(65 days)
Wielisa PR-3 ANCA ELISA Kit, Wielisa MPO ANCA ELISA Kit, Wielisa anti-GBM ELISA Kit.
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No
The device description details a standard ELISA assay which relies on chemical reactions and optical density measurements, not AI/ML algorithms for interpretation. There is no mention of AI, ML, or related concepts in the document.
No
The device is an in vitro diagnostic (IVD) test used to aid in the diagnosis of specific conditions by detecting antibodies, not to treat or directly manage a disease.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states that the results of the assay "are to be used as an aid to the diagnosis of reno-pulmonary syndromes and rapidly progressive glomerulonephritis."
No
The device is described as an enzyme-linked immunosorbent assay (ELISA) test kit, which is a laboratory-based diagnostic test involving physical reagents and procedures, not solely software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states that the kit is an "enzyme-linked immunosorbent assay (ELISA) for the qualitative detection of antibodies... in human sera." It also states that the results are to be used "as an aid to the diagnosis" of specific medical conditions. This clearly indicates that the device is intended for use in vitro (outside the body) to examine specimens (human sera) to provide information for diagnostic purposes.
- Device Description: The "Device Description" further details the process of using the kit to detect antibodies in human serum specimens, reinforcing its in vitro nature.
- Performance Studies: The inclusion of "Clinical sensitivity and specificity" and "Relative sensitivity and specificity" studies, along with metrics like sensitivity and specificity, are typical for IVD devices demonstrating their performance in a clinical context.
The definition of an IVD generally includes devices intended for use in vitro for the examination of specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device fits that description perfectly.
N/A
Intended Use / Indications for Use
The Wielisa Anti-GBM, ANCA Screening Test Kit is an enzymelinked immunosorbent assay (ELISA) for the qualitative detection of antibodies to glomerular basement membrane (GBM), Proteinase-3 (PR-3) and 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 reno-pulmonary syndromes and rapidly progressive glomerulonephritis, especially Goodpasture syndrome (GP), Wegener's granulomatosis (WG) and microcopic polyangiitis (MP). The assay is intended for use in patients with signs and symptoms consistent with GP, WG, and MP. It is not intended for screening a healthy population. A positive result should always be confirmed by a semi-quantitative assay.
Product codes (comma separated list FDA assigned to the subject device)
DBL, MOB
Device Description
The Wielisa Anti-GBM, ANCA Screening Test Kit is an enzyme-linked immunosorbent assay (ELISA) for the qualitative detection of antibodies to glomerular basement membrane (GBM), Proteinase-3 (PR-3) and 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 reno-pulmonary syndromes and rapidly progressive glomerulonephritis, especially Goodpasture syndrome (GP). Wegener's granulomatosis (WG) and microcopic polyangiitis (MP). The assay is intended for use in patients with signs and symptoms consistent with GP, WG, and MP. It is not intended for screening a healthy population. A positive result should always be confirmed by a semi-quantitative assay.
The wells of the microtiter strips are coated with purified proteinase 3 (Human Neutrophil source). MPO (Human Neutrophil source) and GBM (Bovine source) antigen. 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 (Goat) 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 and the results are given as a ratio to the negative control.
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
A total of 326 frozen retrospective sera with clinical characterisation were assayed.
A total of 216 frozen retrospective sera were assayed on the Wielisa anti-GBM, ANCA screen kit and a semi-quantitative ELISA for PR-3 and MPO.
A total of 169 frozen retrospective sera were assayed on the Wielisa anti-GBM, ANCA screen kit and an semiquantitative ELISA for anti-GBM.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Clinical sensitivity and specificity study:
Sample size: 326 frozen retrospective sera.
Results Summary (Equivocal samples not included):
Clinical sensitivity for PR3-ANCA: WG = 39/42 = 92.9% (95% CI = 84.9 – 100%), MP = 21/41 = 51.2% (95% CI = 35.6-66.8%).
