(77 days)
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No
The device description and performance studies describe a standard ELISA assay, which is a biochemical test and does not inherently involve AI or ML. There are no mentions of AI, ML, or related concepts in the provided text.
No
This device is an in vitro diagnostic (IVD) test used to aid in the diagnosis of autoimmune disorders by detecting antibodies; it does not treat or cure a disease, which is the function of a therapeutic device.
Yes
The device is described as an aid in the diagnosis of autoimmune disorders, which fits the definition of a diagnostic device. It detects specific antibodies in human serum to assist in diagnosis, as evidenced by "The results of the assay are to be used as an aid in the diagnosis of autoimmune disorders."
No
The device description explicitly states it is an "enzyme-linked immunosorbent assay (ELISA) for the detection and semi-quantitation of IgG to Scl-70 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 Scl-70 antigen in a single human serum sample" and the results are used "as an aid in the diagnosis of autoimmune disorders." This clearly indicates it's used to examine specimens derived from the human body to provide information for diagnostic purposes.
- Device Description: The description states it's an "enzyme-linked immunosorbent assay (ELISA) for the detection and semi-quantitation of IgG to Scl-70 antigen in human serum." ELISA is a common in vitro diagnostic technique.
- Sample Type: The assay uses "human serum," which is a specimen derived from the human body.
These points align directly 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 Scl-70 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-Scl-70 Test Kit System is an enzyme-linked immunosorbent assay (ELISA) for the detection and semi-quantitation of IgG to Scl-70 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)
Comparison Testing: The Diamedix Is-anti-Scl-70 Test Kit was evaluated relative to another commercially available anti-Scl-70 test. This involved testing 138 normal blood donors and 63 sera from autoimmune patients.
Relative Sensitivity (Manual): 21/24 (88% with 95% Confidence Interval 68-97)
Relative Sensitivity (MAGO): 22/24 (92% with 95% Confidence Interval 73-99)
Relative Specificity (Manual): 138/138 (100% with 95% Confidence Interval 97-100)
Relative Specificity (MAGO): 138/139 (99% with 95% Confidence Interval 96-100)
Agreement (Manual): 159/162* (98% with 95% Confidence Interval 95-100)
Agreement (MAGO): 160-163 (98% with 95% Confidence Interval 95-100)
*One equivocal sample was excluded from the calculations.
Linearity: The results demonstrate a high degree of linearity for the Is-anti-Scl-70 Test Kit throughout the testing range, with R-squared values of 0.9873 for Manual Linearity and 0.9888 for MAGO Linearity.
Precision Testing: Determined by testing six different sera and two controls (Calibrator, Positive Control, Negative Control) over three different days.
Intra-assay precision (CV%): Manual ranged from 1.5% to 12.6%; MAGO ranged from 1.8% to 20.2%.
Inter-assay precision (CV%): Manual ranged from 3.1% to 14.3%; MAGO ranged from 3.5% to 29.4%.
Crossreactivity: Twenty-four sera positive for six autoimmune specificities (SSA, SSB, Sm, RNP, Jo-1, Scl-70) were tested.
All 20 sera positive for SSA, SSB, Sm, RNP, and Jo-1 were negative by Is-anti-Scl-70 Test Kit.
All 4 sera positive for Scl-70 were positive by Is-anti-Scl-70 Test Kit.
Expected Values: Determined by assaying 100 normal donor sera collected in South Florida. The distribution of EU/ml values for 50 clinically characterized sera along with the 100 normal donor sera were also shown.
Correlation of Manual and MAGO Results: Numerical comparison of EU/ml values for 150 samples showed a Pearson correlation of 0.99.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Relative Sensitivity (Manual): 88%
Relative Specificity (Manual): 100%
Relative Sensitivity (MAGO): 92%
Relative Specificity (MAGO): 99%
Agreement (Manual): 98%
Agreement (MAGO): 98%
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 Immunoassay Anti-Scl-70 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 sefety 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 |
|---|---|
| Phone Number: | 305-324-2354 |
| Fax Number: | 305-324-2585 |
Device Information:
| Trade Name: | Is-(immunosimplicity)-anti-Scl-70 Test System |
|---|---|
| Common Name: | Anti-Scl-70 EIA Test |
| Classification Name: | Extractable Antinuclear Antibody |
Equivalent Device:
Helix Diagnostics Enzyme Immunoassay Anti-Scl-70 Antibody Test Kit
Device Description: The Is-anti-Scl-70 Test Kit System is an enzyme-linked immunosorbent assay (ELISA) for the detection and semi-quantitation of IgG to Scl-70 antigen in human serum.
Intended use: The assay is intended for use in detecting antibodies to Scl-70 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-Scl-70 Test System is an enzyme-linked immunosorbent assay to detect IgG to Scl-70 in human serum. Purified Scl-70 antigen is attached to a solid phase microtiter well. Diluted test sera are added to each well. If antibodies which recognize the Scl-70 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-Scl-70 Test Kit was evaluated relative to another commercially available anti-Scl-70 The Diamedia Is-anti-OSF 70 Test In normal blood donors and 63 sera from autoimmune patients. The results are summarized in Table 1 below.
| Table 1 | Manual | MAGO | ||||
|---|---|---|---|---|---|---|
| Number of | ||||||
| Sera | % | 95% | ||||
| Confidence | Number of | |||||
| Sera | % | 95% | ||||
| Confidence | ||||||
| Relative | ||||||
| Sensitivity | 21/24 | 88 | 68-97 | 22/24 | 92 | 73-99 |
| Relative | ||||||
| Specificity | 138/138 | 100 | 97-100 | 138/139 | 99 | 96-100 |
| Agreement | 159/162* | 98 | 95-100 | 160-163 | 98 | 95-100 |
- One equivocal sample was excluded from the calculations.
