(46 days)
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No
The summary describes a standard ELISA test kit and an automated processor, neither of which are described as using AI or ML. The performance studies are based on traditional statistical analysis of assay results.
No.
This device is an in vitro diagnostic (IVD) test kit used for semi-quantitative measurement of antibodies as an aid in diagnosis, not for direct therapeutic intervention.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "as an aid in the diagnosis of certain autoimmune disease thrombotic disorders".
No
The device description explicitly states it is an enzyme-linked immunosorbent assay (ELISA) and mentions its use with a MAGO® Plus Automated EIA Processor, indicating it is a hardware-based test kit with an optional automated processor, not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states that the device is for the "semi-quantitative measurement of IgG or IgM antibodies to ßglycoprotein I in human serum as an aid in the diagnosis of certain autoimmune disease thrombotic disorders". This clearly indicates that the device is intended to be used in vitro (outside the body) to examine specimens (human serum) for diagnostic purposes.
- Device Description: The "Device Description" further clarifies that it is an "enzyme-linked immunosorbent assay (ELISA) for the semi-quantitative measurement of IgG or IgM antibodies to ß, glycoprotein in human serum". ELISA is a common laboratory technique used for in vitro diagnostic testing.
- Performance Studies: The document details various performance studies conducted on the device using human serum samples, which is typical for IVD devices.
- Key Metrics: The inclusion of metrics like Sensitivity and Specificity are standard performance indicators for IVD devices.
- Predicate Device(s): The mention of "Predicate Device(s)" with names like "QUANTA Lite ß,GPI IgG & QUANTA Lite ß,GPI IgM" further confirms that this device is being compared to other existing IVD devices in the market.
All these points strongly indicate that the Diamedix Is anti-β ,Glycoprotein | IgG/IgM Test Kit is an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The assay is intended for the semi-quantitative measurement of IgG or IgM antibodies to B, glycoprotein I in human serum. The results of the assay can be used as an aid in the diagnosis of certain autoimmune disease thrombotic disorders in patients with SLE or SLE-like dosorders.
Product codes
MSV
Device Description
The Is anti-ß, Glycoprotein I IgG/IgM Test System is an enzyme-linked immunosorbent assay (ELISA) for the semi-quantitative measurement of IgG or IgM antibodies to ß, glycoprotein in human serum
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
A. 3-point vs 6-point calibration
To demonstrate the equivalence of both calibration methods, the results of 178 samples tested using the Is-anti-B, Glycoprotein I IgG and 187 samples tested using the Is-anti-B,Glycoprotein I IgM, calculated using either the 3-point Or 6-point calibration systems, were subjected to linear regression analysis. Scattergrams and regression lines of the of of obtained with 95% confidence intervals are shown in FIGURES 1 and 2. Also included are the regression statistics.
B. Relative Sensitivity and Specificity
One hundred and seventy-two frozen retrospective sera were tested for IgG antibodies and one hundred and sixty-one One numeros and so very on e ested for IgM antibodies using the Is-anti-B. -Glycoprotein I IgG/IgM Test Kit and commercially available ELISA kits for detecting IgG and IgM B - glycoprotein I antibodies. Based on the results of this testing the relative sensitivity, relative specificity and overall agreement were calculated. The results obtained are shown in TABLES 1 and 2. For anti-ß -- Glycoprotein I IgG, further resolution of the discordant samples showed that the three samples that were negative in the Is anti-P.-Glycoprotein I IgG and positive by the other EIA were also negative by a refered ElA method. Of the six samples positive in the Is anti-B -Glycoprotein I IgG and negative in the other EIA, one was positive and five were negative by a referee EIA method. For anti-B,-Glycoprotein I IgM, further resolution of the discordant samples showed that of the four samples that were negative in the Is anti-P .- Glycoprotein I IgM but positive in the other EIA, two were positive and two were negative by a referee EIA method.
C. Clinical Sensitivity and Specificity
A total of three hundred and eighty-eight frozen retrospective, clinically characterized sera were assayed using the Is anti-B,Glycoprotein I IgG/IgM Test Kit in order to assess both the clinical specificity of the assay system. These samples consisted of 248 normal sera, 57 sera from patients with diagnosed anti-phospholipid syndrome (APS), 33 sera from patients with systemic lupus erythernatosus (SLE), 35 sera from patients with other autoimmune diseases such as Sjogren's Syndrome, scleroderma, polymyosits/dermatomyositis and 15 samples from patients with positive RPR titers. Results are summarized in TABLE 3.
