(64 days)
Not Found
Not Found
No
The summary describes a standard enzyme-linked immunosorbent assay (EIA) for detecting antibodies. There is no mention of AI, ML, or any computational analysis beyond standard statistical calculations for performance metrics.
No
This device is an in vitro diagnostic (IVD) assay used to aid in the diagnosis of Systemic Lupus Erythematosus (SLE) by detecting antibodies. It does not provide treatment or therapy.
Yes
The "Intended Use / Indications for Use" section explicitly states that "The results of the assay are to be used as an aid in the diagnosis of Systemic Lupus Erythematosus (SLE)," which is a clear indication that its purpose is diagnostic in nature.
No
The device is an in vitro diagnostic (IVD) assay, which is a physical kit containing reagents and other materials for laboratory testing, not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's for "detecting antibodies in a single serum specimen" and "as an aid in the diagnosis of Systemic Lupus Erythematosus (SLE)." This clearly indicates it's used to examine specimens from the human body to provide information for diagnosis.
- Device Description: The description confirms it's an "enzyme-linked immunosorbent assay (EIA) for the detection and semi-quantitation of Immunoglobulin to dsDNA in human sera." This describes a laboratory test performed on a biological sample (serum).
- Input Imaging Modality: It's listed as "Not Applicable (In vitro diagnostic device)," which is consistent with a device that analyzes biological samples rather than images.
- Anatomical Site: It's listed as "Not Applicable (In vitro diagnostic device using serum)," further reinforcing its use with a biological sample.
All of these points align with the definition of an In Vitro Diagnostic device, which is a medical device intended for use in vitro for the examination of specimens derived from the human body solely or principally for the purpose of providing information concerning a physiological or pathological state, or concerning a congenital abnormality, or to determine the compatibility of tissues, organs or blood, or to monitor therapeutic measures.
N/A
Intended Use / Indications for Use
The assay is intended for use in detecting antibodies in a single serum specimen. The results of the assay are to be used as an aid in the diagnosis of Systemic Lupus Erythematosus (SLE).
Product codes
Not Found
Device Description
The dsDNA Immunoglobulin EIA test system is an enzyme-linked immunosorbent assay (EIA) for the detection and semi-quantitation of Immunoglobulin to dsDNA in human sera.
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
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
The dsDNA Immunoglobulin EIA Test System is substantially equivalent to the Clark ELISA for dsDNA IgG, IgM antibodies. Equivalence is demonstrated by the following comparative results:
A total of 133 patient specimens were obtained. Eighty-eight of the specimens were from normal individuals. The serum were evaluated relative to a forty-five specimens were thought to have autoimmune disease. commercially available dsDNA ELISA assay. The results were shown in Table 1.
The MarDx EIA was evaluated for precision by testing seven sera ten times each on three different days. The results are summarized in Table 2.
Key Metrics
Relative Sensitivity = 38/40 = 95.0%
Relative Specificity = 81/81 = 100%
Relative Accuracy = 119/121 = 98.3%
Predicate Device(s)
Clark ELISA for dsDNA IgG, IgM antibodies
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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
Image /page/0/Picture/0 description: The image shows the logo for "MarDx" in a bold, sans-serif font. The letters "MaR" are in black, with the "D" and "X" also in black. To the right of the logo, the number "591" is visible, suggesting it might be part of an address or identification code. The overall impression is of a professional and established brand.
Diagnostics, Inc., 5919 Farnsworth Ct, Carlsbad, CA 92008 • 800-331 -2291 • CA: 619-929-0500 • FAX: 619-929-0124
MAR 2 0 1996
510(k) Summary of Safety and Effectiveness Information dsDNA EIA Test System K91,0182
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and proposed 21 CFR Part 807.92.
Identification of predicate device:
The dsDNA Immunoglobulin ElA test system is substantially equivalent to the Clark ELISA for dsDNA IgG, IgM antibodies.
Description of New Device
The dsDNA Immunoglobulin EIA test system is an enzyme-linked immunosorbent assay (EIA) for the detection and semi-quantitation of Immunoglobulin to dsDNA in human sera.
atement of the intended use:
The assay is intended for use in detecting antibodies in a single serum specimen. The results of the assay are to be used as an aid in the diagnosis of Systemic Lupus Erythematosus (SLE).
Technological characteristics of the device:
The dsDNA Immunoglobulin ElA test system is an enzyme linked immunosorbent assay to detect Immunoglobulin, to dsDNA. Purified dsDNA antigens are attached to a solid phase microtiter well. Diluted test sera is added to each well. If the antibodies are present that recognize the antigen, they will bind to the antigen in the well. After incubation the wells are washed to remove unbound antibody. An enzyme labeled antihuman Immunoglobulin is added to each well. If antibody is present it will bind to the antibody attached to the antigen on well. After incubation, the wells are washed to remove unbound conjugate. A substrate solution is added to each well. If enzyme is present, the substrate will undergo a color change. After an incubation period, the reaction is stopped and the color intensity is measured photometrically, producing an indirect measurement of specific antibody in the patient specimen
Description and conclusions of the clinical studies:
The dsDNA Immunoglobulin EIA Test System is substantially equivalent to the Clark ELISA for dsDNA IgG, IgM antibodies. Equivalence is demonstrated by the following comparative results:
1
total of 133 patient specimens were obtained. Eighty-eight of the specimens were from normal individuals. The serum were evaluated relative to a orty-five specimens were thought to have autoimmune disease. commercially available dsDNA ELISA assay. The results were shown in Table 1.
