(104 days)
IFA
IFA
No
The device description details a standard ELISA assay, which is a biochemical method for detecting antibodies. There is no mention of AI or ML in the device description, performance studies, or key metrics.
No.
The device is an in vitro diagnostic (IVD) test intended to aid in the diagnosis of Wegener's granulomatosis by detecting antibodies in a serum specimen; it does not treat or prevent a disease.
Yes
The "Intended Use / Indications for Use" section explicitly states, "The results of the assay are to be used as an aid to the diagnosis of Wegener's granulomatosis. FOR IN VITRO DIAGNOSTIC USE." This directly indicates its role as a diagnostic device.
No
The device description clearly outlines a physical ELISA test kit involving 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).
Here's why:
- Explicit Statement: The "Intended Use / Indications for Use" section explicitly states: "FOR IN VITRO DIAGNOSTIC USE."
- Intended Use: The assay is designed to detect antibodies in a single serum specimen to aid in the diagnosis of Wegener's granulomatosis. This involves testing a sample taken from the human body in vitro (outside the body) to provide diagnostic information.
- Device Description: The description details a laboratory test (ELISA) performed on human serum, which is a biological specimen. The process involves chemical reactions and measurements performed on the sample.
All these points align with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The PR-3 ELISA test is an enzyme-linked immunosorbent assay (ELISA) for the detection and semi-quantitation of antibodies to Proteinase-3 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 Wegener's granulomatosis. FOR IN VITRO DIAGNOSTIC USE.
Product codes
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Device Description
The PR-3 ELISA test is an enzyme linked immunosorbent assay to detect IgG, IgM, and IgA antibodies to Proteinase-3. Purified PR-3 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
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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
-
Sensitivity and Specificity - The PR-3 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 polyangitis. One hundred and fifty five sera were from normals with various ages, gender, and geographical areas. The data in Table I 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 PR-3.
Study Type: Clinical Performance, Laboratory performance
Sample Size: 235 sera (54 IFA Positive, 181 IFA Negative); 256 sera (40 Wegener's granulomatosis, 40 Microscopic polyangiitis, 21 Other autoimmune sera, 155 Normals)
Key Results:
Relative Sensitivity = 53/54 = 98.2% (95% confidence interval = 94.5 - 100%)
Relative Specificity = 173/181 = 95.6% (95% confidence interval = 92.5 - 98.6%)
Relative Agreement = 226/235 = 96.2% (95% confidence interval = 93.7 - 98.7%)
Clinical Sensitivity Wegener's granulomatosis = 39/40 = 97.5% (95% confidence interval = 92.6 - 100%)
Clinical Sensitivity Microscopic polyangiitis = 22/40 = 55.0% (95% confidence interval = 39.3 - 70.7%)
Clinical Specificity Other autoimmune sera = 21/21 = 100% (95% confidence interval = 85.9 - 100%)
Clinical Specificity Normals = 155/155 = 100% (95% confidence interval = 98.1-100%) -
Precision - The precision of the PR-3 kit was determined by testing nine different sera ten times each on three different assays.
Study Type: Laboratory performance
Sample Size: 9 sera, 10 replicates each on 3 assays (total 30 replicates per serum)
Key Results: With proper technique the user should obtain C.V.'s of less than 15%.
CV values ranged from 1.95% to 80.36% (intra-assay) and 6.52% to 65.51% (inter-assay). -
Linearity - The ISR values were determined for serial twofold dilutions of five positive sera.
Study Type: Laboratory performance
Sample Size: 5 positive sera, serially diluted
Key Results: The assay has a linear relationship with serum dilution. Correlation coefficients (r) ranged from 0.984 to 0.995. -
Cross reactivity - Sera containing antibodies to potentially cross reactive antigens were assayed on the PR-3 ELISA.
Study Type: Laboratory performance
Sample Size: 21 sera with various antibody specificities (Ro, La, Sm, RNP, Jo-1, Scl-70, dsDNA)
Key Results: Sera containing antibodies to potentially of be reas autoimmune antigens do not cross react with the PR-3 ELISA kit. All tested sera yielded PR-3 Index Values well below the positive threshold.
Key Metrics
Relative Sensitivity = 98.2%
Relative Specificity = 95.6%
Relative Agreement = 96.2%
Clinical Sensitivity Wegener's granulomatosis = 97.5%
Clinical Sensitivity Microscopic polyangiitis = 55.0%
Clinical Specificity Other autoimmune sera = 100%
Clinical Specificity Normals = 100%
Precision: C.V.'s of less than 15% (goal, actual values provided in table)
Predicate Device(s)
IFA
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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
Summary of Safety and Effectiveness Information PR-3 ELISA 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
Description of Device II.