D. Cross-Reactivity
To assess the potential for positive results due to cross reactive antibodies, 50 samples which were reactive to various autoantibodies (SSA/SSB, Scl-70. Jo-1, dsDNA, RF and RPR positive) were tested using the Is anti-D2Glycoprotein I IgGligM Test Kit. One sample positive for dsDNA was positive in both the Is anti-P2Glycoprotein I IgG and IgM tests. One sample positive for Scl-70 antibodies was positive in the Is anti-B2Glycoprotein I IgG test. One sample positive for Jo-1 antibodies was positive in both the Is anti-S2Glycoprotein I IgG and IgM tests and one RPR positive sample was positive in the Is anti-B2Glycoprotein I IgM test. The remaining samples were negative.
E. Linearity
To assess the linearity of the Is anti-B>Glycoprotein I IgG/IgM Test Kit several highly positive samples were serially diluted using Sample Diluent and each dilution was then tested in the respective IgG or IgM assay systems. Representative linear regression graphs and scattergrams with 95% confidence intervals are presented in FIGURES 5 and 6.
F. Correlation of Manual and MAGO Plus results
The Is anti-β,Glycoprotein I IgG/IgM Test Kit has been developed for automated as well as manual use. To demonstrate the equivalence of the manual and MAGO Plus procedures, the results of 153 serum samples tested for anti-B, glycoprotein I IgG antibodies and 163 sera tested for anti-B -glycoprotein I IgM tested by both the manual and automated methods were plotted. Scattergrams and regression lines of the results obtained with 95% confidence intervals are shown in FIGURES 7 and 8. The data indicate good correlation with Correlation Coefficients (r) of 0.9720 for anti-B,-glycoprotein I IgG and 0.9513 for anti-B,-glycoprotein I IgM.
G. Precision
To assess the precision of the Is anti-B,Glycoprotein I IgGflgM Test Kit six serum samples of varying reactivity were tested in triplicate in three separate runs. Precision was assessed both manually and using the MAGO Plus Automated EIA Processor. Precision was assessed for both IgG and IgM antibody types. The results obtained using 6-point Calibration are shown in TABLES 4-7.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Relative Sensitivity and Specificity
For anti-ß -- Glycoprotein I IgG:
Relative Sensitivity = 92.7% (95% CI: 80.1-98.5%)
Relative Specificity = 95.3% (95% CI: 90.2-98.3%)
Overall Agreement = 94.7% (95% CI: 90.2-97.6%)
For anti-ß -- Glycoprotein I IgM:
Relative Sensitivity = 88.6 % (95% CI: 73.3-96.8%)
Relative Specificity = 100.0% (95% CI: 97.1-100.0%)
Overall Agreement = 97.5% (95% CI: 93.7-99.3%)
Clinical Specificity and Sensitivity
IgG Clinical Specificity:
Normals: 245/248 = 98.8%
RPR Positive: 15/15 = 100.0%
Other Autoimmune Diseases: 32/35 = 91.4%
IgG Clinical Sensitivity:
APS: 46/57 = 80.7%
SLE: 7/33 = 21.2%
IgM Clinical Specificity:
Normals: 245/248 = 98.8%
RPR Positive: 14/15 = 93.3%
Other Autoimmune Diseases: 33/35 = 94.3%
IgM Clinical Sensitivity:
APS: 25/57 = 43.9%
SLE: 7/33 = 21.2%
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 866.5660 Multiple autoantibodies immunological test system.
(a)
Identification. A multiple autoantibodies immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the autoantibodies (antibodies produced against the body's own tissues) in serum and other body fluids. Measurement of multiple autoantibodies aids in the diagnosis of autoimmune disorders (disease produced when the body's own tissues are injured by autoantibodies).(b)
Classification. Class II (performance standards).
