(77 days)
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No
The device description and performance studies indicate a standard ELISA assay, with no mention of AI/ML terms or methodologies.
No
The device is an in vitro diagnostic assay used as an aid in diagnosing autoimmune disorders, not for treating them.
Yes
The assay results are explicitly stated to be "used as an aid in the diagnosis of autoimmune disorders," indicating its diagnostic purpose.
No
The device description explicitly states it is an "enzyme-linked immunosorbent assay (ELISA) for the detection and semi-quantitation of IgG to Sm antigen in human serum," which is a laboratory test kit involving physical reagents and procedures, not 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 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 Sm antigen in human serum." This confirms it's a test performed in vitro (outside the body) on a human specimen (serum).
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 Sm 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 Test Kit System is an enzyme-linked immunosorbent assay (ELISA) for the detection and semi-quantitation of IgG to Sm 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:
Sample Size: 100 sera from normal blood donors and 50 sera from autoimmune patients.
Results (Manual): Relative Sensitivity 87% (34/39), Relative Specificity 100% (107/107), Agreement 97% (141/146).
Results (MAGO): Relative Sensitivity 85% (35/41), Relative Specificity 100% (107/107), Agreement 96% (142/148).
Key results: For the manual method, two equivocal and two borderline samples were excluded. For the MAGO method, two borderline samples were excluded. Five sera negative by Is-anti-Sm (manual) and positive by the comparative method were negative when tested by a third method. Six sera negative by Is-anti-Sm (MAGO) and positive by the comparative method were negative when tested by a third method. All discordant sera were from patient samples.
Linearity:
Study Type: Serial two-fold manual dilutions of Calibrator in Sample Diluent.
Results: Manual Linearity R-squared value of 0.9949. MAGO Linearity R-squared value of 0.9879.
Key results: The results demonstrate a high degree of linearity for Is-anti-Sm Test Kit throughout the testing range.
Precision Testing:
Study Type: Intra- and interassay precision determination by testing six different sera and kit controls on three different days.
Key results: Table 2 shows INTRA-CV% and INTER-CV% for manual and MAGO methods across various serum samples (negative and positive) and controls (Calibrator, Positive Control, Negative Control). CV percentages ranged from 2.8% to 25.0% for manual, and 2.1% to 50.0% for MAGO.
Crossreactivity:
Sample Size: Twenty-four sera positive for six autoimmune specificities.
Key results: Table 3 shows the interpretation (POS/NEG) for Is-anti-Sm Test Kit for samples known to be positive for SSA, SSB, Sm, RNP, Jo-1, and Scl-70. Only samples with Sm specificity tested positive (78.2, 66.4, 103.6, 103.1), while others tested negative (Is anti-Sm values ranging from 1.3 to 10.2).
Expected Values:
Sample Size: 100 normal donor sera collected in South Florida, and 50 clinically characterized sera.
Key results: Figures 3 and 5 show the distribution of Sm results in the normal population performed manually and on MAGO respectively. Figures 4 and 6 show the distribution of EU/ml values for 50 clinically characterized sera along with the 100 normal donor sera performed manually and on MAGO respectively.
Correlation of Manual and MAGO Results:
Sample Size: 150 samples.
Key results: Numerical comparison of EU/ml values showed a correlation of 0.99 (Pearson).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Relative Sensitivity (Manual): 87%
Relative Specificity (Manual): 100%
Agreement (Manual): 97%
Relative Sensitivity (MAGO): 85%
Relative Specificity (MAGO): 100%
Agreement (MAGO): 96%
Pearson correlation between manual and MAGO results: 0.99
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.
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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 |
Device Information:
Fax Number:
Trade Name: Is-(immunosimplicity)-anti-Sm Test System Common Name: Anti-Sm EIA Test Classification Name: Extractable Antinuclear Antibody
305-324-2585
Equivalent Device:
Helix Diagnostics Enzyme Immunoassay Anti-Sm Antibody Test Kit
Device Description: The Is-anti-Sm Test Kit System is an enzyme-linked immunosorbent assay (ELISA) for the detection and semi-quantitation of IgG to Sm antigen in human serum.
Intended use: The assay is intended for use in detecting antibodies to Sm 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 Test System is an enzyme-linked immunosorbent assay to detect IgG to Sm antigen in human serum. Purified Sm antigen is attached to a solid phase microtiter well. Diluted test sera are added to each well. If antibodies which recognize the Sm 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-Sm Test Kit was evaluated relative to another commercially available anti-Sm 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 | 34/39 | 87 | 73-96 | 35/41 | 85 | 71-94 |
| Relative | ||||||
| Specificity | 107/107 | 100 | 97-100 | 107/107 | 100 | 97-100 |
| Agreement | 141/146* | 97 | 92-99 | 142/148** | 96 | 92-99 |
- Two equivocal and two borderline samples were excluded from the calculations.
