(104 days)
Immunoscan MPO ANCA ELISA Kit
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No
The description details a standard ELISA assay which relies on chemical reactions and optical density measurements, not AI/ML algorithms for analysis or interpretation. There are no mentions of AI, ML, or related concepts in the summary.
No
This device is an in vitro diagnostic test used to aid in the diagnosis of a condition by detecting antibodies; it does not provide therapy or treatment.
Yes.
The device's intended use is to "aid to the diagnosis of Microscopic polyangiitis," which signifies its role in supporting a medical diagnosis.
No
The device is an in vitro diagnostic (IVD) test kit that involves physical reagents, incubation steps, and measurement of optical density, indicating it is a hardware-based assay, not software-only.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The description explicitly states "FOR IN VITRO DIAGNOSTIC USE." It also describes the assay as being used to detect antibodies in human serum as an aid to the diagnosis of Microscopic polyangiitis. This clearly indicates the device is intended for use outside of the body to diagnose a disease.
- Device Description: The description details a laboratory test (ELISA) performed on a human sample (serum) to detect a specific analyte (IgG antibodies to MPO). This is a hallmark of an in vitro diagnostic device.
- Intended User / Care Setting: The mention of "FOR IN VITRO DIAGNOSTIC USE" again reinforces its intended use in a laboratory or clinical setting for diagnostic purposes.
The entire description aligns 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 a potential recipient with a potential donor, or to monitor therapeutic measures.
N/A
Intended Use / Indications for Use
The Wielisa MPO ANCA Test Kit is an enzyme-linked immunosorbent assay (ELISA) for the detection and semi-quantitation of IgG antibodies to myeloperoxidase (MPO) 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 microscopic polyangiitis. FOR IN VITRO DIAGNOSTIC USE.
Product codes
MOB 82
Device Description
The Wielisa MPO ANCA Test Kit is an enzyme-linked immunosorbent assay (ELISA) for the detection and semi-quantitation of IgG antibodies to myeloperoxidase (MPO) 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 microscopic polyangiitis. FOR IN VITRO DIAGNOSTIC USE.
The wells of the microtiter strips are coated with purified myeloperoxidase. 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.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Clinical Sensitivity and Specificity
Study Type: Clinical
Sample Size: 364 frozen retrospective sera with clinical characterization.
Key Results:
- Clinical Sensitivity (Equivocal samples excluded):
- WG = 9/66 = 13.6% (95% confidence interval = 5.2-22.1%)
- MP = 24/51 = 47.1% (95% confidence interval = 33.1-61.0%)
- GBM = 17/51 = 33.3% (95% confidence interval = 20.1-46.5%)
- Clinical Specificity (Equivocal samples excluded):
- SLE = 33/34 = 97.1% (95% confidence interval = 91.3-100%)
- RA = 17/17 = 100% (*95% confidence interval = 82.7-100%)
- Normals = 120/120 = 100% (*95% confidence interval = 97.5-100%)
Relative Sensitivity and Specificity of the Wielisa MPO ANCA Kit Compared to P-ANCA IFA
Study Type: Comparative study
Sample Size: 245 sera
Key Results:
- Relative Sensitivity = 22/26 = 84.6 % (95% Confidence Interval: 70.5 - 98.8 %)
- Relative Specificity = 200/211 = 94.8 % (95% Confidence Interval: 91.7 - 97.9 %)
- Relative Accuracy = 222/237 = 93.7 % (95% Confidence Interval: 90.5 - 96.8 %)
Relative Sensitivity and Specificity of the Wielisa MPO Kit Compared to an Alternate ELISA
Study Type: Comparative study
Sample Size: 129 frozen retrospective sera
Key Results:
- Relative Sensitivity = 42/44 = 96.0 % (95% Confidence Interval: 89.2 - 100 %)
- Relative Specificity = 84/85 = 98.8 % (95% Confidence Interval: 96.5 - 100 %)
- Relative Accuracy = 126/129 = 97.7 % (95% Confidence Interval: 95.0 - 100 %)
Batch to batch variation
Study Type: Precision study
Sample Size: 7 different samples, tested in duplicate for 4 to 6 different batches.
Key Results: CV% ranged from 5.5% to 26.0%.
Inter-assay precision
Study Type: Precision study
Sample Size: 2 different samples, tested in duplicate for 6 different runs.