0
DEC 21 2001
510(k) Summary of Safety and Effectiveness
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
The assigned 510(k) number is: _ K O 13628
Applicant Information:
| Date Prepared: | December 18, 2001 |
|---|---|
| Name: | Diamedix Corporation |
| Address: | 2140 N. Miami Avenue |
| Miami, FL 33127 |
| Contact Person: | Dr. Lynne Stirling |
|---|---|
| Phone Number: | 305-324-2354 |
| Fax Number: | 305-324-2388 |
Device Information:
| Trade Name: | Is anti-β₂Glycoprotein I IgG/IgM Test System |
|---|---|
| Common Name: | Anti-β₂Glycoprotein I ELISA test |
| Classification Name: | Anti-β₂Glycoprotein I immunological test system |
Equivalent Device:
QUANTA Lite ß,GPI IgG & QUANTA Lite ß,GPI IgM
Device Description: The Is anti-β, Glycoprotein I IgG/IgM Test System is an enzyme-linked immunosorbent assay (ELISA) for the semi-quantitative measurement of IgG or IgM antibodies to ß, glycoprotein in human serum
Intended Use: The assay is intended for the semi-quantitative measurement of IgG or IgM antibodies to B, glycoprotein I in human serum. The results of the assay can be used as an aid in the diagnosis of certain autoimmune disease thrombotic disorders in patients with SLE or SLE-like dosorders.
Principle of the Procedure:
The Is-anti-ß, Glycoprotein I IgG/IgM Test System is an indirect solid-phase enzyme immunoassay. Highly purified p2-Glycoprotein I is coated onto plastic microwells. Standards, controls and diluted patient samples are added to the wells. Any patient IgG or IgM antibodies in the sample bind to the well. Anti-human IgG or IgM horseradish peroxidase conjugate is then added After incubation and washing, a substrate solution is then added to each well. In the presence of bound enzyme, the substrate is converted to a blue colored product. After acid additon to stop the reaction, a yellow end product is formed that is read spectrophotometrically at 450 nm (reference 600-630 nm) and is directly proportional to the concentration of B2-glycoprotein I IgG or IgM antibodies in the sample.
1
SUMMARY OF SAFETY AND EFFECTIVENESS
Performance Characteristics
All non-clinical studies were performed using the manual method and 6-point calibration unless otherwise indicated.
A. 3-point vs 6-point calibration
To demonstrate the equivalence of both calibration methods, the results of 178 samples tested using the Is-anti-B, Glycoprotein I IgG and 187 samples tested using the Is-anti-B,Glycoprotein I IgM, calculated using either the 3-point Or 6-point calibration systems, were subjected to linear regression analysis. Scattergrams and regression lines of the of of obtained with 95% confidence intervals are shown in FIGURES 1 and 2. Also included are the regression statistics.
Image /page/1/Figure/5 description: This image contains two scatter plots comparing 3-point and 6-point results for Is-anti-β2-Glycoprotein IgG and IgM. The plot on the left, labeled FIGURE 1, shows the correlation for IgG, with the equation Y = 1.6364 + 0.9235 X. Statistical data below the plot includes the intercept, slope, coefficient of determination (0.9812), correlation coefficient (0.9905), and 95% confidence intervals. The plot on the right, labeled FIGURE 2, displays the correlation for IgM, with the equation Y = 1.3859 + 0.9587 X, along with its corresponding statistical data such as a coefficient of determination of 0.9747 and a correlation coefficient of 0.9872.
B. Relative Sensitivity and Specificity
One hundred and seventy-two frozen retrospective sera were tested for IgG antibodies and one hundred and sixty-one One numeros and so very on e ested for IgM antibodies using the Is-anti-B. -Glycoprotein I IgG/IgM Test Kit and commercially available ELISA kits for detecting IgG and IgM B - glycoprotein I antibodies. Based on the results of this testing the relative sensitivity, relative specificity and overall agreement were calculated. The results obtained are shown in TABLES 1 and 2. For anti-ß -- Glycoprotein I IgG, further resolution of the discordant samples showed that the three samples that were negative in the Is anti-P.-Glycoprotein I IgG and positive by the other EIA were also negative by a refered ElA method. Of the six samples positive in the Is anti-B -Glycoprotein I IgG and negative in the other EIA, one was positive and five were negative by a referee EIA method. For anti-B,-Glycoprotein I IgM, further resolution of the discordant samples showed that of the four samples that were negative in the Is anti-P .- Glycoprotein I IgM but positive in the other EIA, two were positive and two were negative by a referee EIA method.
