← Product Code [MOB](/submissions/IM/subpart-f%E2%80%94immunological-test-systems/MOB) · K974167
# WIELISA PR-3 ANCA TEST SYSTEM (K974167)
_Wieslab AB · MOB · Feb 17, 1998 · Immunology · SESE_
**Canonical URL:** https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/MOB/K974167
## Device Facts
- **Applicant:** Wieslab AB
- **Product Code:** [MOB](/submissions/IM/subpart-f%E2%80%94immunological-test-systems/MOB.md)
- **Decision Date:** Feb 17, 1998
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 866.5660
- **Device Class:** Class 2
- **Review Panel:** Immunology
## Intended Use
The Wielisa PR-3 ANCA Test Kit is an enzyme-linked immunosorbent assay (ELISA) for the detection and semi-quantitation of antibodies to Proteinase-3 (PR-3) in human sera. The assay is 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.
## Device Story
Wielisa PR-3 ANCA Test Kit is an ELISA for detecting IgG antibodies to Proteinase-3 in human serum. Microtiter wells are coated with purified PR-3 antigen. Patient serum is incubated; specific antibodies bind to the antigen. After washing, alkaline phosphatase-labeled anti-human IgG conjugate is added. Following a second wash, substrate solution is added; color intensity, measured as optical density (OD), correlates to antibody concentration. Results are calculated against a calibrator curve and expressed in arbitrary units. Used in clinical laboratories by trained personnel to aid in diagnosing Wegener's granulomatosis. Output provides semi-quantitative antibody levels, assisting clinicians in evaluating patients suspected of having this condition.
## Clinical Evidence
Bench testing and retrospective clinical evaluation. Study of 364 sera showed 92.9% sensitivity for Wegener's granulomatosis (WG) and 50.0% for microscopic polyangiitis (MP). Specificity: 100% for healthy normals and RA, 97.4% for SLE, 93.6% for anti-GBM nephritis. Comparison with C-ANCA IFA (n=245) showed 96.3% relative sensitivity and 91.9% relative specificity. Comparison with alternate ELISA (n=120) showed 100% relative sensitivity and 97.5% relative specificity. Precision and linearity data provided.
## Technological Characteristics
ELISA-based immunoassay. Components: microtiter strips coated with purified proteinase 3, alkaline phosphatase-labeled anti-human IgG conjugate, substrate solution. Detection via optical density measurement. Semi-quantitative output in arbitrary units. Manual or automated plate reader required.
## Regulatory 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).
## Predicate Devices
- Immunoscan PR-3 ANCA ELISA Kit
## Submission Summary (Full Text)
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K974167
### Summary of Safety and Effectiveness Information PR-3 ANCA Test Kit
# FEB 17 1998
Wieslab AB Ideon Research Park S-223 70 Lund Sweden Contact person: Dr. Jorgen Wieslander Telephone: 46-46-182840 Date of preparation: Jan 19, 1998
【.
Description of Device: The Wielisa PR-3 ANCA Test Kit is an enzyme-linked immunosorbent 11. assay (ELISA) for the detection and semi-quantitation of lgG antibodies to Proteinase-3 (PR-3) in human sera. The assay is 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 wells of the microtiter strips are coated with purified proteinase 3. During the first incubation, specific antibodies in diluted serum, will bind to the antigen coating,
The wells are then washed to remove unbound antibodies and other components. A conjugate of alkaline phosphatase-labeled antibodies to human IgG binds to the antibodies in the wells in this second incubation.
After a further washing step, detection of specific antibodies is obtained by incubation with substrate solution. The amount of bound antibodies correlates to the color intensity and is measured in terms of absorbance (optical density (OD)). The absorbance is then calculated against a calibrator curve and the results are given in arbitrary units.
