(104 days)
IFA
Not Found
No
The device description and performance studies describe a standard enzyme-linked immunosorbent assay (ELISA) which is a biochemical method, not an AI/ML-based technology. There are no mentions of AI, ML, or related concepts in the summary.
No
This device is an in vitro diagnostic (IVD) assay designed to detect antibodies for diagnostic purposes (aid to diagnosis of microscopic polyangiitis), not to treat, mitigate, or cure a disease.
Yes
The device is an "aid to the diagnosis of microscopic polyangiitis" and is explicitly labeled "FOR IN VITRO DIAGNOSTIC USE," indicating its diagnostic purpose.
No
The device description clearly outlines a laboratory-based enzyme-linked immunosorbent assay (ELISA) which involves physical reagents, microtiter wells, and photometric measurement, indicating it is a hardware-based in vitro diagnostic device, not software only.
Yes, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states: "FOR IN VITRO DIAGNOSTIC USE."
Furthermore, the description of the device and its intended use aligns with the definition of an IVD: it is an assay used to detect antibodies in a human serum specimen to aid in the diagnosis of a specific medical condition (microscopic polyangiitis). This involves testing biological samples outside of the body, which is the core characteristic of an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The MPO EIA test is an enzyme-linked immunosorbent assay (EIA) for the detection and semi-quantitation of antibodies to myeloperoxidase in human sera. The assay is to be used to detect antibodies in a single serum specimen. The results of the assay are to be used as an aid to the diagnosis of microscopic polyangiitis. FOR IN VITRO DIAGNOSTIC USE.
Product codes (comma separated list FDA assigned to the subject device)
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Device Description
The MPO EIA test is an enzyme linked immunosorbent assay to detect IgG, IgM, and IgA antibodies to myeloperoxidase. Purified MPO is 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 anti-human IgG. M. A is added to each well. If antibody is present it will bind to the antibody attached to the antigen on the 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
human sera
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)
- Sensitivity and Specificity - The MPO ELISA kit was evaluated relative to IFA for ANCA. Forty sera were from patients diagnosed with Wegener's granulomatosis. Forty sera were from patients diagnosed with microscopic polyangiitis. One hundred and fifty five sera were from normals with various ages, gender, and geographical areas. The data in Table 1 summarizes the data. Note: the sensitivity and specificity relative to IFA will not be as high if random IFA positive sera are selected due to other disease states causing ANCA patterns not associated with MPO.
Comparison of MPO ELISA and ELISA (alternate ELISA) - The same group of clinical sera were tested on an legally marketed ELISA device to determine the relative sensitivity and specificity to an alternate ELISA. The data in Table 2 summarizes the data.
Clinical Sensitivity and Specificity - The clinical sera and the potentially cross-reactive sera were grouped and the clinical sensitivity and specificity of the MPO ELISA assay was calculated The data in Table 3 summarizes the data. - Precision - The precision of the MPO kit was determined by testing nine different sera eleven times each on three different assays. The data is summarized in Table 4. With proper technique the user should obtain C.V.'s of less than 15%.
- Linearity - The MPO index values were determined for serial twofold dilutions of five positive sera. The index values were compared to log2 of dilution by standard linear regression. The data in table #5 indicates that the assay is semi-quantitative.
- Cross Reactive Data - Sera containing high level of antibodies to potentially cross reactive antigens were assayed on the MPO ELISA kit. The data in table 6 indicate that antibodies to alternate autoimmune antigens do not cross react with the MPO ELISA kit.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Relative Sensitivity = 19/20 = 95.0%
95% Confidence interval = 85.3% - 100%
Relative Specificity = 213/213 = 100%
95% Confidence interval = 98.6% - 100%
Relative Agreement= 232/233 = 99.6%
95% Confidence interval = 98.7% - 100%
Relative Sensitivity = 6/7 = 85.7% 95% Confidence interval = 59.3% - 100%
Relative Specificity = 204/215 = 94.9% 95% Confidence interval = 91.9% - 97.9%
Relative Agreement= 210/222 = 94.6% 95% Confidence interval = 91.6% - 97.6%
Clinical Sensitivity Microscopic polyangiitis = 18/40 = 45.0%
95% confidence interval = 29.3 - 60.7%
Clinical Specificity Wegener's granulomatosis = 38/40 = 95.0%
95% confidence interval = 88.1 - 100%
Clinical Specificity Other autoimmune sera = 21/21 = 100%
95% confidence interval = 85.9 - 100%
Clinical Specificity Normals = 152/153 = 99.4%
95% confidence interval = 98.0 - 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.