| TABLE
| 1 | |
|---|---|
| ------------ | -- |
| TABL | |
|---|---|
| ------ | -- |
| Is-anti- $\beta_2$ Glycoprotein I IgG | ||||
|---|---|---|---|---|
| Positive | Negative | Equivocal | ||
| Other | ||||
| EIAs | Positive | 38 | 3 | 0 |
| Negative | 6 | 123 | 2 | |
| *Equivocal | 0 | 0 | 0 | |
| **95% CI | ||||
| Relative Sensitivity | 38/41 | = 92.7% | 80.1-98.5% | |
| Relative Specificity | 123/129 | = 95.3% | 90.2-98.3% | |
| Overall Agreement | 161/170 | = 94.7% | 90.2-97.6% |
| 1 | 0
| 1
. |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------|
| ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | | |
| | . 19
A = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = | - Parts & Box C |
| Positive | Negative | Equivocal | |||
|---|---|---|---|---|---|
| Positive | 31 | ব | 2 | ||
| Negative | 0 | 124 | 0 | ||
| *Equivocal | O | 0 | O | ||
| Relative Sensitivity | |||||
| Relative Specificity | 31/35 | ||||
| 124/124 | = 88.6 % | ||||
| = 100.0% | **95% Cl | ||||
| 73.3-96.8% | |||||
| 97.1-100.0% | |||||
| Overall Agreement | 155/159 | = 97.5% | 93.7-99.3% |
- Equivocal results were excluded from calculations. ** 95% Confidence Intervals (CI) calculated by the Exact Method
2
NOTE : Please be advised that 'refers to the comparison of the assay's results to that of a similar assay. There was not an attempt to correlate the assay's results with disease presence or absence. No judgement can be made on the comparison's accuracy to predict disease.
Linear regression analyses and scattergrams for the correlation studies with the comparative methods are shown in FIGURES 3 and 4.
Image /page/2/Figure/2 description: The image contains two scatter plots comparing different methods. The left plot, labeled Figure 3, shows the correlation for anti-β2-Glycoprotein I IgG, with the equation Y = 0.4326 + 1.0857X and a correlation coefficient of 0.9484. The right plot, labeled Figure 4, shows the correlation for anti-β2-Glycoprotein I IgM, with the equation Y = 8.8424 + 2.5781X and a correlation coefficient of 0.9311. Both plots display data points along with regression lines and confidence intervals, and include statistical data such as intercept, slope, coefficient of determination, and confidence intervals for the correlation coefficient.
C. Clinical Sensitivity and Specificity
A total of three hundred and eighty-eight frozen retrospective, clinically characterized sera were assayed using the Is anti-B,Glycoprotein I IgG/IgM Test Kit in order to assess both the clinical specificity of the assay system. These samples consisted of 248 normal sera, 57 sera from patients with diagnosed anti-phospholipid syndrome (APS), 33 sera from patients with systemic lupus erythernatosus (SLE), 35 sera from patients with other autoimmune diseases such as Sjogren's Syndrome, scleroderma, polymyosits/dermatomyositis and 15 samples from patients with positive RPR titers. Results are summarized in TABLE 3.
