(77 days)
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No
The device description and performance studies describe a standard ELISA test kit, which does not involve AI/ML. There are no mentions of AI, ML, or related concepts in the summary.
No
The device is an in vitro diagnostic (IVD) test used to detect antibodies for aid in diagnosis, not to treat or cure a disease.
Yes
The "Intended Use / Indications for Use" section states that "The results of the assay are to be used as an aid in the diagnosis of autoimmune disorders." This directly indicates its role in diagnosis.
No
The device is an ELISA test kit, which is a laboratory-based in vitro diagnostic device involving chemical reagents and physical components, not solely software.
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 Sm/RNP antigen in a single human serum sample" and the results are to be 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 confirms it's an "enzyme-linked immunosorbent assay (ELISA) for the detection and semi-quantitation of IgG to Sm/RNP antigen in human serum." ELISA is a common in vitro diagnostic technique.
- Sample Type: The test uses "human serum," which is a biological specimen from the human body.
All these points 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 Sm/RNP 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
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Device Description
The Is-anti-Sm/RNP Test Kit System is an enzyme-linked immunosorbent assay (ELISA) for the detection and semi-quantitation of IgG to Sm/RNP 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
A. Comparison Testing: 100 sera from normal blood donors and 50 sera from autoimmune patients.
F. Correlation of Manual and MAGO Results: 150 samples in the Is-anti-Sm/RNP Test Kit.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
A. Comparison Testing: The Diamedix Is-anti-Sm/RNP Test Kit was evaluated relative to another commercially available anti-Sm/RNP ELISA test kit using 100 sera from normal blood donors and 50 sera from autoimmune patients.
- Relative Sensitivity: Manual 88% (46/52), MAGO 90% (46/51)
- Relative Specificity: Manual 100% (97/97), MAGO 100% (97/97)
- Agreement: Manual 96% (143/149), MAGO 97% (143/148)
B. Linearity: Figures 1 and 2 show typical examples of Is-anti-Sm/RNP Test Kit linearity. The figures depict the results of the Calibrator tested by Is-anti-Sm/RNP 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-Sm/RNP Test Kit throughout the testing range.
C. Precision Testing: The precision of the Is-anti-Sm/RNP Test Kit was determined at Diamedix by testing six different sera and the Calibrator and controls over multiple days. Intra- and interassay precision data is provided for manual and MAGO methods.
D. Crossreactivity: Twenty-four sera positive for six autoimmune specificities were tested in Is-anti-Sm/RNP Test Kit. The device showed negative results for SSA, SSB, Jo-I, and Scl-70 specificities, and positive results for Sm and RNP specificities.
E. Expected Values: 100 normal donor sera were assayed. The distribution of EU/mI 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.
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-Sm/RNP Test Kit showed a correlation of 0.99 (Pearson).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Relative Sensitivity: Manual 88%, MAGO 90%
Relative Specificity: Manual 100%, MAGO 100%
Agreement: Manual 96%, MAGO 97%
Correlation of Manual and MAGO Results: 0.99 (Pearson)
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-Sm/RNP 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).
0
APR - 8 1997
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 |
|---|---|
| Phone Number: | 305-324-2354 |
| Fax Number: | 305-324-2585 |
Device Information:
| Trade Name: | Is-(immunosimplicity)-anti-Sm/RNP Test System |
|---|---|
| Common Name: | Anti-Sm/RNP EIA Test |
| Classification Name: | Extractable Antinuclear Antibody |
Equivalent Device:
Helix Diagnostics Enzyme Immunoassay Anti-Sm/RNP Antibody Test Kit
Device Description: The Is-anti-Sm/RNP Test Kit System is an enzyme-linked immunosorbent assay (ELISA) for the detection and semi-quantitation of IgG to Sm/RNP antigen in human serum.
Intended use: The assay is intended for use in detecting antibodies to Sm/RNP 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-Sm/RNP Test System is an enzyme-linked immunosorbent assay to detect IgG to Sm/RNP in human serum. Purified Sm/RNP antigen is attached to a solid phase microtiter well. Diluted test sera are added to each well. If antibodies which recognize the Sm/RNP 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.
1
Summary of Safety and Effectiveness
Performance Characteristics
A. Comparison Testing
The Diamedix Is-anti-Sm/RNP Test Kit was evaluated relative to another commercially available anti-Sm/RNP ELISA test kit using 100 sera from normal blood donors and 50 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 | 46/52 | 88 | 77-96 | 46/51 | 90 | 79/97 |
| Relative | ||||||
| Specificity | 97/97 | 100 | 96-100 | 97/97 | 100 | 96-100 |
| Agreement | 143/149* | 96 | 91-99 | 143/148** | 97 | 91-99 |
- One borderline sample was excluded from the calculations.
** Two samples, one equivocal and one borderline, were excluded from the calculations.
Six sera negative by Is-anti-Sm/RNP (manual) and positive by the comparative method were negative when tested by a third method. Five sera negative by Is-anti-Sm/RNP (MAGO) and positive by the comparative method were negative by a third method.
B. Linearity
Figures 1 and 2 show typical examples of Is-anti-Sm/RNP Test Kit linearity. The figures depict the results of the Calibrator tested by Is-anti-Sm/RNP 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-Sm/RNP Test Kit throughout the testing range.