The PR-3 ELISA test is an enzyme-linked immunosorbent assay (ELISA) for the detection and semi-quantitation of antibodies to Proteinase-3 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 Wegener's granulomatosis. FOR IN VITRO DIAGNOSTIC USE.
The PR-3 ELISA test is an enzyme linked immunosorbent assay to detect IgG, IgM, and IgA antibodies to Proteinase-3. Purified PR-3 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 PR-3 ELISA test is substantially equivalent to IFA. Equivalence is demonstrated by the following comparative results:
1
Performance Characteristics
- Sensitivity and Specificity - The PR-3 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 polyangitis. One hundred and fifty five sera were from normals with various ages, gender, and geographical areas. The data in Table I 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 PR-3
Table 1 Sensitivity and Specificity of the PR-3 ELISA Kit Relative to IFA
| | | Positive
Index ≥ 1.10 | Equivocal
0.91-1.09 | Negative
≤ 90 | Total |
|-----|----------|--------------------------|------------------------|------------------|---------|
| IFA | Positive | 53* | 0 | 1*** | 54 |
| | | Negative | 8** | 0 | 173**** |
| | | Total | 61 | 0 | 174 |
Wampole PR-3 ELISA
| Relative Sensitivity = 53/54 = 98.2% | 95% confidence interval = 94.5 - 100% |
|---|---|
| Relative Specificity = 173/181 = 95.6% | 95% confidence interval = 92.5 - 98.6% |
| Relative Agreement = 226/235 = 96.2% | 95% confidence interval = 93.7 - 98.7% |
The 95% confidence intervals were calculated using the normal method.
*Fifty sera were from patients diagnosed with Wegeners granulomatosis or microscopic polyangiitis with a c-ANCA pattern. Two sera were from patients diagnosed with microscopic polyangitis with a p-ANCA pattern. One sera was from a patient diagnosed with microscopic polyangiitis with ANA thus making the c-ANCA pattern impossible to read.
** Eight sera were from patients diagnosed with Wegeners granulomatosis or microscopic polyangiitis that were negative for ANC A
***One serum was from a patient diagnosed with microscopic polyangiitis with a c-ANCA pattern.
*** One hundred and fifty five serum were from normals that were negative for ANCA. Eighteen sera were from patients diagnosed with microscopic polyangiitis with either a p-ANCA pattern or ANA or negative for ANCA.
2
The same group of clinical sera were tested on an legally marketed ELISA device to deemme the data The same group of cimcal sera were lested on an legally martered in Table 2 summarizes the data.
relative sensitivity and specificity to an alternate ELISA The data in Tab
Comparison of PR-3 ELISA and ELISA Table 2
PR-3 ELISA
| | | Positive
Index ≥ 1.10 | Equivocal
0.91-1.09 | Negative
≤ 90 | Total |
|--------------------|-----------|--------------------------|------------------------|------------------|-------|
| Alternate
ELISA | Positive | 58 | 0 | 5** | 63 |
| | Equivocal | 1 | 0 | 11 | 12 |
| | Negative | 2* | 0 | 158 | 160 |
| Total | | 61 | 0 | 174 | 235 |
| Relative Sensitivity = 58/63 = 92.1% | 95% confidence interval = 85.3 - 98.9% |
|---|---|
| Relative Specificity = 158/160 = 98.8% | 95% confidence interval = 97.0 - 1.00% |
| Relative Agreement = 216/223 = 98.9% | 95% confidence interval = 94.5 - 99.2% |
The 95% confidence intervals were calculated using the normal method.
- Both serum were from patients diagnosed with Microscopic Polyangiitis
** All five sera were from normals
3
The clinical sera and the potentially cross-reactive sera were grouped and the clinical sensitivity and specificity of the PR-3 ELISA assay was calculated. The data in Table 3 summarizes the data.
Clinical Sensitivity and Specificity of PR-3 ELISA Table 3
PR-3 ELISA
| | Positive
Index ≥ 1.10 | Equivocal
0.91-1.09 | Negative
≤ 90 | Total |
|--------------------------|--------------------------|------------------------|------------------|-------|
| Wegener's granulomatosis | 39 | 0 | 1 | 40 |
| Microscopic polyangiitis | 22 | 0 | 18 | 40 |
| Other autoimmune sera | 0 | 0 | 21 | 21 |
| Normals | 0 | 0 | 155 | 155 |
| Total | 61 | 0 | 195 | 256 |
| Clinical Sensitivity Wegener's granulomatosis | = 39/40 = 97.5% |
|---|---|
| 95% confidence interval | = 92.6 - 100% |
| Clinical Sensitivity Microscopic polyangiitis | = 22/40 = 55.0% |
| 95% confidence interval | = 39.3 - 70.7% |
| Clinical Specificity Other autoimmune sera | = 21/21 = 100% |
| 95% confidence interval | = 85.9 - 100% |
| Clinical Specificity Normals | = 155/155 = 100% |
| 95% confidence interval | = 98.1-100% |
The 95% confidence intervals were calculated using the normal method. The 95% confidence intervals for the clinical specificities were calculated assuming one false positive.