| TABLE 3 | |||||
|---|---|---|---|---|---|
| IgG | IgM | ||||
| Patient Group | Total | Positive | Negative / Equiv. | Positive | Negative / Equiv. |
| Normals | 248 | 3 | 245 | 3 | 245 |
| APS | 57 | 46 | 11 | 25 | 32 |
| SLE | 33 | 7 | 26 | 7 | 26 |
| Other Autoimmune | |||||
| Diseases | 35 | 3 | 32 | 2 | 33 |
| RPR Positive | 15 | 0 | 15 | 1 | 14 |
| Clinical Specificity: | IgG | IgM | |||
| # Neg or Equiv./Total # | # Neg or Equiv./Total # | ||||
| Normals | 245/248 = 98.8% | 245/248 = 98.8% | |||
| RPR Positive | 15/15 = 100.0% | 14/15 = 93.3% | |||
| Other Autoimmune | |||||
| Diseases | 32/35 = 91.4% | 33/35 = 94.3% | |||
| Clinical Sensitivity : | IgG | IgM | |||
| # Pos/Total # | # Pos/Total # | ||||
| APS | 46/57 = 80.7% | 25/57 = 43.9% | |||
| SLE | 7/33 = 21.2% | 7/33 = 21.2% |
3
D. Cross-Reactivity
To assess the potential for positive results due to cross reactive antibodies, 50 samples which were reactive to various autoantibodies (SSA/SSB, Scl-70. Jo-1, dsDNA, RF and RPR positive) were tested using the Is anti-D2Glycoprotein I IgGligM Test Kit. One sample positive for dsDNA was positive in both the Is anti-P2Glycoprotein I IgG and IgM tests. One sample positive for Scl-70 antibodies was positive in the Is anti-B2Glycoprotein I IgG test. One sample positive for Jo-1 antibodies was positive in both the Is anti-S2Glycoprotein I IgG and IgM tests and one RPR positive sample was positive in the Is anti-B2Glycoprotein I IgM test. The remaining samples were negative.
E. Linearity
To assess the linearity of the Is anti-B>Glycoprotein I IgG/IgM Test Kit several highly positive samples were serially diluted using Sample Diluent and each dilution was then tested in the respective IgG or IgM assay systems. Representative linear regression graphs and scattergrams with 95% confidence intervals are presented in FIGURES 5 and 6.
Image /page/3/Figure/4 description: This image contains two plots, labeled as Figure 5 and Figure 6, which show the linearity of Is-anti-β2-Glycoprotein IgG and IgM, respectively. Both plots display a linear relationship between dilution and concentration (Conc. U/ml). Figure 5 includes a regression equation of Y = 1.6732 + 107.5806, with an intercept of 1.67318 and a slope of 107.58059, while Figure 6 has a regression equation of Y = 3.3897 + 103.2019, with an intercept of 4.5071 and a slope of 118.93019.
DILUTION
4
F. Correlation of Manual and MAGO Plus results
The Is anti-β,Glycoprotein I IgG/IgM Test Kit has been developed for automated as well as manual use. To demonstrate the equivalence of the manual and MAGO Plus procedures, the results of 153 serum samples tested for anti-B, glycoprotein I IgG antibodies and 163 sera tested for anti-B -glycoprotein I IgM tested by both the manual and automated methods were plotted. Scattergrams and regression lines of the results obtained with 95% confidence intervals are shown in FIGURES 7 and 8. The data indicate good correlation with Correlation Coefficients (r) of 0.9720 for anti-B,-glycoprotein I IgG and 0.9513 for anti-B,-glycoprotein I IgM.
Image /page/4/Figure/2 description: This image contains two scatter plots comparing Manual and MAGO Plus correlation for anti-beta2-Glycoprotein I IgG and IgM. The left plot, labeled Figure 7, shows the IgG correlation with an intercept of 3.6553 and a slope of 1.2255. The right plot, labeled Figure 8, shows the IgM correlation with an intercept of 0.1548 and a slope of 1.6209. Both plots display a strong positive correlation, with correlation coefficients of 0.9720 and 0.9704, respectively.
With the 3-point calibration, linear regression of the IgG results showed (automated) = 1.1553 (manual) + 2.6132; r = 0.9766. 95% CI for the slope and intercept are 1.1144 to 1.1961 and 1.7875 to 3.4388 respectively. For IgM results (automated) = 1.2244 (manual) + 1.1552; r =9869. 95% CI for the slope and intercept 1.1956 to 1.2532 and 0.4133 to 1.8971 respectively.