Image /page/1/Figure/10 description: The image is a graph titled "Is anti-Sm/RNP Calibrator Linearity". The x-axis is labeled "Dilution" and ranges from 0.0 to 1.0. The y-axis is labeled "Absorbance" and ranges from 0.0 to 2.0. The graph shows a linear relationship with an R-squared value of 0.985.
Figure 1 Manual Linearity
Image /page/1/Figure/12 description: The image is a graph titled "Is anti-Sm/RNP Calibrator Linearity". The graph shows the relationship between dilution and absorbance. The R-squared value is 0.9419, indicating a strong correlation. The x-axis represents dilution, ranging from 0.0 to 1.0, while the y-axis represents absorbance, ranging from 0.0 to 2.0.
Figure 2 MAGO Linearity
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C. Precision Testing
The precision of the Is-anti-Sm/RNP Test Kit was determined at Diamedix by testing six different sera and The precision of the Is-anti-Shirtin Tost Itif Frent days. The intra- and interassay precision is shown in Table 2 below.
| Table 2 | anti-Sm/RNP PRECISION | ||||
|---|---|---|---|---|---|
| Overall | MANUAL | MAGO | |||
| SERUM | MEAN EU/ml | INTRA-CV% | INTER-CV% | INTRA-CV % | INTER-CV % |
| 1 (NEG) | 1.9 | 8.8 | 13.3 | 15.4 | 13.0 |
| 2 (NEG) | 1.8 | 7.3 | 6.3 | 10.9 | 10.5 |
| 3 (POS) | 26.1 | 3.5 | 4.5 | 5.9 | 9.8 |
| 4 (POS) | 47.0 | 5.6 | 6.0 | 7.8 | 9.8 |
| 5 (POS) | 81.9 | 2.8 | 6.1 | 5.5 | 7.1 |
| 6 (POS) | 108.6 | 3.1 | 5.4 | 3.7 | 7.1 |
| CAL | 100.4 | 3.5 | 5.8 | 4.3 | 4.6 |
| POS CTRL | 46.3 | 3.3 | 6.5 | 6.6 | 8.7 |
| NEG CTRL | 1.0 | 13.4 | 20.0 | 34.6 | 30.0 |
D. Crossreactivity
Twenty-four sera positive for the six autoimmune specificities were tested in Is- anti-Sm/RNP Test Kit. The results are shown in Table 3.
| 1 |
|---|
| œ |
| Samp | Is anti-Sm/RNP | Interp | Specificity |
|---|---|---|---|
| 1 | ર્ર રે | NEG | SSA |
| 2 | 5.3 | NEG | SSA |
| 3 | 2.3 | NEG | SSA |
| 4 | 3.9 | NEG | SSA |
| 5 | 7.9 | NEG | ਟ ਡੈਡ |
| 6 | 6.2 | NEG | SSB |
| 7 | 3.9 | NEG | SBB |
| 8 | 2.0 | NEG | SSB |
| 9 | ારરી તે | POS | Sm |
| 10 | ા રહ્યા | POS | Sm |
| 11 | 129.0 | POS | Sm |
| 12 | 135.9 | POS | Sm |
| 13 | 156.2 | POS | RNP |
| 14 | 156.6 | POS | RNP |
| 15 | 156.8 | POS | RNP |
| 1 Q | 156.0 | POS | RNP |
| 17 | 2.2 | NEG | Jo- I |
| 18 | 3.4 | NEG | Jo- 1 |
| 19 | 1.9 | NEG | Jo- l |
| 20 | 2.5 | NEG | Jo-1 |
| 21 | 3.6 | NEG | Scl-70 |
| 22 | 2.0 | NEG | Scl-70 |
| 23 | 2.4 | NEG | Scl-70 |
| 24 | 1.2 | NEG | Sci-70 |
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 The Expected values in the Renies 3 and 5 show the distribution of Sm/RNP results in the normal population performed manually and on MAGO respectively.
The distribution of EU/mI 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-Sm/RNP 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 approximately 20.0 EU/ml, and a curve that starts near 0.0 and increases to approximately 17.0 at the end of the x-axis.
Image /page/3/Figure/4 description: The image shows the title of a figure. The title is "Figure 3 Manual Normals". The text is in bold font.
Image /page/3/Figure/5 description: The image is a graph titled "ls-anti-Sm/RNP". 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 200.0. The graph shows a line that is relatively flat until the x value is approximately 100, then the line increases sharply until the x value is approximately 140, then the line flattens out again.
Figure 4 Manual Expected Values
Image /page/3/Figure/7 description: The image contains two line plots comparing EU/ml to the number of sera. The plot on the left is titled "Is-anti-Sm/RNP Normals", and the plot on the right is titled "Is-anti-Sm/RNP Expected Values". The left plot shows the number of sera ranging from 0 to 100, and the EU/ml ranges from 0 to 30. The right plot shows the number of sera ranging from 0 to 150, and the EU/ml ranges from 0 to 250.
Figure 5 MAGO Normals
Image /page/3/Figure/9 description: The image shows the text "Figure 6 MAGO Expected Values". The text is in bold font. The text is centered in the image.
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-Sm/RNP Test Kit showed a correlation of 0.99 (Pearson).