(77 days)
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No
The device description and performance studies describe a standard ELISA assay and its performance characteristics. There is no mention of AI or ML in the intended use, device description, or performance evaluation. The "MAGO" mentioned appears to be an automated system for running the ELISA, not an AI/ML component for interpretation.
No
The device is an in vitro diagnostic assay intended for aiding in the diagnosis of autoimmune disorders by detecting antibodies, not for treating or preventing a disease.
Yes
The device is described as an "aid in the diagnosis of autoimmune disorders" and is an "enzyme-linked immunosorbent assay (ELISA) for the detection and semi-quantitation of IgG to SSB (La) antigen in human serum." This clearly indicates its use in making a medical diagnosis.
No
The device description explicitly states it is an "enzyme-linked immunosorbent assay (ELISA) for the detection and semi-quantitation of IgG to SSB (La) antigen in human serum," which is a laboratory test kit involving physical reagents and procedures, not software alone.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's for "detecting antibodies to SSB (La) antigen in a single human serum sample" and the results are to be used "as an aid in the diagnosis of autoimmune disorders." This involves testing a sample taken from the human body in vitro (outside the body) to provide diagnostic information.
- Device Description: The description confirms it's an "enzyme-linked immunosorbent assay (ELISA) for the detection and semi-quantitation of IgG to SSB (La) antigen in human serum." ELISA is a common in vitro diagnostic technique.
- Sample Type: The assay uses "human serum," which is a biological sample taken from a human.
These points clearly align with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The assay is intended for use in detecting antibodies to SSB (La) antigen in a single human serum sample. The results of the assay are to be used as an aid in the diagnosis of autoimmune disorders.
Product codes (comma separated list FDA assigned to the subject device)
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Device Description
The Is-anti-SSB Test Kit System is an enzyme-linked immunosorbent assay (ELISA) for the detection and semi-quantitation of IgG to SSB (La) antigen in human serum.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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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. Comparison Testing
The Diamedix Is-anti-SSB Test Kit was evaluated relative to another commercially available anti-SSB ELISA test kit using clinically characterized sera. One hundred sera from normal blood donors and 65 sera from autoimmune patients were tested by Is-anti-SSB and a commercially obtained anti-SSB ELISA test kit.
Relative Sensitivity: 38/40 (95%, 95% Confidence 83-99) for both Manual and MAGO.
Relative Specificity: 124/124 (100%, 95% Confidence 97-100) for both Manual and MAGO.
Agreement: 162/164* (99%, 95% Confidence 96-100) for both Manual and MAGO.
- One borderline sample was excluded from the calculation.
Two sera were negative in Is-anti-SSB and positive in the comparative method (manual and MAGO). Upon retest by a referee method, one of the sera was positive, the other was negative.
B. Linearity
Figures 1 and 2 show typical examples of Is-anti-SSB Test Kit linearity. The figures depict the results of the Calibrator tested by Is-anti-SSB after a serial two-fold manual dilution in Sample Diluent. Separate dilutions were tested both manually and with MAGO. The results demonstrate a high degree of linearity for the Is-anti-SSA Test Kit throughout the testing range.
R-squared value of 0.9829 for Manual linearity and 0.9874 for MAGO linearity.
C. Precision
The precision of the Is-anti-SSB Test Kit was determined by testing six different sera and kit Calibrator and controls in two runs on three different days.
Intra-CV% for Manual ranged from 2.5% to 10.3%. Inter-CV% for Manual ranged from 5.3% to 30.0%.
Intra-CV% for MAGO ranged from 3.0% to 53.0%. Inter-CV% for MAGO ranged from 8.3% to 50.0%.
D. Crossreactivity
Twenty-four sera positive for the six autoimmune specificities were tested in Is-anti-SSB Test Kit. Only samples positive for SSB showed a positive result (EU/ml values of 236.2, 48.3, 148.3, 128.4), while samples positive for SSA, Sm, RNP, Jo-1, and Scl-70 showed negative results.
E. Expected Values
The expected values in the normal population were determined by assaying 100 normal donor sera collected in South Florida. Figures 3 and 5 show the distribution of SSB results in the normal population performed manually and on MAGO respectively.
The distribution of EU/ml values for 65 clinically characterized sera along with the 100 normal donor sera are shown in Figures 4 and 6 performed manually and on MAGO respectively.
F. Correlation of Manual and MAGO Results
Numerical comparison of EU/ml values, between manual and MAGO results for 165 samples in the Is-anti-SSB Test Kit showed a correlation of 0.91 (Pearson).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Relative Sensitivity: 95%
Relative Specificity: 100%
Agreement: 99%
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Helix Diagnostics Enzyme Immunoassav Anti-SS-B/La Antibody Test Kit
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 866.5100 Antinuclear antibody immunological test system.