G. Precision
To assess the precision of the Is anti-B,Glycoprotein I IgGflgM Test Kit six serum samples of varying reactivity were tested in triplicate in three separate runs. Precision was assessed both manually and using the MAGO Plus Automated EIA Processor. Precision was assessed for both IgG and IgM antibody types. The results obtained using 6-point Calibration are shown in TABLES 4-7.
| SERUM | INTRA-ASSAY RUN 1 | INTRA-ASSAY RUN 2 | INTRA-ASSAY RUN 3 | INTERASSAY (n=9) | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| MEAN U/ml | SD | CV% | MEAN U/ml | SD | CV% | MEAN U/ml | SD | CV% | MEAN U/ml | SD | CV% | |
| A | 1.8 | 0.208 | 11.35 | 1.7 | 0.153 | 8.81 | 2.0 | 0.153 | 7.77 | 1.8 | 0.181 | 9.82 |
| B | 3.0 | 0.208 | 7.02 | 3.1 | 0.300 | 9.68 | 3.3 | 0.173 | 5.25 | 3.1 | 0.249 | 7.97 |
| C | 25.9 | 0.252 | 0.97 | 25.7 | 0.058 | 0.22 | 26.8 | 0.557 | 2.08 | 26.1 | 0.589 | 2.26 |
| D | 33.6 | 0.850 | 2.53 | 32.0 | 1.193 | 3.73 | 31.7 | 1.662 | 5.25 | 32.4 | 1.439 | 4.44 |
| E | 46.7 | 0.700 | 1.50 | 44.6 | 0.608 | 1.36 | 45.5 | 0.643 | 1.41 | 45.6 | 1.074 | 2.36 |
| F | 57.4 | 8.088 | 14.09 | 59.1 | 1.332 | 2.25 | 59.4 | 3.675 | 6.19 | 58.6 | 4.587 | 7.82 |
TABLE 4 : Manual Intra-Assay and Interassay Precision for Is-anti-B,-Glycoprotein I IgG
| TABLE 5 : MAGO Plus - Intra-Assay and Interassay Precision for Is-anti-B,-Glycoprotein I IgG | ||||
|---|---|---|---|---|
| ---------------------------------------------------------------------------------------------- | -- | -- | -- | -- |
| SERUM | INTRA-ASSAY RUN 1 | INTRA-ASSAY RUN 2 | INTRA-ASSAY RUN 3 | INTERASSAY (n=9) | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| MEAN | ||||||||||||
| U/ml | SD | CV% | MEAN | |||||||||
| U/ml | SD | CV% | MEAN | |||||||||
| U/ml | SD | CV% | MEAN | |||||||||
| U/ml | SD | CV% | ||||||||||
| A | 6.2 | 0.929 | 15.07 | 5.2 | 0.058 | 1.12 | 4.5 | 0.458 | 10.18 | 5.3 | 0.893 | 16.91 |
| B | 8.6 | 1.930 | 22.35 | 7.1 | 0.306 | 4.32 | 5.5 | 0.503 | 9.21 | 7.1 | 1.702 | 24.13 |
| C | 34.3 | 1.916 | 5.59 | 33.3 | 0.643 | 1.93 | 32.2 | 1.930 | 5.99 | 33.3 | 1.659 | 4.99 |
| D | 51.7 | 2.330 | 4.51 | 42.7 | 3.857 | 9.03 | 48.8 | 3.009 | 6.17 | 47.7 | 4.811 | 10.08 |
| E | 59.3 | 1.716 | 2.89 | 60.1 | 3.650 | 6.07 | 58.3 | 3.764 | 6.46 | 59.2 | 2.867 | 4.84 |
| F | 89.6 | 4.521 | 5.05 | 88.1 | 2.409 | 2.74 | 88.6 | 3.119 | 3.52 | 88.8 | 3.074 | 3.46 |
5
TABLE 6 : Manual Intra-Assay and Interassay Precision for Is-anti-β ,-Glycoprotein IgM
| SERUM | INTRA-ASSAY RUN 1 | INTRA-ASSAY RUN 2 | INTRA-ASSAY RUN 3 | INTERASSAY (n=9) | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| MEAN U/ml | SD | CV% | MEAN U/ml | SD | CV% | MEAN U/ml | SD | CV% | MEAN U/ml | SD | CV% | |
| A | 1.2 | 0.208 | 17.84 | 1.1 | 0.208 | 19.52 | 0.9 | 0.058 | 6.19 | 1.1 | 0.181 | 17.15 |
| B | 4.8 | 0.208 | 4.37 | 4.9 | 0.000 | 0.00 | 4.6 | 0.208 | 4.49 | 4.8 | 0.187 | 3.92 |
| C | 13.2 | 1.940 | 14.73 | 12.9 | 1.375 | 10.66 | 12.2 | 0.100 | 0.82 | 12.8 | 1.266 | 9.93 |
