(130 days)
Not Found
Not Found
No
The device description and performance studies describe a standard enzyme-linked immunosorbent assay (EIA) and do not mention any AI or ML components.
No
The device is described as an aid in diagnosis and does not treat or prevent disease.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states that the device is "as an aid in the diagnosis of autoimmune disease".
No
The device description clearly states it is an enzyme-linked immunosorbent assay (EIA), which is a laboratory test method involving physical reagents and processes, 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 is "intended for use in testing human serum for the presence of human IgG to extractable nuclear antigens, as an aid in the diagnosis of autoimmune disease". This involves testing a sample taken from the human body in vitro (outside the body) to provide information for diagnosis.
- Device Description: The description confirms it is an "enzyme-linked immunosorbent assay (ElA) for the detection of IgG to extractable nuclear antigens in human serum". This is a common type of laboratory test performed on biological samples.
These points clearly align with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The MarDx ENA IgG ImmunoStripe Test System is intended for use in testing human serum for the presence of human IgG to extractable nuclear antigens, as an aid in the diagnosis of autoimmune disease, such as systemic lupus erythematosus. Siogren syndrome, scieroderma, and myositis.
Product codes (comma separated list FDA assigned to the subject device)
Not Found
Device Description
The MarDx ENA IgG Immunostripe Test System is an enzyme-linked immunosorbent assay (ElA) for the detection of IgG to extractable nuclear antigens in human serum.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
The MarDx ENA IgG Immunostripe Test System is substantially equivalent to the INOVA ENA EIA's for SSA, SSB, Sm, RNP, Jo-1, Scl-70 and the MarDx ENA EIA 6 in 1 Test System for the detection of immunoglobulin to SSA, SSB, Sm, RNP, Jo-1, Scl-70 in human serum. Equivalence is demonstrated by the following comparative results:
Two hundred and sixty four sera were tested by EIA (INOVA ELISA for ENA antibodies), and the MarDx 6 in 1 ENA EIA, to determine the relative sensitivity and specificity of the MarDx ENA IgG Immunostripe test kit. One hundred and thirty-nine of the sera were from normal individuals which should not have antibodies to ENA antigens. One hundred and twenty five sera were from patients thought to have autoimmune disease and submitted as blind specimens for ENA antigen detection. The MarDx and INOVA assays were performed by the R&D laboratory at MarDx following manufacturer's package insert. Assay sensitivity ranged from 89 to 100%, specificity was 100%. The raw data from the study is prepared in Attachment 5. The data is summarized in Tables 1-11.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Specificity of the MarDx ENA IgG Immunostripe Test System relative to the INOVA EIA Test Systems (40/40) = 100% Specificity.
Specificity of the MarDx ENA IgG Immunostripe Test System relative to the MarDx 6 in 1 ENA EIA Test System (139/139) = 100% Specificity.
Sensitivity of the MarDx ENA IgG Immunostripe Test System relative to the INOVA SSA EIA Test System: SSA Sensitivity (35/37) = 95%.
Sensitivity of the MarDx ENA IgG Immunostripe Test System relative to the INOVA SSB EIA Test System: SSB Sensitivity (16/17) = 94%.
Sensitivity of the MarDx ENA IgG Immunostripe Test System relative to the INOVA Sm EIA Test System: Sm Sensitivity (20/20)= 100%.
Sensitivity of the MarDx ENA IgG Immunostripe Test System relative to the INOVA RNP EIA Test System: RNP Sensitivity (33/37) = 89%.
Sensitivity of the MarDx ENA IgG Immunostripe Test System relative to the INOVA Jo-1 ElA Test System: Jo-1 Sensitivity (2/2)= 100%.
Sensitivity of the MarDx ENA IgG Immunostripe Test System relative to the INOVA Scl-70 ElA Test System: Scl-70 Sensitivity (7/7)= 100%.
INOVA SUMMARY Sensitivity of the MarDx ENA IgG Immunostripe Test System relative to the Six Combined Results from the INOVA ENA EIA Test Systems: Sensitivity (113/120) = 94%.
Sensitivity of the MarDx ENA IgG Immunostripe Test System relative to the MarDx 6 in 1 ENA EIA Test System: Sensitivity (67/69) = 97%.