Table 1 Sensitivity and Specificity of the MarDx dsDNA EIA relative to Clark dsDNA test
MarDx dsDNA EIA
| + | eq | - | Total | ||
|---|---|---|---|---|---|
| + | 38 | 7 | 2* | 47 | |
| Alternate | |||||
| EIA eq | 0 | 0 | 2 | 2 | |
| - | 0 | 3 | 81 | 84 | |
| Total | 38 | 10 | 85 | 133 |
Carrent
ાં જિલ્લ
Kennelik
Sera falling in the equivocal range were not included in the following calculations.
These 2 sera were tested by Crithidia IFA and found to be negative.
| Relative Sensitivity | = 38/40 | = 95.0% |
|---|---|---|
| Relative Specificity | = 81/81 | = 100% |
| Relative Accuracy | = 119/121 | = 98.3% |
The MarDx EIA was evaluated for precision by testing seven sera ten times each on three different days. The results are summarized in Table 2.
Table 2 Precision of the MarDx EIA Test
| Assay 1 (n=10) | Assay 2 (n=10) | Assay 3 (n=10) | Inter Assay (n=30) | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| X | SD | CV | X | SD | CV | X | SD | CV | X | SD | CV |
| 7.78 | 0.252 | 3.24% | 8.10 | 0.329 | 4.06% | 7.31 | 0.237 | 3.24% | 7.73 | 0.424 | 5.48% |
| 8.07 | 0.188 | 2.32% | 8.48 | 0.306 | 3.61% | 7.77 | 0.222 | 2.88% | 8.11 | 0.379 | 4.67% |
| 4.78 | 0.324 | 6.78% | 4.78 | 0.390 | 8.15% | 4.37 | 0.272 | 6.22% | 4.64 | 0.376 | 8.11% |
| 3.77 | 0.260 | 6.90% | 3.85 | 0.213 | 5.53% | 3.81 | 0.213 | 5.59% | 3.81 | 0.224 | 5.87% |
| 4.42 | 0.295 | 6.67% | 4.16 | 0.274 | 6.58% | 3.91 | 0.254 | 6.50% | 4.17 | 0.340 | 8.14% |
| 0.78 | 0.122 | 15.70% | 0.70 | 0.094 | 13.43% | 0.62 | 0.101 | 16.29% | 0.70 | 0.123 | 17.52% |
| 0.54 | 0.073 | 13.50% | 0.50 | 0.065 | 12.94% | 0.39 | 0.037 | 9.49% | 0.48 | 0.085 | 17.78% |
2
Table 3 Linearity
| Serum Serum | ﯿ | ||||
|---|---|---|---|---|---|
| 0.75 | 0.975 | ||||
| 3.92 | 0.989 | ||||
| 3.82 | 0.982 | ||||
| 0.981 | |||||
| 0.959 | |||||
| Neat Neat Neat | |||||
| 4.20 - | |||||
| 6.94 | |||||
| 7.36 | |||||
| 6.43 - | |||||
| 7.18 - | 1:2 | ||||
| 2.77 | |||||
| 5.31 - | |||||
| 5.39 - | |||||
| 4.67 - | 1:4 | ||||
| 1.50 ------------------------------------------------------------------------------------------------------------------------------------------------------------------------- | |||||
| 3.21 | |||||
| 5.42 | 1:8 - | ||||
| 2.33 - | |||||
| 2.10 - | |||||
| 1.89 - - | |||||
| 2.51 ------------------------------------------------------------------------------------------------------------------------------------------------------------------------- | 1:16 | ||||
| 1.24 0.73 | |||||
| 1.13 | |||||
| 1.05 | |||||
| 0.59 | |||||
| 1.48 |
Linear regression compared dsDNA Index Value to log2 of dilution.
Table 4 Cross Reactivity
| Serum # | Index Value | Interpretation | Specificity |
|---|---|---|---|
| 1. | 0.28 | - | Ro |
| 2. | 0.52 | - | Ro |
| 3. | 0.74 | - | Ro |
| 4. | 0.53 | - | La |
| 5. | 0.28 | - | La |
| 6. | 0.70 | - | La |
| 7. | 0.64 | - | SM |
| 8. | 0.90 | equ | SM |
| 9. | 0.72 | - | SM |
| 10. | 0.58 | - | RNP |
| 11. | 0.40 | - | RNP |
| 12. | 0.82 | equ | RNP |
| 13. | 0.79 | - | SCL-70 |
| 14. | 0.70 | - | SCL-70 |
| 15. | 0.46 | - | SCL-70 |
| 16. | 0.25 | - | Jo-1 |
| 17. | 0.63 | - | Jo-1 |
| 18. | 0.76 | - | Jo-1 |
ﺍﻟﻘﻠﻴﺴﻴﺔ ﺍﻟﻤﺴﺘﻮﻯ
3
Table 5 International Unit Conversion
| International Unit Standard
| Units / mL | Index Value |
|---|---|
| 200 | 4.20 |
| 100 | 2.37 |
| 50 | 1.50 |
| 25 | 0.75 |
Linear regression compared Index Value versus log International Units r = 0.975
Regression Equation Calculation
I.U. = 10° Y = Xa+b