.14% | 0.47% | 5.42% | 1.46% | 1.15% | 4.19% | |
| 18 | 0.00% | 9.43% | 9.43% | 23.57% | 0.63% | 2.18% | 4.70% | 4.19% | 6.42% | 9.58% | |||
| 19 | 32.64% | 17.68% | 0.00% | 38.57% | 3.01% | 1.82% | 11.90% | 7.20% | 5.47% | 12.50% | 3.63% | ||
| 20 | 0.00% | 9.43% | 0.00% | 94.28% | 0.71% | 0.34% | 2.26% | 8.94% | 0.22% | 0.00% | 0.45% | 2.35% | |
| InterassayMean | 0.668 | 0.624 | 22.853 | 30.308 | 35.104 | 47.649 | |||||||
| InterassaySD | 0.230 | 0.189 | 3.423 | 3.799 | 3.881 | 1.945 | |||||||
| InterassayCV% | 34.52% | 30.32% | 14.98% | 12.54% | 11.06% | 4.08% |
Note:
Note:
Readings for QC F that were reported as >200 are shown as blanks, no statistics were possible. When low results are reported on an analyte, a high coefficient of variation (CV) may result. (Taken from CAP survey)
| Site 2 PrecisionIntra AssayCV % | Day | QC ARun 1 | QC ARun 2 | QC BRun 1 | QC BRun 2 | QC CRun 1 | QC CRun 2 | QC DRun 1 | QC DRun 2 | QC ERun 1 | QC ERun 2 | QC FRun 1 | QC FRun 2 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | 35.36% | 40.41% | 0.00% | 60.61% | 4.54% | 5.33% | 3.60% | 6.04% | 2.82% | 2.74% | 1.17% | ||
| 2 | 30.74% | 22.33% | 25.71% | 60.61% | 3.63% | 8.67% | 12.99% | 6.61% | 0.80% | 1.60% | 5.43% | ||
| 3 | 18.45% | 62.85% | 28.28% | 25.71% | 4.40% | 3.11% | 5.74% | 5.13% | 0.38% | 6.03% | 2.90% | 1.01% | |
| 4 | 18.45% | 28.28% | 26.19% | 22.33% | 5.01% | 8.07% | 9.12% | 8.47% | 0.84% | 4.51% | |||
| 5 | 22.33% | 28.28% | 28.28% | 37.22% | 13.42% | 11.45% | 9.90% | 5.94% | 4.49% | 0.54% | 1.88% | ||
| 6 | 35.36% | 32.64% | 106.07% | 10.88% | 3.45% | 1.98% | 9.76% | 7.68% | 2.47% | 1.46% | |||
| 7 | 20.20% | 31.43% | 17.68% | 54.39% | 8.55% | 2.18% | 6.38% | 6.11% | 0.39% | 5.45% | 0.87% | 1.52% | |
| 8 | 20.20% | 42.43% | 23.57% | 47.14% | 6.76% | 3.37% | 12.82% | 3.35% | 3.55% | 1.13% | |||
| 9 | 31.43% | 33.67% | 31.43% | 30.74% | 2.95% | 3.21% | 3.40% | 10.17% | 0.00% | 2.23% | |||
| 10 | 23.57% | 25.71% | 20.20% | 31.43% | 6.04% | 0.47% | 7.24% | 10.24% | 2.11% | ||||
| 11 | 30.74% | 28.28% | 43.89% | 23.57% | 1.39% | 4.96% | 5.24% | 6.31% | 1.37% | 3.33% | |||
| 12 | 30.74% | 43.51% | 21.76% | 32.64% | 7.58% | 9.24% | 23.13% | 6.34% | 2.05% | ||||
| 13 | 47.14% | 18.45% | 41.59% | 58.23% | 9.19% | 8.79% | 4.30% | 11.74% | 6.45% | 0.68% | 2.00% | 2.23% | |
| 14 | 30.74% | 38.57% | 35.36% | 56.57% | 6.07% | 1.36% | 5.39% | 7.84% | 1.10% | 3.07% | 0.00% | ||
| 15 | 18.45% | 37.22% | 20.20% | 41.59% | 0.00% | 2.50% | 13.83% | 8.07% | 2.29% | 2.80% | |||
| 16 | 23.57% | 14.14% | 47.14% | 37.22% | 6.50% | 0.60% | 2.93% | 4.64% | 6.22% | 8.06% | 0.00% | ||