#### 111. Predicate Device
The PR-3 ANCA test is substantially equivalent to the Immunoscan PR-3 ANCA ELISA Kit. Equivalence is demonstrated by the following comparative results:
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Table 1. Clinical Sensitivity and Specificity A total of 364 frozen retrospective sera with clinical characterization were assayed. The following table summarizes the data.
| Control and
Disease groups | Total
number | Negative
<10 units | Equivocal
10-20 units | Positive
>20 units |
|-------------------------------|-----------------|-----------------------|--------------------------|-----------------------|
| Healthy Normals: | 120 | 120 | 0 | 0 |
| WG: | 70 | 5 | 0 | 65 |
| MP: | 55 | 26 | 3 | 26 |
| SLE: | 40 | 38 | 1 | 1 |
| RA: | 17 | 17 | 0 | 0 |
| Anti-GBM nephritis: | 62 | 58 | 0 | 4 |
GBM = glomerular basement membrane
WG = Wegener's granulomatosis, SLE = systemic lupus erythematosus
MP = microscopic polyangiitis
RA = rheumatoid arthritis
Clinical Sensitivity (Equivocal samples excluded from calculations)
| WG = 65/70 = 92.9% | 95% confidence interval = 86.7-99.0% |
|--------------------|--------------------------------------|
| MP = 26/52 = 50.0% | 95% confidence interval = 36.1-63.9% |
### Clinical Specificity (Equivocal samples excluded from calculations)
| SLE | = 38/39 | = 97.4% | 95% confidence interval = 92.4-100% |
|---------|-----------|---------|--------------------------------------|
| RA | = 17/17 | = 100% | *95% confidence interval = 82.7-100% |
| GBM | = 58/62 | = 93.6% | 95% confidence interval = 87.3-99.8% |
| Normals | = 120/120 | = 100% | *95% confidence interval = 97.5-100% |
The 95% confidence intervals were calculated using the normal method. *The 95% confidence intervals were calculated assuming one false positive.
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Table 2 A total of 245 frozen retrospective sera were assayed on the Wielisa PR-3 ANCA ELISA and IFA. The following Table summarizes the relative sensitivity and specificity.
### Relative Sensitivity and Specificity of the Wielisa PR-3 ANCA Compared to C-ANCA IFA
| | | Positive | Equivocal | Negative | Total |
|---------------|----------|----------|-----------|----------|-------|
| C-ANCA
IFA | Positive | 78 | 0 | 3 | 81 |
| | Negative | 13 | 3 | 148 | 164 |
| | Total | 91 | 3 | 151 | 245 |
Sera falling in the equivocal range were excluded from the following calculations
| | | | 95% Confidence Interval |
|----------------------|-----------|----------|-------------------------|
| Relative Sensitivity | = 78/81 | = 96.3 % | 92.1 - 100.0 % |
| Relative Specificity | = 148/161 | = 91.9 % | 87.6 - 96.2 % |
| Relative Accuracy | = 226/242 | = 93.4 % | 90.2 - 96.6 % |
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Table 3 A total of 120 frozen retrospective sera were assayed by the Wielisa PR-3 ANCA ELISA and by an alternate commercial ELISA. The following table summarizes the relative sensitivity and specificity of the assay.
### Relative Sensitivity and Specificity of the Wielisa PR-3 Kit Compared to an Alternate ELISA .• -•
## PR-3 Wielisa
| | | Positive | Equivocal | Negative | Total |
|--------------------|-----------|----------|-----------|----------|-------|
| | Positive | 37 | 0 | 0 | 37 |
| Alternate
ELISA | Equivocal | 1 | 0 | 1 | 2 |
| | Negative | 2** | 0 | 79 | 81 |
| | Total | 40 | 0 | 80 | 120 |
Sera falling in the equivocal range were excluded from the following calculations
| | | 95% Confidence Interval |
|----------------------|--------------------|-------------------------|
| Relative Sensitivity | = 37/37 = 100 % | 92.0 - 100 %* |
| Relative Specificity | = 79/81 = 97.5 % | 94.1 - 100 % |
| Relative Accuracy | = 116/118 = 98.3 % | 95.9 - 100 % |
* One false negative was included in this caclulation.