IFA
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
§ 866.5660 Multiple autoantibodies immunological test system.
(a)
Identification. A multiple autoantibodies immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the autoantibodies (antibodies produced against the body's own tissues) in serum and other body fluids. Measurement of multiple autoantibodies aids in the diagnosis of autoimmune disorders (disease produced when the body's own tissues are injured by autoantibodies).(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/0 description: The image shows a close-up of the text "AB 19" in a bold, sans-serif font. The letters and numbers are solid black against a white background. The text appears to be part of a larger document or label.
Summary of Safety and Effectiveness Information MPO EIA Test Kit
- I. Immuno Probe Inc. 1306 Bailes Lane, Suite F Frederick. Maryland 21701 Contact person William Boteler Telephone: 301-695-7920 Date of preparation: June 28, 1996
- II. Description of Device
The MPO EIA test is an enzyme-linked immunosorbent assay (EIA) for the detection and semi-quantitation of antibodies to myeloperoxidase in human sera. The assay is to be used to detect antibodies in a single serum specimen. The results of the assay are to be used as an aid to the diagnosis of microscopic polyangiitis. FOR IN VITRO DIAGNOSTIC USE.
The MPO EIA test is an enzyme linked immunosorbent assay to detect IgG, IgM, and IgA antibodies to myeloperoxidase. Purified MPO is 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 anti-human IgG. M. A is added to each well. If antibody is present it will bind to the antibody attached to the antigen on the 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.
III. Predicate Device
The MPO EIA test is substantially equivalent to IFA. Equivalence is demonstrated by the following comparative results
1
Performance Characteristics
- Sensitivity and Specificity - The MPO ELISA kit was evaluated relative to IFA for ANCA. Forty sera were from patients diagnosed with Wegener's granulomatosis. Forty sera were from patients diagnosed with microscopic polyangiitis. One hundred and fifty five sera were from normals with various ages, gender, and geographical areas. The data in Table 1 summarizes the data. Note: the sensitivity and specificity relative to IFA will not be as high if random IFA positive sera are selected due to other disease states causing ANCA patterns not associated with MPO.
Table 1 Sensitivity and Specificity of the MPO ELISA Kit Relative to IFA
| | Positive
Index ≥ 1.10 | Equivocal
0.91-1.09 | Negative
≤ 90 | Total | |
|-----|--------------------------|------------------------|------------------|--------|-----|
| IFA | Positive | 19* | 0 | 1** | 20 |
| | Negative | 0 | 0 | 213*** | 213 |
| | Total | 19 | 0 | 214 | 233 |
MPO ELISA
| Relative Sensitivity = 19/20 = 95.0% | 95% Confidence interval = 85.3% - 100% |
|---|---|
| Relative Specificity = 213/213 = 100% | 95% Confidence interval = 98.6% - 100% |
| Relative Agreement= 232/233 = 99.6% | 95% Confidence interval = 98.7% - 100% |
The 95% confidence intervals were calculated using the normal method. The 95% confidence interval for Specificity was calculated assuming one false positive
- Thirteen sera were patients diagnosed with microscopic polyangitis with a p-ANCA pattern. One sera was from a patient diagnosed with Wegeners granulomatosis with a p-ANCA pattern. One sera was from a patient diagnosed with Wegeners granulomatosis with a c-ANCA pattern. Four sera were patients diagnosed with microscopic polyangiitis, that were positive for ANA thus making the p-ANCA pattern impossible to read.