Precision Study: Precision = 100%.
Cross-Reactivity Study: Cross Reactivity to dsDNA = 0%.
Summary Table For All Data:
| MarDx Immunostripe | Reference Manufacturer | Number of Specimens | Reference | Sensitivity | Specificity |
|---|---|---|---|---|---|
| Immunostripe | vs INOVA | 35/37 | SSA | 95% | NA |
| Immunostripe | vs INOVA | 16/17 | SSB | 94% | NA |
| Immunostripe | vs INOVA | 20/20 | Sm | 100% | NA |
| Immunostripe | vs INOVA | 33/37 | RNP | 89% | NA |
| Immunostripe | vs INOVA | 2/2 | Jo-1 | 100% | NA |
| Immunostripe | vs INOVA | 7/7 | Scl-70 | 100% | NA |
| Immunostripe | vs INOVA | 40/40 | Normals | NA | 100% |
| Immunostripe | vs MarDx | 67/69 | 6 in 1 | 97% | NA |
| Immunostripe | vs MarDx | 139/139 | Normals | NA | 100% |
| Immunostripe | Combined Sensitivity and Specificity | 95% | 100% |
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.
The MarDx ENA IgG Immunostripe Test System is substantially equivalent to the INOVA ENA's for SSA, SSB. Sm. RNP. Jo-1, Scl-70 and the MarDx ENA EIA 6 in 1 Test System for the detection of immunoglobulin to SSA, SSB, Sm, RNP, Jo-1, Scl-70 in human serum.
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.
Not Found
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).
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
ATTACHMENT 1 - 510K Summary
APR -8 1997
510(k) Summary of Safety and Effectiveness Information MarDx ENA IgG Immunostripe Test System
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.
ldentification of Predicate Devices:
The MarDx ENA IgG Immunostripe Test System is substantially equivalent to the INOVA ENA's for SSA, SSB. Sm. RNP. Jo-1, Scl-70 and the MarDx ENA EIA 6 in 1 Test System for the detection of immunoglobulin to SSA, SSB, Sm, RNP, Jo-1, Scl-70 in human serum.
Description of New Device:
The MarDx ENA IgG Immunostripe Test System is an enzyme-linked immunosorbent assay (ElA) for the detection of IgG to extractable nuclear antigens in human serum.
Statement of Intended Use:
The MarDx ENA IgG ImmunoStripe Test System is intended for use in testing human serum for the presence of human IgG to extractable nuclear antigens, as an aid in the diagnosis of autoimmune disease, such as systemic lupus erythematosus. Siogren syndrome, scieroderma, and myositis.
Technological Characteristics of the Device:
The MarDx ENA IgG Immunostripe Test System is an enzyme linked immunosorbent assay to detect IgG, to SSA, SSB, Sm, RNP, Jo-1, Scl-70. Purfiled antigens are individually attached to specific locations on a solid phase support, nitrocellulose. Diluted test sera is added to a well containing the Immunostripe strip. If the antibodies are present that recognize an antigen, they will bind to the antigen present on the strip. After incubation the nitrocellulose strip is washed to remove unbound antibody. An enzyme labeled antihuman IgG is added to each strip. If antibody is present the conjugate will bind to the antibody attached to the specific antigens. The strip is washed to remove unbound coniugate and a substrate solution is then added. If the enzyme/antibody complex is present, the substrate will undergo a precipitation and color change. After an incubation period, the reaction is stopped and the presence of precipitated substrate is visualized at specific locations on the strip. The presence of a colored precipitation at pre-determined locations on the Immunostripe strip is an indirect measurement of specific antibody for SSA, SSB, Sm, RNP, Jo-1, Scl-70 in the patient specimen.
Description and Conclusions of the Clinical Studies.