Key Results: CV% were 13.5% and 19.8%.
Intra-assay precision
Study Type: Precision study
Sample Size: 1 sample in 80 wells.
Key Results: CV% was 15.6%.
Linearity
Study Type: Linearity study
Sample Size: Serial two-fold dilutions of six positive sera.
Key Results: The data indicates that the assay has a linear relationship with serum dilution. Correlation coefficient (r) ranged from 0.893 to 0.996.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
- Clinical Sensitivity: 13.6% (WG), 47.1% (MP), 33.3% (GBM)
- Clinical Specificity: 97.1% (SLE), 100% (RA), 100% (Normals)
- Relative Sensitivity (vs P-ANCA IFA): 84.6 %
- Relative Specificity (vs P-ANCA IFA): 94.8 %
- Relative Accuracy (vs P-ANCA IFA): 93.7 %
- Relative Sensitivity (vs Alternate ELISA): 96.0 %
- Relative Specificity (vs Alternate ELISA): 98.8 %
- Relative Accuracy (vs Alternate ELISA): 97.7 %
Predicate Device(s)
Immunoscan MPO ANCA ELISA Kit
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
Summary of Safety and Effectiveness Information MPO ANCA Test Kit
FEB 1 7 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
l.
Description of Device: The Wielisa MPO ANCA Test Kit is an enzyme-linked ll. immunosorbent assay (ELISA) for the detection and semi-quantitation of IgG antibodies to myeloperoxidase (MPO) 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 microscopic polyangiitis. FOR IN VITRO DIAGNOSTIC USE.
The wells of the microtiter strips are coated with purified myeloperoxidase. 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.
- Predicate Device
The MPO ANCA test is substantially equivalent to the Immunoscan MPO 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 results.
| Control and
Disease groups | Total
number | Negative
20 units |
|-------------------------------|-----------------|-----------------------|--------------------------|-----------------------|
| Healthy Normals: | 120 | 120 | 0 | 0 |
| WG: | 70 | 57 | 4 | 9 |
| MP: | 55 | 27 | 4 | 24 |
| SLE: | 40 | 33 | 6 | 1 |
| RA: | 17 | 17 | 0 | 0 |
| Anti-GBM nephritis: | 62 | 34 | 11 | 17 |
MP = microscopic polyangiitis GBM = glomerular basement membrane WG = Wegener's granulomatosis, SLE = systemic lupus erythematosus RA = rheumatoid arthritis
Clinical Sensitivity (Equivocal samples excluded from calculations)
| WG = 9/66 = 13.6% | 95% confidence interval = 5.2-22.1% |
|---|---|
| MP = 24/51 = 47.1% | 95% confidence interval = 33.1-61.0% |
| GBM = 17/51 = 33.3% | 95% confidence interval = 20.1-46.5% |
Clinical Specificity (Equivocal samples excluded from calculations)
| SLE | = 33/34 = 97.1% | 95% confidence interval = 91.3-100% |
|---|---|---|
| RA | = 17/17 = 100% | *95% confidence interval = 82.7-100% |
| 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.
ﻤ
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Table 2 A total of 245 sera were assayed on the Wielisa MPO ANCA Elisa and IFA. The following table summarizes the relative sensitivity and specificity.
Relative Sensitivity and Specificity of the Wielisa MPO ANCA Kit Compared to P-ANCA IFA .