** One serum was from a patient diagnosed with microscopic polyangiitis with a p-ANCA pattern.
*** Sixty serum were from patients diagnosed with microscopic polyangiitis or Wegeners granulomatosis that had c-ANCA patterns or negative for ANCA. One hundred fifty three serum were from normals negative for ANCA.
2
The same group of clinical sera were tested on an legally marketed ELISA device to determine the relative sensitivity and specificity to an alternate ELISA. The data in Table 2 summarizes the data.
Table 2 Comparison of MPO ELISA and ELISA
MPO ELISA
| | | Positive
Index ≥ 1.10 | Equivocal
0.91-1.09 | Negative
≤ 90 | Total |
|--------------------|-----------|--------------------------|------------------------|------------------|-------|
| | Positive | 6 | 0 | 1** | 7 |
| Alternate
ELISA | Equivocal | 4 | 0 | 7 | 11 |
| | Negative | 11* | 0 | 204 | 215 |
| | Total | 21 | 0 | 212 | 233 |
Relative Sensitivity = 6/7 = 85.7% 95% Confidence interval = 59.3% - 100% 95% Confidence interval = 91.9% - 97.9% Relative Specificity = 204/215 = 94.9% Relative Agreement= 210/222 = 94.6% 95% Confidence interval = 91.6% - 97.6%
The 95% confidence intervals were calculated using the normal method.
- Eight serum were from patients diagnosed with Microscopic polyangiitis. Two serum were from patients diagnosed with Wegeners Granulomatosis One serum was a normal.
** The serum was a normal.
3
The clinical sera and the potentially cross-reactive sera were grouped and the clinical sensitivity and specificity of the MPO ELISA assay was calculated The data in Table 3 summarizes the data.
Clinical Sensitivity and Specificity of MPO ELISA Table 3
MPO ELISA
| | Positive
Index ≥ 1.10 | Equivocal
0.91-1.09 | Negative
≤ 90 | Total |
|--------------------------|--------------------------|------------------------|------------------|-------|
| Microscopic polyangiitis | 18 | 0 | 22 | 40 |
| Wegener's granulomatosis | 2 | 0 | 38 | 40 |
| Other autoimmune sera | 0 | 0 | 21 | 21 |
| Normals | 1 | 0 | 152 | 153 |
| Total | 20 | 0 | 233 | 254 |
| Clinical Sensitivity Microscopic polyangiitis | = 18/40 | = 45.0% |
|---|---|---|
| 95% confidence interval | = 29.3 - 60.7% | |
| Clinical Specificity Wegener's granulomatosis | = 38/40 | = 95.0% |
| 95% confidence interval | = 88.1 - 100% | |
| Clinical Specificity Other autoimmune sera | = 21/21 | = 100% |
| 95% confidence interval | = 85.9 - 100% | |
| Clinical Specificity Normals | = 152/153 | = 99.4% |
| 95% confidence interval | = 98.0 - 100% |
The 95% confidence intervals were calculated using the normal method. The 95% confidence intervals for the clinical specificity for other autoimmune sera were calculated assuming one false positive.
4
2. Precision
The precision of the MPO kit was determined by testing nine different sera eleven times each on three different assays. The data is summarized in Table 4. With proper technique the user should obtain C.V.'s of less than 15%.