The MarDx ENA IgG Immunostripe Test System is substantially equivalent to the INOVA ENA EIA's for SSA, SSB, Sm, RNP, Jo-1, Scl-70 and the MarDx ENA EIA 6 in 1 Test System for the detection of immunoglobulin to SSA, SSB, Sm, RNP, Jo-1, Scl-70 in human serum. Equivalence is demonstrated by the following comparative results:
1
Two hundred and sixty four sera were tested by EIA (INOVA ELISA for ENA antibodies), and the MarDx 6 in 1 ENA EIA, to determine the relative sensitivity and specificity of the MarDx ENA IgG Immunostripe test kit. One hundred and thirty-nine of the sera were from normal individuals which should not have antibodies to ENA antigens. One hundred and twenty five sera were from patients thought to have autoimmune disease and submitted as blind specimens for ENA antigen detection. The MarDx and INOVA assays were performed by the R&D laboratory at MarDx following manufacturer's package insert. Assay sensitivity ranged from 89 to 100%, specificity was 100%. The raw data from the study is prepared in Attachment 5. The data is summarized in Tables 1-11.
| Table 1 |
|---|
| Specificity of the MarDx ENA IgG Immunostripe Test System |
| relative to the INOVA EIA Test Systems |
| INOVA EIA | ||||
|---|---|---|---|---|
| Positive | Negative | Total | ||
| MarDx | Positive | 0 | 0 | 0 |
| Immunostripe | Negative | 0 | 40 | 40 |
| Total | 0 | 40 | 40 |
(40/40) = 100% Specificity
| Table 2 |
|---|
| Specificity of the MarDx ENA IgG Immunostripe Test System |
| relative to the MarDx 6 in 1 ENA ElA Test System |
| MarDx 6 in 1 ENA EIA | ||||
|---|---|---|---|---|
| Positive | Negative | Total | ||
| MarDx | ||||
| Immunostripe | Positive | 0 | 0 | 0 |
| Negative | 0 | 139 | 139 | |
| Total | 0 | 139 | 139 |
Specificity (139/139) = 100%
Table 3
Sensitivity of the MarDx ENA IgG Immunostripe Test System relative to the INOVA SSA EIA Test System
| Antigen: SSA | INOVA SSA EIA | |||
|---|---|---|---|---|
| Positive | Negative | Total | ||
| MarDx | Positive | 35 | 0 | 35 |
| Immunostripe | Negative | 2 | 0 | 2 |
| Total | 37 | 0 | 37 |
SSA Sensitivity (35/37) = 95%
2
Table 4 Sensitivity of the MarDx ENA IgG Immunostripe Test System relative to the INOVA SSB EIA Test System
| Antigen: SSB | INOVA SSB EIA | |||
|---|---|---|---|---|
| Positive | Negative | Total | ||
| MarDx | Positive | 16 | 0 | 16 |
| Immunostripe | ||||
| Negative | 1 | 0 | 1 | |
| Total | 17 | 0 | 17 |
SSB Sensitivity (16/17) = 94%
| Table 5 | |||
|---|---|---|---|
| Sensitivity of the MarDx ENA IgG Immunostripe Test System | |||
| relative to the INOVA Sm EIA Test System |
| Antigen: Sm | INOVA Sm EIA | |||
|---|---|---|---|---|
| Positive | Negative | Total | ||
| MarDx | Positive | 20 | 1 | 21 |
| Immunostripe | ||||
| Negative | 0 | 0 | 0 | |
| Total | 20 | 1 | 21 |
Sm Sensitivity (20/20)= 100%
Table 6 Sensitivity of the MarDx ENA IgG Immunostripe Test System relative to the INOVA RNP EIA Test System
| Antigen: RNP | INOVA RNP EIA | |||
|---|---|---|---|---|
| Positive | Negative | Total | ||
| MarDx | Positive | 33 | 0 | 33 |
| Immunostripe | ||||
| Negative | 4 | 0 | 4 | |
| Total | 37 | 0 | 37 |
RNP Sensitivity (33/37) = 89%
3
Table 7 Sensitivity of the MarDx ENA IgG Immunostripe Test System relative to the INOVA Jo-1 ElA Test System
| Antigen: Jo-1 | INOVA Jo-1 EIA | |||
|---|---|---|---|---|
| Positive | Negative | Total | ||
| MarDx | ||||
| Immunostripe | Positive | 2 | 0 | 2 |
| Negative | 0 | 0 | 0 | |
| Total | 2 | 0 | 2 |
Jo-1 Sensitivity (2/2)= 100%
Table 8 Sensitivity of the MarDx ENA IgG Immunostripe Test System relative to the INOVA Scl-70 ElA Test System
| Antigen: Scl-70 | INOVA Scl-70 | |||
|---|---|---|---|---|
| Positive | Negative | Total | ||
| MarDx | ||||
| Immunostripe | Positive | 7 | 0 | 7 |
| Negative | 0 | 0 | 0 | |
| Total | 7 | 0 | 7 |
Scl-70 Sensitivity (7/7)= 100%
Table 9
INOVA SUMMARY
Sensitivity of the MarDx ENA IgG Immunostripe Test System relative to the Six Combined Results from the INOVA ENA EIA Test Systems
| Combined | INOVA ENA EIA | |||
|---|---|---|---|---|
| Positive | Negative | Total | ||
| MarDx | ||||
| Immunostripe | Positive | 113 | 0 | 113 |
| Negative | 7 | 0 | 7 | |
| Total | 120 | 0 | 120 |
Sensitivity (113/120) = 94%
.