| Wielisa MPO ANCA | |||||
|---|---|---|---|---|---|
| Positive | Equivocal | Negative | Total | ||
| P-ANCA | |||||
| IFA | Positive | 22 | 0 | 4 | 26 |
| P-ANCA | |||||
| IFA | Negative | 11 | 8 | 200 | 219 |
| Total | 33 | 8 | 204 | 245 |
Sera falling in the equivocal range were excluded from the following calculations
| 95% Confidence Interval | |||
|---|---|---|---|
| Relative Sensitivity | = 22/26 | = 84.6 % | 70.5 - 98.8 % |
| Relative Specificity | = 200/211 | = 94.8 % | 91.7 - 97.9 % |
| Relative Accuracy | = 222/237 | = 93.7 % | 90.5 - 96.8 % |
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Table 3 A total of 129 frozen retrospective sera were assayed by the Wielisa MPO 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 MPO Kit Compared to an Alternate ELISA
MPO Wielisa
| Positive | Equivocal | Negative | Total | ||
|---|---|---|---|---|---|
| Positive | 42 | 0 | 2* | 44 | |
| Alternate | |||||
| ELISA | Equivocal | 1 | 0 | 19 | 20 |
| Negative | 0 | 0 | 65 | 65 | |
| Total | 43 | 0 | 86 | 129 | |
| 95% Confidence Interval | |||||
| Relative Sensitivity | |||||
| Relative Specificity | |||||
| Relative Accuracy | = 42/44 = 96.0 % | ||||
| = 84/85 = 98.8 % | |||||
| = 126/129 = 97.7 % | 89.2 - 100 % | ||||
| 96.5 - 100 % | |||||
| 95.0 - 100 % |
Sera falling in the equivocal range were considered to be negative.
- Both samples were from normal healthy patients.
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Table 4. Batch to batch variation.
Batch to batch variation was determined by testing seven different samples in duplicate. Results were obtained for four to six different batches.
| Sample | Mean value | SD | CV % |
|---|---|---|---|
| 1 | 23 units | 6.0 | 26.0 |
| 2 | 73 units | 4.0 | 5.5 |
| 3 | 149 units | 28.2 | 18.9 |
| 4 | 20 units | 2.8 | 14 |
| 5 | 21 units | 2.5 | 12 |
| 6 | 20 units | 3.8 | 19 |
| 7 | 23 units | 1.4 | 6 |
Table 5. Inter-assay precision.
Inter-assay precision was determined by testing two different samples in duplicate. Results were obtained for six different runs. and the same of the same of the same of the same of the seat of the seat of the seat the seat the seat and
| Sample | Mean value | SD | CV % |
|---|---|---|---|
| 1 | 63 units | 8.5 | 13.5 |
| 2 | 169 units | 33.5 | 19.8 |
Table 6. Intra-assay precision.
| Intra-assay precision was determined by testing one sample in 80 wells. | ||||||
|---|---|---|---|---|---|---|
| Sample | Mean value | SD | CV % | |||
| 49 units | .O | 15.6 |
Table 7. Linearity
The values were determined for serial two-fold dilutions of six 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 | 163 | કર્ | 41 | 20 | 00 | 2 | 0.927 | |
| 2 | 74 | રર | 39 | 18 | 7 | 0.996 | ||
| 3 | 146 | 83 | રે રેણે રહ્યા છે. આ ગામનાં પ્રાથમિક શાળા, આંગણવાડી તેમ જ દૂધની ડેરી જેવી સવલતો પ્રાપ્ય થયેલી છે. આ ગામનાં પ્રાથમિક શાળા, પંચાયતઘર, આંગણવાડી તેમ જ દૂધની ડેરી જેવી સવલતો પ્રાપ | 26 | 12 | ব | 0.951 | |
| 4 | 258 | 162 | 112 | રેર | 34 | 19 | 8 | 0.943 |
| ર | 310 | 140 | 74 | 40 | 20 | d | 0.893 | |
| ર | 34 | 23 | 13 | 7 | 0.989 |
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Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the symbol. The caduceus is black, and the text is also black. The logo is simple and recognizable, and it is used to represent the U.S. Department of Health & Human Services.
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
FEB 17 1998
Re : K974166 Trade Name: Wielisa MPO ANCA Test Kit Regulatory Class: II Product Code: MOB 82 Dated: January 19, 1998 Received: January 20, 1998
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 requlations affecting your device can be found in the Code of Federal Regulations, 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 In addition, FDA may publish further regulatory action. 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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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 leqally 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 Autman
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
K974166 510(k) Number: Not known
Device Name: Wielisa MPO ANCA Test Kit
Indications For Use: Wielisa MPO ANCA Test Kit. An Enzyme Linked Immunosorbent Assay (ELISA) for the detection and semi-quantitation of IgG antibodies in human serum to MPO (Myeloperoxidase). 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 Microscopic polyangiitis.
Peter E. Maxon
(Division Sign Off)
Division of Clinical Laboratory De 510(k) Number
PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) xt 「やっしりロア」
Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use V OR Over-The Counter Use (Optional Format 1-2-96) (Per 21 CFR 801.109)