Table 4
| Assay 1 (n=11) | Assay 2 (n=11) | Assay 3 (n=11) | Inter Assay(n=33) | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| X | S.D. | C.V | X | S.D. | C.V. | X | S.D. | C.V. | X | SD | CV | |
| 1 | 4.60 | 0.137 | 2.99% | 4.39 | 0.222 | 5.06% | 4.53 | 0.347 | 7.67% | 4.5 | 0.258 | 5.73% |
| 2 | 5.13 | 0.136 | 2.66% | 4.97 | 0.236 | 4.74% | 5.12 | 0.432 | 8.44% | 5.08 | 0.295 | 5.81% |
| 3 | 3.53 | 0.227 | 6.43% | 3.21 | 0.217 | 6.75% | 3.32 | 0.192 | 5.79% | 3.36 | 0.248 | 7.38% |
| 4 | 2.76 | 0.218 | 7.90% | 2.51 | 0.338 | 13.45% | 2.74 | 0.282 | 10.29% | 2.67 | 0.297 | 11.13% |
| 5 | 0.41 | 0.079 | 19.19% | 0.37 | 0.067 | 17.92% | 0.44 | 0.070 | 15.93% | 0.41 | 0.076 | 18.58% |
| 6 | 0.04 | 0.021 | 46.53% | 0.05 | 0.017 | 35.78% | 0.04 | 0.024 | 59.49% | 0.04 | 0.020 | 46.08% |
| 7 | 0.05 | 0.17 | 36.14% | 0.05 | 0.018 | 38.94% | 0.05 | 0.028 | 60.79% | 0.05 | 0.021 | 45.24% |
| 8 | 0.92 | 0.049 | 5.32% | 0.84 | 0.054 | 6.42% | 0.88 | 0.060 | 6.85% | 0.88 | 0.063 | 7.14% |
| 9 | 1.08 | 0.064 | 5.95% | 0.94 | 0.055 | 5.91% | 0.97 | 0.04 | 4.10% | 0.97 | 0.094 | 9.67% |
- X = = Mean MPO Value S.D. = Standard Deviation C.V. = Coefficient of Variation
3. Linearity
The MPO index values were determined for serial twofold dilutions of five positive sera. The index values were compared to log2 of dilution by standard linear regression. The data in table #5 indicates that the assay is semi-quantitative.
| | Table 5
Linearity | | | | | | | | | |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------|------|------|------|------|------|------|-------|--|--|
| Serum | Neat | l :2 | 1:4 | 1.8 | 1 16 | 1:32 | 1:64 | | | |
| ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | 3.03 | 2.43 | 1.77 | 1.12 | 0 રો | | | 0 999 | | |
| ୍ୟ | 3.57 | 2.67 | 1.83 | 1 05 | 0 52 | | | 0.997 | | |
| 3 | 2.93 | 2.21 | 1.57 | 0 99 | 0 65 | | | 0 994 | | |
| 4 | 3.72 | 3.07 | 2.51 | 1.74 | 1 06 | 0.61 | | 0 998 | | |
| റ | 4.32 | 3.97 | 3.52 | 2.82 | 2 06 | 1.31 | 0.77 | 0.992 | | |
Linear regression compared MPO ISR to log2 of dilution.
5
4. Cross Reactive Data
Sera containing high level of antibodies to potentially cross reactive antigens were assayed on the MPO ELISA kit. The data in table 6 indicate that antibodies to alternate autoimmune antigens do not cross react with the MPO ELISA kit.
Table 6 Cross Reactive Data
| Serum # | Antibody Specificity | MPO Index Value | Interpretation |
|---|---|---|---|
| 1. | SM | 0 15 | - |
| 2. | SM | 0 36 | - |
| 3. | SM | 0 23 | - |
| 4. | RNP | 0 10 | - |
| 5. | RNP | 0 17 | - |
| 6. | RNP | 0 09 | - |
| 7. | Ro | 0 12 | - |
| 8. | Ro | 0 07 | - |
| 9. | Ro | 0 09 | - |
| 10. | La | 0 07 | - |
| 11. | La | 0 07 | - |
| 12. | La | 0 06 | - |
| 13. | Scl-70 | 0 10 | - |
| 14. | Scl-70 | 0 12 | - |
| 15. | Scl-70 | 0 08 | - |
| 16. | Jo- | 0 09 | - |
| 17. | Jo- | 0 10 | - |
| 18. | Jo-1 | 0 10 | - |
| 19. | dsDNA | 0 22 | - |
| 20. | dsDNA | 0 08 | - |
| 21 | dsDNA | 0 27 | - |