| 17 | 16.97% | 33.67% | 28.28% | 42.43% | 1.59% | 6.19% | 2.54% | 4.50% | 0.90% | 6.91% | |||
| 18 | 30.74% | 35.36% | 47.14% | 64.28% | 5.19% | 14.18% | 5.10% | 1.68% | 1.70% | 2.53% | 2.33% | ||
| 19 | 10.88% | 51.43% | 47.14% | 47.14% | 14.52% | 3.50% | 6.98% | 4.17% | 1.53% | 1.67% | 0.16% | ||
| 20 | 28.28% | 16.97% | 28.28% | 0.00% | 5.19% | 9.95% | 0.80% | 2.72% | 1.10% | 3.47% | 0.16% | 0.15% | |
| InterassayMean | 1.026 | 0.901 | 25.375 | 31.545 | 37.799 | 47.692 | |||||||
| InterassaySD | 0.288 | 0.358 | 4.845 | 5.040 | 5.476 | 1.628 | |||||||
| InterassayCV% | 28.11% | 39.69% | 19.09% | 15.98% | 14.49% | 3.41% |
Readings for QC F that were reported as >200 are shown as blanks, no statistics were possible.
Readings for QC F that were reported as 2200 are showled to belief. In other from CAP survey)
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| Site 3 Precision | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Intra AssayCV % | Day | QC ARun 1 | QC ARun 2 | QC BRun 1 | QC BRun 2 | QC CRun 1 | QC CRun 2 | QC DRun 1 | QC DRun 2 | QC ERun 1 | QC ERun 2 | QC FRun 1 | QC FRun 2 | |
| 1 | 0.00% | 41.59% | 47.14% | 20.20% | 21.49% | 14.63% | 0.23% | 3.13% | 5.19% | 4.81% | 2.42% | |||
| 2 | 31.43% | 47.14% | 28.28% | 35.36% | 0.66% | 7.99% | 1.58% | 4.81% | 1.27% | 1.04% | ||||
| 3 | 53.03% | 35.36% | 41.59% | 28.28% | 14.59% | 0.31% | 2.08% | 4.89% | 2.63% | 3.21% | ||||
| 4 | 35.36% | 41.59% | 35.36% | 35.36% | 11.24% | 3.86% | 2.59% | 0.92% | 1.00% | 0.79% | ||||
| 5 | 30.74% | 42.43% | 37.22% | 31.43% | 4.07% | 2.85% | 8.86% | 8.21% | 1.78% | 0.65% | ||||
| 6 | 40.41% | 31.43% | 8.32% | 31.43% | 17.65% | 5.26% | 18.06% | 4.93% | 0.94% | |||||
| 7 | 23.57% | 25.71% | 3.01% | 29.86% | 0.00% | |||||||||
| 8 | 35.36% | 51.43% | 38.57% | 47.14% | 8.12% | 1.38% | 9.91% | 13.65% | 8.35% | 4.16% | 2.46% | |||
| 9 | 6.15% | 28.28% | 64.28% | 42.43% | 12.75% | 11.93% | 6.04% | 7.35% | 5.61% | 3.23% | ||||
| 10 | 42.43% | 30.30% | 37.22% | 42.43% | 5.22% | 3.46% | 4.09% | 6.19% | 6.36% | 0.40% | ||||
| 11 | 38.57% | 28.28% | 53.03% | 47.14% | 0.00% | 2.24% | 3.88% | 4.74% | 1.26% | 5.17% | ||||
| 12 | 64.28% | 30.74% | 42.43% | 37.22% | 4.99% | 0.51% | 3.84% | 1.94% | 0.17% | 1.05% | ||||
| 13 | 24.38% | 32.64% | 66.99% | 33.67% | 1.09% | 2.89% | 3.59% | 6.10% | 2.58% | 1.54% | ||||
| 14 | 41.59% | 47.14% | 31.43% | 28.28% | 1.86% | 8.04% | 11.88% | 3.61% | 7.79% | 1.54% | ||||
| 15 | 38.57% | 40.41% | 47.14% | 41.59% | 0.98% | 3.87% | 7.34% | 8.32% | 3.93% | 1.13% | ||||
| 16 | 37.22% | 37.22% | 52.10% | 47.14% | 24.87% | 6.56% | 7.44% | 5.05% | 2.56% | 5.78% | ||||