| D | 19.3 | 1.790 | 9.26 | 18.3 | 2.003 | 10.97 | 15.2 | 1.480 | 9.74 | 17.6 | 2.409 | 13.69 |
| E | 37.8 | 3.499 | 9.26 | 39.4 | 4.451 | 11.30 | 36.7 | 0.153 | 0.42 | 38.0 | 3.062 | 8.06 |
| F | 51.7 | 2.330 | 4.51 | 54.2 | 3.318 | 6.12 | 55.5 | 0.781 | 1.41 | 53.8 | 2.657 | 4.94 |
TABLE 7 : MAGO Plus - Intra-Assay and Interassay Precision for Is-anti-ß -Glýcoprotein IgM
| SERUM | INTRA-ASSAY RUN 1 | INTRA-ASSAY RUN 2 | INTRA-ASSAY RUN 3 | INTERASSAY (n=9) | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| MEAN U/ml | SD | CV% | MEAN U/ml | SD | CV% | MEAN U/ml | SD | CV% | MEAN U/ml | SD | CV% | ||
| A | 2.1 | 0.361 | 17.17 | 1.6 | 0.173 | 10.83 | 2.0 | 0.265 | 13.23 | 1.9 | 0.332 | 17.46 | |
| B | 6.2 | 0.306 | 4.90 | 6.5 | 0.529 | 8.14 | 7.3 | 0.709 | 9.76 | 6.7 | 0.660 | 9.89 | |
| C | 16.8 | 2.454 | 14.64 | 19.2 | 3.453 | 18.02 | 22.0 | 4.466 | 20.33 | 19.3 | 3.815 | 19.77 | |
| D | 21.5 | 2.369 | 11.00 | 26.4 | 1.823 | 6.90 | 25.8 | 1.069 | 4.15 | 24.6 | 2.796 | 11.38 | |
| E | 43.4 | 2.754 | 6.35 | 48.9 | 2.646 | 5.41 | 53.0 | 3.958 | 7.46 | 48.4 | 5.020 | 10.37 | |
| F | 65.3 | 9.794 | 15.01 | 77.6 | 1.501 | 1.93 | 75.7 | 4.130 | 5.45 | 72.9 | 7.878 | 10.81 |
6
Expected Values
The prevalence of anti-9,-glycoprotein I IgG and/or IgM antibodies may vary depending on a number of factors such as age, gender, geographical location, race, type of test used and clinical history of individual patients. Antibodies to anti-B.glycoprotein I are generally absent, or have a very low incidence, in the normal healthy population. In a recently published study the distribution of anti-ß, glycoprotein I antibodies in healthy controls was 3%. In patients with SLE the prevalence of B.glycoprotein IgG & IgM antibodies has been found to range from 20-30%. The prevalence of these antibodies in anti-phospholipid syndrome (APS) patients has been found to range from 40 to 65%.
In the present study, the expected values for a normal, healthy population were assessed by testing sera from one hundred and forty-eight S. Florida blood donors in the Is-anti-B, Glycoprotein I IgG/IgM Test Kit for both IgM antibodies. Ninety-eight of these samples were from males and 50 were from females. For IgG antibodies, one hundred and forty-five sera (98.0%) were negative for antibodies, two sera (1.3%) were positive and one serum (0.7%) was equivocal. For IgM antibodies, one hundred and forty-three (96.6%) were negative, three sera (2.0%) were positive and two sera (1.4%) were equivocal. The gender, age distribution and antibody prevalences for this population are shown in TABLE 8.
The expected values for a clinical population were assessed by testing fifty-seven sera from patients with a diagnosis of anti-phospholipid syndrome (APS) in the Is-anti-β, Glycoprotein IIgG/lgM test for both antibody types. Forty-six (80.7%) were positive, ten (17.5%) were negative and one (1.8%) was equivocal for IgG antibodies. Twenty-seven (43.8%) were positive, twenty-nine (52.6%) were negative, and two (3.6%) was equivocal for IgM antibodies.