(a)
Identification. An antinuclear antibody immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the autoimmune antibodies in serum, other body fluids, and tissues that react with cellular nuclear constituents (molecules present in the nucleus of a cell, such as ribonucleic acid, deoxyribonucleic acid, or nuclear proteins). The measurements aid in the diagnosis of systemic lupus erythematosus (a multisystem autoimmune disease in which antibodies attack the victim's own tissues), hepatitis (a liver disease), rheumatoid arthritis, Sjögren's syndrome (arthritis with inflammation of the eye, eyelid, and salivary glands), and systemic sclerosis (chronic hardening and shrinking of many body tissues).(b)
Classification. Class II (performance standards).
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510(k) Summary of Safety and Effectiveness
This summary of 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:
Applicant Information:
| Date Prepared: | January 15, 1997 |
|---|---|
| Name: | Diamedix Corporation |
| Address: | 2140 N. Miami Avenue |
| Miami, FL 33127 | |
| Contact Person: | Dr. Lynne Stirling |
| Contact Person: | Dr. Lynne Stirling |
| Phone Number: | 305-324-2354 |
| Fax Number: | 305-324-2585 |
Device Information:
Trade Name: Is-(immunosimplicity)-anti-SSB Test System Common Name: Anti-SSB EIA Test Classification Name: Extractable Antinuclear Antibody
Equivalent Device:
Helix Diagnostics Enzyme Immunoassav Anti-SS-B/La Antibody Test Kit
Device Description: The Is-anti-SSB Test Kit System is an enzyme-linked immunosorbent assay (ELISA) for the detection and semi-quantitation of IgG to SSB (La) antigen in human serum.
Intended use: The assay is intended for use in detecting antibodies to SSB (La) antigen in a single human serum sample. The results of the assay are to be used as an aid in the diagnosis of autoimmune disorders.
Comparison to Predicate Device:
The Is-anti-SSB Test System is an enzyme-linked immunosorbent assay to detect IgG to SSB (La) in human serum. Purified SSB (La) antigen is attached to a solid phase microtiter well. Diluted test sera are added to each well. If antibodies which recognize the SSB antigen are present in the patient sample, they will bind to the antigen in the well. After incubation, the wells are washed to remove unbound antibody. An enzyme-labeled anti-human immunoglobulin (conjugate) is added to each test well. If antibody is present the enzyme-linked antibody will bind to it. After incubation, the wells are washed to remove unbound conjugate. A substrate solution is then added to each well. If enzyme is present from the prior step, the substrate will be converted to produce a colored product. The reaction is stopped and the color intensity is measured photometrically providing an indirect measure of the specific antibody present in the patient sample.
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Summary of Safety and Effectiveness
Performance Characteristics
A. Comparison Testing
The Diamedix Is-anti-SSB Test Kit was evaluated relative to another commercially available anti-SSB ELISA test kit using clinically characterized sera. One hundred sera from normal blood donors and 65 sera from autoimmune patients were tested by Is-anti-SSB and a commercially obtained anti-SSB ELISA test kit. The results are summarized in Table 1. below.
| Table 1 | Manual | MAGO | ||||
|---|---|---|---|---|---|---|
| Number of Sera | % | 95% Confidence | Number of Sera | % | 95% Confidence | |
| Relative Sensitivity | 38/40 | 95 | 83-99 | 38/40 | 95 | 83-99 |
| Relative Specificity | 124/124 | 100 | 97-100 | 124/124 | 100 | 97-100 |
| Agreement | 162/164* | 99 | 96-100 | 162/164* | 99 | 96-100 |
- One borderline sample was excluded from the calculation.
Two sera were negative in Is-anti-SSB and positive in the comparative method (manual and MAGO). Upon retest by a referee method, one of the sera was positive, the other was negative.
B. Linearity
Figures 1 and 2 show typical examples of Is-anti-SSB Test Kit linearity. The figures depict the results of the Calibrator tested by Is-anti-SSB after a serial two-fold manual dilution in Sample Diluent. Separate dilutions were tested both manually and with MAGO. The results demonstrate a high degree of linearity for the Is-anti-SSA Test Kit throughout the testing range.
Image /page/1/Figure/9 description: The image contains two line graphs titled "Is anti-SSB Calibrator Linearity". Both graphs show the relationship between dilution and absorbance. The first graph has an R-squared value of 0.9829, while the second graph has an R-squared value of 0.9874, indicating a strong positive correlation between dilution and absorbance in both graphs.