| 17 | 47.14% | 66.00% | 22.33% | 54.39% | 8.13% | 15.41% | 3.26% | 2.28% | 0.20% | 0.69% | ||||
| 18 | 47.14% | 37.22% | 28.28% | 35.36% | 0.56% | 0.81% | 8.15% | 11.26% | 3.36% | 6.09% | ||||
| 19 | 30.00% | 32.64% | 6.15% | 33.67% | 7.44% | 2.89% | 14.22% | 6.10% | 12.41% | 1.54% | ||||
| 20 | 40.41% | 41.59% | 0.00% | 47.14% | 8.94% | 1.50% | 5.77% | 6.51% | 2.38% | 6.15% | 6.59% | |||
| InterassayMean | 1.036 | 0.877 | 25.086 | 32.538 | 36.863 | 46.964 | ||||||||
| InterassaySD | 0.368 | 0.276 | 3.970 | 5.013 | 4.365 | 1.527 | ||||||||
| InterassayCV% | 35.54% | 31.45% | 15.83% | 15.41% | 11.84% | 3.25% | ||||||||
| Note: | Readings for QC F that were reported as >200 are shown as blanks, no statistics were possible. | |||||||||||||
| When low results are reported on an analyte, a high coefficient of variation (CV) may result. (Taken from CAP survey) |
100 Children Children
. . . . . . . .
{4}------------------------------------------------
-
- Linearity/Reportable range: the strong positive and weak positive samples were diluted seven times at evenly spaced intervals. The R2 of the regression line came out to be 0.974. See data below and the next page.
| Mago 4S Linearity StudyRUBELLA Single Pt | Site - DMX | |||
|---|---|---|---|---|
| Mean | Expected | |||
| Name | M4S Conc. | Mean | ordered | Conc. |
| RUBLOW | 0 | 0.05 | 0.05 | 0.05 |
| A-02 | 0.1 | 1.15 | 0.6474 | |
| .417L/.083H | 1.3 | 1.15 | 1.85 | 1.2948 |
| A-04 | 1 | 2.15 | 1.95 | |
| .334L/.166H | 2 | 1.85 | 2.9 | 2.6052 |
| A-06 | 1.7 | 3.65 | 3.2526 | |
| .25L/.25H | 2.1 | 2.15 | 3.9 | 3.9 |
| A-08 | 2.2 | |||
| .166L/.334H | 2.7 | 2.9 | ||
| A-10 | 3.1 | |||
| .083L/.417H | 3.6 | 3.65 | ||
| A-12 | 3.7 | |||
| RUBHIGH | 4.1 | 3.9 | ||
| A-14 | 3.7 |
{5}------------------------------------------------
Image /page/5/Figure/0 description: The image is a graph titled "Linearity RUBELLA Single Point". The graph shows the relationship between the M4S Value and the Expected Conc. There are several data points plotted on the graph, and a line of best fit is drawn through the points. The equation of the line is y = 1.0017x - 0.2823, and the R-squared value is 0.9741.
-
- Positive and Negative Agreement with Comparator and Assessment of Equivocal Zone:
For Sensitivity and Specificity, approximately 100 samples in,the <10 IU/ml range, 50 samples in the 10-20 IU/ml range, and 50 samples in the >20 IU/ml range were assayed. A total of two hundred and eight sera were tested once manually and once on the Mago 4S. The breakdown of Positive, Negative, and Equivocal results are seen in the Table below.