. .
4
Table 10
| MarDx ENA EIA | ||||
|---|---|---|---|---|
| Positive | Negative | Total | ||
| MarDx | ||||
| Immunostripe | Positive | 67 | 0 | 67 |
| Negative | 2 | 0 | 2 | |
| Total | 69 | 0 | 69 |
Sensitivity of the MarDx ENA IgG Immunostripe Test System relative to the MarDx 6 in 1 ENA EIA Test System
Sensitivity (67/69) = 97%
Table 11 Summary Table For All Data
| MarDx | Reference
Manufacturer | Number of
Specimens | Reference | Sensitivity | Specificity |
|--------------|--------------------------------------|------------------------|-----------|-------------|-------------|
| Immunostripe | vs INOVA | 35/37 | SSA | 95% | NA |
| Immunostripe | vs INOVA | 16/17 | SSB | 94% | NA |
| Immunostripe | vs INOVA | 20/20 | Sm | 100% | NA |
| Immunostripe | vs INOVA | 33/37 | RNP | 89% | NA |
| Immunostripe | vs INOVA | 2/2 | Jo-1 | 100% | NA |
| Immunostripe | vs INOVA | 7/7 | Scl-70 | 100% | NA |
| Immunostripe | vs INOVA | 40/40 | Normals | NA | 100% |
| Immunostripe | vs MarDx | 67/69 | 6 in 1 | 97% | NA |
| Immunostripe | vs MarDx | 139/139 | Normals | NA | 100% |
| Immunostripe | Combined Sensitivity and Specificity | | | 95% | 100% |
판
5
Precision Study
The precision data is presented in Table 10 for 7 sera (Jo-1, 3 sera) assayed 8 times each on three The precision data is presented in Table 10 for 7 Sera (60 1) 6 Series (60 million)
different assays. The data indicates that the MarDx ENA Immunostripe has a high degree of precision both within and between assays.
| Sample | Assay 1 | Assay 2 | Assay 3 | |||
|---|---|---|---|---|---|---|
| Ratio | Percent | Ratio | Percent | Ratio | Percent | |
| 1 SSA | 7/7 | 100% | 7/7 | 100% | 7/7 | 100% |
| 2 SSB | 7/7 | 100% | 7/7 | 100% | 7/7 | 100% |
| 3 Sm | 7/7 | 100% | 7/7 | 100% | 7/7 | 100% |
| 4 RNP | 7/7 | 100% | 7/7 | 100% | 7/7 | 100% |
| 5 Jo-1 | 3/3 | 100% | 3/3 | 100% | 3/3 | 100% |
| 6 Scl-70 | 7/7 | 100% | 7/7 | 100% | 7/7 | 100% |
| 7 Normal | 7/7 | 100% | 7/7 | 100% | 7/7 | 100% |
| TOTALS | 45/45 | 100% | 45/45 | 100% | 45/45 | 100% |
Table 12
Precision = 100%
Cross-Reactivity Study
The cross-reactivity data is presented in Table 11 for 7 sera containing dsDNA antibodies. The data is The cross-reactivity data is procemed in russ and cross-react with dsDNA.
| Table | 13 |
|---|---|
| ------- | ---- |
| Sample | Result |
|---|---|
| 1 | Neg |
| 2 | Neg |
| 3 | Neg |
| 4 | Neg |
| 5 | Neg |
| 6 | Neg |
| 7 | Neg |