Figurel. Manual Linearity
Figure 2. MAGO Linearity
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C. Precision
The precision of the Is-anti-SSB Test Kit was determined by testing six different sera and kit Calibrator and controls in two runs on three different days. The intra- and inter assay precision is shown in Table 2.
| Table 2 | anti-SSB PRECISION | ||||
|---|---|---|---|---|---|
| OVERALL | MANUAL | MAGO | |||
| SERUM | MEAN | ||||
| EU/ml | INTRA-CV% | INTER-CV% | INTRA-CV% | INTER-CV% | |
| 1 (NEG) | 1.4 | 10.1 | 21.4 | 27.3 | 30.8 |
| 2 (NEG) | 1.4 | 4.3 | 6.3 | 13.9 | 16.7 |
| 3 (POS) | 37.5 | 4.5 | 11.2 | 8.2 | 11.2 |
| 4 (POS) | 29.7 | 4.1 | 10.4 | 4.1 | 9.2 |
| 5 (POS) | 55.4 | 4.0 | 8.0 | 4.0 | 8.3 |
| 6 (POS) | 96.9 | 3.5 | 5.3 | 3.0 | 8.7 |
| CAL | 100.8 | 4.2 | 6.5 | 5.6 | 10.1 |
| POS CTRL | 39.8 | 2.5 | 8.5 | 4.5 | 11.3 |
| NEG CTRL | 0.9 | 10.3 | 30.0 | 53.0 | 50.0 |
D. Crossreactivity
Twenty-four sera positive for the six autoimmune specificities were tested in Is-anti-SSB Test Kit. The results are shown in Table 3
| Sample | Is-anti-SSB EU/ml | Interp | Specificity |
|---|---|---|---|
| 1 | 5.5 | Neg | SSA |
| 2 | 3.7 | Neg | SSA |
| 3 | 0.9 | Neg | SSA |
| 4 | 1.6 | Neg | SSA |
| 5 | 236.2 | Pos | SSB |
| 6 | 48.3 | Pos | SSB |
| 7 | 148.3 | Pos | SSB |
| 8 | 128.4 | Pos | SSB |
| 9 | 6.3 | Neg | Sm |
| 10 | 1.4 | Neg | Sm |
| 11 | 1.1 | Neg | Sm |
| 12 | 1.6 | Neg | Sm |
| 13 | 3.7 | Neg | RNP |
| 14 | 2.1 | Neg | RNP |
| 15 | 2.3 | Neg | RNP |
| 16 | 3.3 | Neg | RNP |
| 17 | 1.4 | Neg | Jo-1 |
| 18 | 4.5 | Neg | Jo-1 |
| 19 | 1.5 | Neg | Jo-1 |
| 20 | 1.7 | Neg | Jo-1 |
| 21 | 2.1 | Neg | Scl-70 |
| 22 | 2.5 | Neg | Scl-70 |
| 23 | 2.3 | Neg | Scl-70 |
| 24 | 1.8 | Neg | Scl-70 |
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| Table 3 | Crossreactivity | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| -- | -- | --------- | -- | -- | -- | -- | -- | ----------------- | -- | -- | -- | -- |
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E. Expected Values
The expected values in the normal population were determined by assaying 100 normal donor sera collected in South Florida. Figures 3 and 5 show the distribution of SSB results in the normal population performed manually and on MAGO respectively.
The distribution of EU/ml values for 65 clinically characterized sera along with the 100 normal donor sera are shown in Figures 4 and 6 performed manually and on MAGO respectively.
Image /page/3/Figure/3 description: The image is a graph titled "Is anti-SSB Normals". The x-axis is labeled "Number of Sera" and ranges from 0 to 100. The y-axis is labeled "EU/ml" and ranges from 0.0 to 30.0, with a horizontal line at 20.0. There is a line plot that starts near 0.0 and gradually increases to just under 10.0 at the end of the x-axis.
Image /page/3/Figure/4 description: The image is a graph titled "Is anti-SSB Expected Values". The x-axis is labeled "Number of Sera" and ranges from 0 to 160. The y-axis is labeled "EU/ml" and ranges from 0.0 to 250.0. The graph shows a line that is relatively flat until the x-axis reaches approximately 120, at which point the line increases sharply.
Figure 3. Manual Normals
Figure 4. Manual Expected Values
Image /page/3/Figure/7 description: The image is a graph titled "Is anti-SSB Normals". The x-axis is labeled "Number of Sera" and ranges from 0 to 100. The y-axis is labeled "EU/ml" and ranges from 0.0 to 30.0. A horizontal line is drawn at the 20.0 mark, and a curve is plotted that starts near 0.0 and increases to around 7.0 at the 100 mark.
Image /page/3/Figure/8 description: The image is a graph that shows the EU/ml on the y-axis and the number of sera on the x-axis. The y-axis ranges from 0.0 to 250.0, and the x-axis ranges from 0 to 150. The graph shows a horizontal line at around 10 EU/ml until the number of sera reaches around 120, then the graph increases sharply to around 170 EU/ml at 160 sera.
Figure 5 MAGO Normals
Figure 6. MAGO Expected Values
F. Correlation of Manual and MAGO Results
Numerical comparison of EU/ml values, between manual and MAGO results for 165 samples in the Is-anti-SSB Test Kit showed a correlation of 0.91 (Pearson).
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