- Positive and Negative Agreement with Comparator and Assessment of Equivocal Zone:
| Mago 4SManual | Positive | Negative | *Equivocal | Total |
|---|---|---|---|---|
| Positive | 98 | 0 | 2 | 100 |
| Negative | 2 | 80 | 3 | 85 |
| *Equivocal | 10 | 1 | 12 | 23 |
| Total | 110 | 81 | 17 | 208 |
| Comparison of Oualitative Results of Manual versus Mago 4S | ||||||
|---|---|---|---|---|---|---|
| ------------------------------------------------------------ | -- | -- | -- | -- | -- | -- |
- Equivocal results are excluded from calculations.
An assessment of Equivocal Zone was subsequently performed, and each kit was tested on the MAGO 4S and manually against the approximately 20 patient samples which were earlier identified in a retest zone (having originally tested manually between 7 and 13 IU/ml). The results showed that there was a single sample mean that indicated positive (≥ 10 IU/ml) on the manual test and indicated < 10 IU/ml on the Mago 4S. All the <10 IU/ml individual results fall within the product's equivocal range of 8 to < 10 IU/ml, which would cause a retest. See the Table on the next page.
{6}------------------------------------------------
| Predicate (manual) | ||||
|---|---|---|---|---|
| ≥10(+) | <10 | Total | ||
| NewTest(Mago4S) | ≥10 | 17 | 0 | 17 |
| <10 | 1 | 2 | 3 | |
| Total | 18 | 2 | 20 |
Comparison of Mago vs. Manual for samples near equivocal range
| Positive PercentAgreement | 94.44% |
|---|---|
| Negative PercentAgreement | 100.00% |
-
- CDC Performance Panel results: a total of 100 sera provided by the CDC were tested for the presence of rubella IgG antibodies on the MAGO 4S. The subsequent data was sent to the CDC for evaluation, and all of the results passed. See the Table below.
| CDC Criteria | CDC Target | Results | Pass / Fail |
|---|---|---|---|
| Determination of Positiveand Negative Sera | 18 Neg / 82 Pos | 18 Neg / 82 Pos | PASS |
| Reproducibility of resultsfrom paired sera | 5 – 10 sera pairs with"bad ratios" (>1.25)(typical results) | Only 2 sera pairswith bad ratios; 39sera pairs with"good ratios;" also,all 18 results from 9negative sera pairswere negative | PASS |
| Correlation of DMX titerwith HI titer of paired sera | No Major Deviationsfrom continuously.increasing signals forsera pairs | No Major Deviationsfrom continuouslyincreasing signalsfor sera pairs | PASS |
Summary of Evaluation of MAGO 4S Results of CDC Rubella serum panel
-
- CDC Biological Standard results: CDC Biological Standard, Low-Titer Anti Rubella Human Reference Serum, was used to verify the Diamedix Rubella IgG assay cutoff. This standard contains 21.0 IU/ml of Rubella IgG antibody. A dilution series was performed starting with a 1:2 dilution. The expected value for the 1:2 dilution of the CDC standard is 10 to 15 IU/ml, which is in agreement with the CDC immunity cutoff reference level. The results were within range as shown on the Table below and on the next page.
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| Low Titer CDC Control | ||||
|---|---|---|---|---|
| -- | -- | -- | ----------------------- | -- |
| OD | IU/ml | Result | Target | Target -10% | Target+10% | |
|---|---|---|---|---|---|---|
| CDC 1:8 | 0.286 | 4.6 | Neg | |||
| CDC 1:8 Rep | 0.277 | 4.4 | Neg | 3.625 | 3.2625 | 3.9875 |
| CDC 1:4 | 0.424 | 7.3 | Equiv | |||
| CDC 1:4 Rep | 0.443 | 7.7 | Equiv | 7.25 | 6.525 | 7.975 |
| CDC 1:2 | 0.707 | 14.4 | Pos | |||
| CDC 1:2 Rep | 0.69 | 13.9 | Pos | 14.05 | 12.645 | 15.455 |
| CDC | 0.951 | 24.8 | ||||
| CDC Rep | 1.033 | 31.4 | 28.1 | 25.29 | 30.92 |
Image /page/7/Figure/2 description: The image is a graph titled "CDC Low Titer Dilution Series". The x-axis is labeled "Result IU/ml" and ranges from 0 to 35. The y-axis is labeled "Target" and ranges from 0 to 30. The graph plots a series of data points labeled "Series1" and includes a linear trendline with the equation y = 0.8949x + 0.4145 and an R-squared value of 0.9939.