** Both sera were from vasculitis patients
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### Table 4. Batch to batch variation.
Batch to batch variation was determined by testing 4 different samples in duplicate. Results were obtained for four different batches.
| Sample | Mean value | SD | CV % |
|--------|------------|-----|------|
| 1 | 25 units | 2.3 | 9.1 |
| 2 | 29 units | 4.1 | 14.3 |
| 3 | 68 units | 8.7 | 12.7 |
| 4 | 76 units | 6.7 | 8.9 |
### Table 5. Inter-assay precision.
Inter-assay precision was determined by testing 2 different samples in duplicate. Results were obtained for six different runs.
| the change on the collection in the contraction to the contraction and the collection of the color controlled in
AND A LINE BOOK OF CHARREN FOR AND ANDREA
Sample | I a sual manimal a minutes
Mean value | LE LEB LE LE RE MENSION AN FERRENCE CHARRIES CHARACT CHARACT CHARACT CHARACT CHARACT CHARACT CHARACT CHARACT CHARACT CHARACT CHARACT CHARACT CHARACT CHARACT CHARACT CHARACT C
C | AT R CLEAR SECTIONAL
STAR I IT AN ANNUAL CAR AN AN AN AN AN AN AN AN AN AN A CHANAL AND AND THE CHANALY
CV %
S | ------------ |
|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | 75 units | 1000 0 - | 1
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| | 22 units
t
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| 1
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### Table 6. Intra-assay precision.
Intra-assay precision was determined by testing one sample in 80 wells.
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#### Table 7. Linearity
.
The values were determined for serial two-fold dilutions of seven positive sera. The values were compared to log2 of dilution by standard linear regression. The data in Table 7 indicates that the assay has a linear relationship with serum dilution.
| Serum | Neat | 1:2 | 1:4 | 1:8 | 1:16 | 1:32 | 1:64 | r |
|-------|------|-----|-----|-----|------|------|------|-------|
| 1 | 168 | 95 | 57 | 34 | 15 | 5 | | 0.945 |
| 2 | 84 | 43 | 23 | 13 | 5 | | | 0.942 |
| 3 | 230 | 80 | 50 | 31 | 19 | 7 | | 0.851 |
| 4 | 200 | 130 | 81 | 38 | 19 | 10 | 6 | 0.935 |
| 5 | 269 | 146 | 64 | 34 | 20 | 9.5 | | 0.908 |
| 6 | 276 | 75 | 46 | 26 | 12 | 8 | | 0.811 |
| 7 | 141 | 73 | 50 | 30 | 16 | 8 | | 0.931 |
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Image /page/5/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with three profiles of human faces incorporated into its design. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
WEISLAB AB William L. Boteler c/o IMMUNO PROBE, INC. 1306 Bailes Lane, Suite F Frederick, MD 21701
FFB 17 1998
Re: K974167 Trade Name: Wielisa PR-3 ANCA Test System Regulatory Class: II Product Code: MOB 82 Dated: January 19, 1998 January 20, 1998 Received:
Dear Mr. Boteler:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Page 2
Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. TO determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at (770)488-7655.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll free number (800) 638-2041 or at (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html"
Sincerely yours,
Steven Putman
Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page 1 of 1
510(k) Number: Not known ¥974167
Device Name: Wielisa PR-3 ANCA Test Kit
Indications For Use: The Wielisa PR-3 ANCA Test Kit is an enzyme-linked immunosorbent assay (ELISA) for the detection and semi-quantitation of antibodies to Proteinase-3 (PR-3) in human sera. The assay is 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.
Peter E. Makin
(Division Sign-Off) (Division of Clinical Laboratory Devices LG 74 16
PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use V (Per 21 CFR 801.109)
OR
Over-The Counter Use (Optional Format 1-2-96)
---
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