Histograms showing the distribution of values for the normal and clinical populations for both IgG and IgM antibodies are shown in FIGURES 9-12.
| Number of Donors | Prevalence | ||
|---|---|---|---|
| Total Number | 148 | IgG | IgM |
| Geographic | |||
| Location: | South Florida : 148 | 1.3% | 2.0% |
| Age | |||
| 10-19 | 7 | 14.3% | 0.0% |
| 20-29 | 36 | 0.0% | 0.0% |
| 30-39 | 73 | 1.4% | 2.7% |
| 40-49 | 22 | 0.0% | 0.0% |
| 50-59 | 8 | 0.0% | 0.0% |
| 60-69 | 2 | 0.0% | 0.0% |
| TABLE 8: Age Distribution and Prevalence of anti-β,-Glycoprotein IgG and IgM | |||
|---|---|---|---|
| Antibodies in a Normal S. Florida Population |
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Image /page/7/Figure/0 description: This image is a bar graph showing the frequency of Is-anti-B2 Glycoprotein IgG U/ml. The x-axis represents the Is-anti-B2 Glycoprotein IgG U/ml, and the y-axis represents the frequency. The bar graph shows that the frequency is highest between 0 and 5, with a frequency of approximately 140. The frequency is very low between 5 and 45, and then increases slightly between 45 and 50.
FIGURE 9
Distribution of anti-β,Glycoprotein I IgG in a Normal Population
FIGURE 10 Distribution of anti-β,Glycoprotein I IgM in a Normal Population
Image /page/7/Figure/2 description: This image is a histogram showing the frequency of Is-B2 Glycoprotein IgM levels in U/ml. The x-axis represents the Is-B2 Glycoprotein IgM levels, ranging from 0 to 26 U/ml. The y-axis represents the frequency, ranging from 0 to 140. The histogram shows a high frequency of IgM levels between 0 and 2 U/ml, with the frequency decreasing as the IgM levels increase.
FIGURE 11 Distribution of anti-β,Glycoprotein IgG I in a Clinical Population
FIGURE 12 Distribution of anti-β₂Glycoprotein IgM I in a Clinical Population
Image /page/7/Figure/5 description: The image is a histogram showing the frequency of Is-B2 Glycoprotein IgG U/ml. The x-axis represents the Is-B2 Glycoprotein IgG U/ml, ranging from 0 to 180. The y-axis represents the frequency, ranging from 0 to 10. The histogram shows that the frequency is highest at 0, and then decreases as the Is-B2 Glycoprotein IgG U/ml increases, with a second peak at 160.
Image /page/7/Figure/6 description: The image is a histogram showing the frequency of is-B2-Glycoprotein IgM. The x-axis represents the is-B2-Glycoprotein IgM values, ranging from 0 to 140. The y-axis represents the frequency, ranging from 0 to 40. The histogram shows a high frequency at the lower end of the x-axis, with the highest frequency around 40, and then decreases as the x-axis values increase.
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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 emblem featuring three curved lines that resemble a stylized human figure.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
DEC 21 2001
Dr. Lynne Stirling VP Regulatory Affairs Diamedix Corporation 2140 N. Miami Avenue Miami, FL 33127
Re: K013628
Trade/Device Name: Is anti-B,-Glycoprotein I IgG/IgM Regulation Number: 21 CFR 866.5660 Regulation Name: Multiple autoantibodies immunological test system Regulatory Class: Class II Product Code: MSV Dated: October 31, 2001 Received: November 5, 2001
Dear Dr. Stirling:
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 such 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); 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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This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and ' additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely yours,
Steven Gutman
Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory-Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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INDICATIONS FOR USE STATEMENT
510(K) NUMBER : KO13628
DEVICE NAME : Is anti-β₂-Glycoprotein | IgG/IgM Test System
Indications for Use : The Diamedix Is anti-β ,Glycoprotein | IgG/IgM Test Kit is indications for OSS inmunoassay (EIA) for the semi-quantitative measurement of IgG or IgM antibodies to ßglycoprotein I in human serum as an aid in the diagnosis of certain autoimmune disease thrombotic disorders in patlents with SLE or SLE-like disorders. These reagents can be used either manually or in conjunction with the MAGO® Plus Automated EIA Processor.
Prescription Use
N
Rev. 12/18
(Division Sign-Off) (Division Sign-On)
Division of Clinical Laboratory Devices
Clinical Laboratory 510(k) Number