4
2. Precision
The precision of the PR-3 kit was determined by testing nine different sera ten 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%.
| E
| 1 | able | 1 | |
|---|---|---|---|
| Assay 1 (n=10) | Assay 2 (n=10) | Assay 3 (n=10) | Inter assay (n=30) | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Serum# | X | S.D. | C.V. | X | S.D. | C.V. | X | S.D. | C.V. | X | S.D. | C.V. |
| 1 | 8.70 | 0.634 | 7.29% | 8.92 | 0.479 | 5.37% | 9.37 | 0.465 | 4.96% | 9.00 | 0.586 | 6.52% |
| 2 | 2.99 | 0.345 | 11.54% | 3.03 | 0.211 | 6.96% | 2.92 | 0.201 | 6.89% | 2.98 | 0.256 | 8.59% |
| 3 | 2.68 | 0.289 | 10.81 | 2.76 | 0.145 | 5.25% | 2.70 | 0.144 | 5.32% | 2.71 | 0.200 | 7.38% |
| 4 | 2.52 | 0.177 | 7.04% | 2.52 | 0.163 | 6.47% | 2.53 | 0.242 | 9.54% | 2.52 | 0.190 | 7.54% |
| 5 | 10.33 | 0.344 | 3.34% | 11.95 | 0.293 | 2.45% | 10.29 | 0.200 | 1.95% | 10.86 | 0.837 | 7.71% |
| 6 | 0.17 | 0.074 | 42.79% | 0.15 | 0.056 | 37.79% | 0.010 | 0.076 | 80.36% | 0.14 | 0.074 | 53.76% |
| 7 | 0.08 | 0.037 | 47.16% | 0.06 | 0.039 | 68.22% | 0.04 | 0.037 | 84.50% | 0.06 | 0.039 | 65.51% |
| 8 | 1.28 | 0.079 | 6.13% | 1.31 | 0.071 | 5.37% | 1.21 | 0.079 | 6.53% | 1.27 | 0.086 | 6.74% |
| 9 | 1.08 | 0.059 | 5.45% | 1.18 | 0.105 | 8.92% | 1.06 | 0.083 | 7.91% | 1.10 | 0.097 | 8.82% |
3. Linearity
The ISR values were determined for serial twofold dilutions of five positive sera. The ISR values were compared to log2 of dilution by standard linear regression. The data in Table 5 indicates that the assay has a linear relationship with serum dilution.
| Table 5 | ||||||||
|---|---|---|---|---|---|---|---|---|
| Serum | Neat | 1:2 | 1:4 | 1:8 | 1:16 | 1:32 | 1:64 | r |
| 1 | 7.50 | 6.04 | 4.17 | 2.61 | 1.26 | 0.63 | 0.991 | |
| 2 | 2.96 | 2.09 | 1.47 | 0.97 | 0.37 | 0.995 | ||
| 3 | 8.44 | 6.98 | 5.22 | 3.66 | 2.36 | 1.37 | 0.60 | 0.992 |
| 4 | 2.24 | 1.88 | 1.23 | 0.63 | 0.993 | |||
| 5 | 3.24 | 1.94 | 0.98 | 0.43 | 0.984 |
5
4. Cross reactivity.
$335
Sera containing antibodies to potentially cross reactive antigens were assayed on the PR-3 ELISA. The Sera containing antibodies to potentially of be reas autoimmune antigens do not cross react with the PR-3 ELISA kit.
| Serum # | Antibody Specificity | PR-3 Index Value | Interpretation |
|---|---|---|---|
| 1. | Ro | 0.09 | - |
| 2. | Ro | 0.11 | - |
| 3. | Ro | 0.14 | - |
| 4. | La | 0.07 | - |
| 5. | La | 0.05 | - |
| 6. | La | 0.08 | - |
| 7. | Sm | 0.24 | - |
| 8. | Sm | 0.30 | - |
| 9. | Sm | 0.36 | - |
| 10. | RNP | 0.14 | - |
| 11. | RNP | 0.09 | - |
| 12. | RNP | 0.16 | - |
| 13. | Jo-1 | 0.05 | - |
| 14. | Jo-1 | 0.20 | - |
| 15. | Jo-1 | 0.12 | - |
| 16. | Scl-70 | 0.13 | - |
| 17. | Scl-70 | 0.07 | - |
| 18. | Scl-70 | 0.11 | - |
| 19. | dsDNA | 0.38 | - |
| 20. | dsDNA | 0.24 | - |
| 21. | dsDNA | 0.36 | - |