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Image /page/8/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is a stylized symbol that resembles a caduceus, a traditional symbol of medicine, but with a more abstract and modern design. The symbol features a winding, ribbon-like shape that could be interpreted as a serpent or a staff.
Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993
Diamedix Corp. c/o Glenn Gerstenfeld Director of Quality Assurance Regulatory Affairs 2140 N. Miami Avenue Miami, FL 33127
JAN 2 1 - 2011
Re: K093101
| Trade/Device Name: | MAGO 4S |
|---|---|
| Regulation Number: | 21 CFR §866.3510 |
| Regulation Name: | Rubella virus serological reagents |
| Regulatory Class: | Class II |
| Product Code: | LFX, JJF |
| Dated: | December 1, 2010 |
| Received: | December 2, 2010 |
Dear Mr. Gerstenfeld:
We have reviewed your Section 510/k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.lda.gov/AboutFDA/CentersOffices/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDeyices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Vouy a Hogn
Sally A. Hoivat. M.S. Director Division of Microbiology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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INDICATIONS FOR USE STATEMENT
510(k) Number (if known): K093101 Device Name: Indications for Use:
For the qualitative, semi-quantitative and quantitative detection of IgG antibodies to rubella in human serum by indirect enzyme immunoassay to aid in the assessment of the patient's immunological response to rubella and in the determination of the immune status of individuals, including females of child-bearing age. The evaluation of acute and convalescent sera can aid in the diagnosis of current or recent infection with rubella.
The Mago 4S Automated EIA and IFA Processor is a pipetting, diluting, incubating, and color intensity analyzing system for in vitro diagnostic clinical use for the processing of FDA-cleared enzyme-linked immunoabsorbent assays (EIA) through result generation. In addition, it processes immunofluorescence assay (IFA) slides for off-platform detection and result generation.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics Devices (OIVD)
| X | Division Sign-Off |
|---|
| Prescription Use (Per 21 CFR 801. subpart D) | Office of In Vitro Diagnostic Device-Counter Use (Per 21 CFR 801. subpart C) |
|---|---|
| Evaluation and Safety |
510(k)________________________________________________________________________________________________________________________________________________________________________
§ 866.3510 Rubella virus serological reagents.
(a)
Identification. Rubella virus serological reagents are devices that consist of antigens and antisera used in serological tests to identify antibodies to rubella virus in serum. The identification aids in the diagnosis of rubella (German measles) or confirmation of a person's immune status from past infections or immunizations and provides epidemiological information on German measles. Newborns infected in the uterus with rubella virus may be born with multiple congenital defects (rubella syndrome).(b)
Classification. Class II. The special controls for this device are:(1) National Committee for Clinical Laboratory Standards':
(i) 1/LA6 “Detection and Quantitation of Rubella IgG Antibody: Evaluation and Performance Criteria for Multiple Component Test Products, Speciment Handling, and Use of the Test Products in the Clinical Laboratory, October 1997,”
(ii) 1/LA18 “Specifications for Immunological Testing for Infectious Diseases, December 1994,”
(iii) D13 “Agglutination Characteristics, Methodology, Limitations, and Clinical Validation, October 1993,”
(iv) EP5 “Evaluation of Precision Performance of Clinical Chemistry Devices, February 1999,” and
(v) EP10 “Preliminary Evaluation of the Linearity of Quantitive Clinical Laboratory Methods, May 1998,”
(2) Centers for Disease Control's:
(i) Low Titer Rubella Standard,
(ii) Reference Panel of Well Characterized Rubella Sera, and
(3) World Health Organization's International Rubella Standard.