** Two borderline samples were excluded from the calculations.
Five sera negative by Is-anti-Sm (manual) and positive by the comparative method were negative when tested by a third method. Six sera negative by Is-anti-Sm (MAGO) and positive by the comparative method were negative when tested by a third method. All discordant sera were from patient samples.
B. Linearity
Figures 1 and 2 show typical examples of Is-anti-Sm Test Kit linearity. The figures depict the results of the Calibrator tested by Is-anti-Sm 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 Is-anti-Sm Test Kit throughout the testing range.
Image /page/1/Figure/10 description: The image contains two graphs titled "Is anti-Sm Calibrator Linearity". Both graphs show the relationship between absorbance and dilution. The graph on the left is labeled "Figure 1 Manual Linearity" and has an R-squared value of 0.9949, while the graph on the right is labeled "Figure 2 MAGO Linearity" and has an R-squared value of 0.9879.
Figure 1 Manual Linearity
Image /page/1/Figure/12 description: The image shows the text "Figure 2 MAGO Linearity". The text is in black font and is centered in the image. The text is likely a title or caption for a figure in a document. The figure is likely related to the linearity of MAGO, which may be a chemical compound or a process.
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C. Precision Testing
The precision of the Is-anti-Sm Test Kit was determined at Diamedix by testing six different sera and kit The precision of the in and con-res on three different days. The intra- and interassay precision is shown in Table 2 below.
| Table 2 | Z anti-Sm PRECISION | ||||
|---|---|---|---|---|---|
| Overall | |||||
| MEAN EU/ml | MANUAL | MAGO | |||
| SERUM | INTRA-CV% | INTER-CV% | INTRA-CV % | INTER-CV % | |
| 1 (NEG) | 1.6 | 8.2 | 7.1 | 19.7 | 23.5 |
| 2 (NEG) | 1.6 | 9.2 | 25.0 | 10.2 | 13.3 |
| 3 (POS) | 56.0 | 3.2 | 3.5 | 3.9 | 4.5 |
| 4 (POS) | 38.4 | 5.5 | 5.7 | 3.4 | 7.9 |
| 5 (POS) | 80.7 | 3.9 | 4.6 | 2.1 | 3.4 |
| 6 (POS) | 93.9 | 2.8 | 3.6 | 2.7 | 5.3 |
| CAL | 104.3 | 2.8 | 4.2 | 3.7 | 6.7 |
| POS CTRL | 52.6 | 3.1 | 4.2 | 5.2 | 7.6 |
| NEG CTRL | 0.8 | 12.1 | 25.0 | 47.2 | 50.0 |
D. Crossreactivity
Twenty-four sera positive for the six autoimmune specificities were tested in Is- anti-Sm Test Kit. The results afe shown in Table 3.
| Sample | Is anti-Sm | Interp | Specificity |
|---|---|---|---|
| 1 | 2.2 | NEG | SSA |
| 2 | 2.6 | NEG | SSA |
| 3 | 1.4 | NEG | SSA |
| 4 | 1.3 | NEG | SSA |
| 5 | 2.0 | NEG | SSB |
| 6 | 2.2 | NEG | SSB |
| 7 | 2.1 | NEG | SSB |
| 8 | 1.5 | NEG | SSB |
| 9 | 78.2 | POS | Sm |
| 10 | 66.4 | POS | Sm |
| 11 | 103.6 | POS | Sm |
| 12 | 103.1 | POS | Sm |
| 13 | 7.1 | NEG | RNP |
| 14 | 3.8 | NEG | RNP |
| 15 | 10.2 | NEG | RNP |
| 16 | 2.1 | NEG | RNP |
| 17 | 2.8 | NEG | Jo-1 |
| 18 | 4.0 | NEG | Jo-1 |
| 19 | 3.4 | NEG | Jo-1 |
| 20 | 2.6 | NEG | Jo-1 |
| 21 | 1.6 | NEG | Scl-70 |
| 22 | 2.0 | NEG | Scl-70 |
| 23 | 2.3 | NEG | Scl-70 |
| 24 | 1.9 | NEG | Scl-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 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-Sm 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 and a curve that starts near 0.0 and increases to approximately 14.0 at the end of the graph.
Image /page/3/Figure/4 description: The image is a graph titled "Is-anti-Sm 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 200.0. The graph shows a line that is relatively flat until around 100, then it increases sharply.
Figure 3 Manual Normals
Image /page/3/Figure/6 description: The image is a graph titled "Is-anti-Sm 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 gradually increases to approximately 5.0 at the end of the x-axis.
Figure 5 MAGO Normals
Figure 4 Manual Expected Values
Image /page/3/Figure/9 description: This image is a graph titled "Is-anti-Sm 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 180.0. There is a horizontal line at approximately 20.0 on the y-axis, and a curve that starts near 0 and increases sharply after 100 on the x-axis.
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-Sm Test Kit showed a correlation of 0.99 (Pearson).