Three sera negative by Is-anti-Scl-70 (manual) and positive by the comparative method were negative when tested by a third method. Two sera negative by Is-anti-Scl-70 (MAGO) and positive by the when wethod were negative when tested by a third method. One serum positive by Is-anti-Scl-70 (MAGO) and negative by the comparative method was positive when tested by a third method. Two of the discordant sera were from patient samples.
B. Linearity
Figures 1 and 2 show typical examples of Is-anti-Scl-70 Test Kit linearity. The figures depict the results of the Calibrator tested by Is-anti-Scl-70 after serial two-fold manual dilutions in Sample Diluent. Separate dilutions were tested both manually and with MAGO. The results demonstrate a high degree of linearity for the Is-anti-Scl-70 Test Kit throughout the testing range.
Image /page/1/Figure/9 description: The image contains two line graphs, both titled "Is-anti-Scl-70 Calibrator Linearity". Both graphs plot "Absorbance" on the y-axis versus "Dilution" on the x-axis. The graph on the left has an R-squared value of 0.9873, while the graph on the right has an R-squared value of 0.9888.
Figure 1 Manual Linearity
Figure 2 MAGO Linearity
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C. Precision Testing
The precision of the Is-anti-Scl-70 Test Kit was determined at Diamedix by testing six different sera and The precision of the Is and Oo. To 100 itthree different days. The intra- and interassay precision is shown in Table 2 below.
| Table 2 | anti-Scl-70 PRECISION | ||||
|---|---|---|---|---|---|
| Overall | |||||
| MEAN EU/ml | MANUAL | MAGO | |||
| SERUM | INTRA-CV% | INTER-CV% | INTRA-CV % | INTER-CV % | |
| 1 (NEG) | 2.3 | 5.7 | 8.7 | 18.3 | 18.2 |
| 2 (NEG) | 3.9 | 5.8 | 10.3 | 12.4 | 13.2 |
| 3 (POS) | 50.5 | 3.1 | 5.0 | 1.8 | 5.4 |
| 4 (POS) | 29.0 | 4.3 | 4.4 | 5.3 | 9.4 |
| 5 (POS) | 79.6 | 2.7 | 4.5 | 2.1 | 3.5 |
| 6 (POS) | 103.1 | 1.8 | 3.6 | 4.7 | 6.1 |
| CAL | 106.0 | 5.4 | 7.3 | 3.3 | 6.7 |
| POS CTRL | 52.3 | 1.5 | 3.1 | 3.9 | 6.6 |
| NEG CTRL | 1.6 | 12.6 | 14.3 | 20.2 | 29.4 |
D. Crossreactivity
Twenty-four sera positive for the six autoimmune specificities were tested in Is- anti-Scl-70 Test Kit. The results are shown in Table 3.
| ﻧ
1
| • |
|---|
| ------------- |
| Table 3 Crossreactivity | |||
|---|---|---|---|
| Sample | Is-anti-Scl-70 EU/ml | Interp | Specificity |
| 1 | 7.2 | NEG | SSA |
| 2 | 3.7 | NEG | SSA |
| 3 | 1.5 | NEG | SSA |
| 4 | 3.0 | NEG | SSA |
| 5 | 4.0 | NEG | SSB |
| 6 | 2.6 | NEG | SSB |
| 7 | 3.1 | NEG | SSB |
| 8 | 3.6 | NEG | SSB |
| 9 | 3.0 | NEG | Sm |
| 10 | 3.2 | NEG | Sm |
| 11 | 2.5 | NEG | Sm |
| 12 | 4.1 | NEG | Sm |
| 13 | 4.4 | NEG | RNP |
| 14 | 3.0 | NEG | RNP |
| 15 | 4.2 | NEG | RNP |
| 16 | 4.7 | NEG | RNP |
| 17 | 3.3 | NEG | Jo-1 |
| 18 | 5.1 | NEG | Jo-1 |
| 19 | 1.9 | NEG | Jo-1 |
| 20 | 2.9 | NEG | Jo-1 |
| 21 | 134.2 | POS | Scl-70 |
| 22 | 108.0 | POS | Scl-70 |
| 23 | 110.1 | POS | Scl-70 |
| 24 | 165.6 | POS | Scl-70 |
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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 Sm results in the normal population performed manually and on MAGO respectively.
The distribution of EU/ml values for 50 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-Scl-70 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. There is a horizontal line at 20.0 on the y-axis, and a curve that increases from approximately 0.0 to 5.0, with one outlier at approximately 18.0.
Image /page/3/Figure/4 description: The image is a graph titled "Is-anti-Scl-70 Expected Values". The x-axis is labeled "Number of Sera" and ranges from 0 to 150. The y-axis is labeled "EU/ml" and ranges from 0.0 to 160.0. The graph shows a line that is relatively flat until the number of sera reaches approximately 140, at which point the line increases sharply.
Figure 3 Manual Normals
Image /page/3/Figure/6 description: The image shows a graph titled "Is-anti-Scl-70 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 approximately 20.0. There is also a line that starts near 0 and gradually increases to approximately 4.
Figure 4 Manual Expected Values
Image /page/3/Figure/8 description: The image is a graph titled "Is-anti-Sci-70 Expected Values". The x-axis is labeled "Number of Sera" and ranges from 0 to 150. The y-axis is labeled "EU/ml" and ranges from 0.0 to 140.0. The graph shows a horizontal line at approximately 18 EU/ml, and a curve that rises sharply after the number of sera reaches approximately 140.
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 150 samples in the Is-anti-Scl-70 Test Kit showed a correlation of 0.99 (Pearson).