Clinical sensitivity for MPO-ANCA: WG = 4/41 = 9.8% (95% CI = 4.9 – 19.0%), MP = 20/43 = 46.5% (95% CI = 31.3-61.7%).
Clinical sensitivity for Anti-GBM: GP = 38/38 = 100% (95% CI = 92.2 – 100%).
Clinical specificity for PR3-ANCA: SLE = 31/31 = 100% (95% CI = 90.4 – 100%), RA = 41/41 = 100% (95% CI = 92.7 - 100%), NS = 131/131 = 100% (95% CI = 97.7 - 100%).
Clinical specificity for MPO-ANCA: SLE = 24/29 = 82.8% (95% CI = 68.7 - 96.8%), RA = 40/40 = 100% (95% CI = 92.6 - 100%), NS = 127/127 = 100% (95% CI = 97.6 - 100%).
Clinical specificity for Anti-GBM: SLE = 31/31 = 100% (95% CI = 90.4 -100%), RA = 41/41 = 100% (95% CI = 92.7 - 100%), NS = 128/128 = 100% (95% CI = 97.6 – 100%).
Relative sensitivity and specificity study compared to an alternative semi-quantitative ELISA:
Sample size: 216 frozen retrospective sera for PR-3 and MPO; 169 frozen retrospective sera for anti-GBM.
Results Summary (Equivocal samples not included):
Relative sensitivity for PR3-ANCA = 59/60 = 98.3% (95% CI = 95.0 - 100%).
Relative sensitivity for MPO-ANCA = 23/24 = 95.8% (95% CI = 87.7 - 100%).
Relative sensitivity for anti-GBM = 37/37 = 100% (95% CI = 92.0 - 100%).
Relative specificity for PR3-ANCA = 152/152 = 100% (95% CI = 98.0 - 100%).
Relative specificity for MPO-ANCA = 182/182 = 100% (95% CI = 98.4 - 100%).
Relative specificity for anti-GBM = 128/128 = 100% (95% CI = 97,7 - 100%).
Batch to batch variation study:
Results obtained for 4 different batches testing three different samples. Specific values are not easily extractable due to formatting but demonstrate variability.
Inter-assay precision study:
Results obtained for six different runs testing one sample.
Sample PK (PR3): Mean OD ratio = 27.3, SD = 2.9, CV % = 11.
Sample K5 (PR3): Mean OD ratio = 12.1, SD = 1.2, CV % = 10.
Sample PK (MPO): Mean OD ratio = 17.3, SD = 3.8, CV % = 21.
Sample K6 (MPO): Mean OD ratio = 16.5, SD = 0.84, CV % = 5.
Sample PK (GBM): Mean OD ratio = 16.5, SD = 1.1, CV % = 6.
Sample K4 (GBM): Mean OD ratio = 3.6, SD = 0.25, CV % = 7.
Intra-assay precision study:
Results obtained by testing one sample in 22 wells.
Sample PK (PR3): Mean OD = 1.3, SD = 0.07, CV % = 6.
Sample K5 (PR3): Mean OD = 1.3, SD = 0.06, CV % = 5.
Sample PK (MPO): Mean OD = 1.8, SD = 0.06, CV % = 3.
Sample K6 (MPO): Mean OD = 1.46, SD = 0.07, CV % = 5.
Sample PK (GBM): Mean OD = 1.2, SD = 0.19, CV % = 16.
Sample K4 (GBM): Mean OD = 0.6, SD = 0.03, CV % = 6.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Clinical sensitivity for PR3-ANCA: WG = 92.9 %, MP = 51.2 %.
Clinical sensitivity for MPO-ANCA: WG = 9.8 %, MP = 46.5 %.
Clinical sensitivity for Anti-GBM: GP = 100 %.
Clinical specificity for PR3-ANCA: SLE = 100 %, RA = 100 %, NS = 100 %.
Clinical specificity for MPO-ANCA: SLE = 82.8 %, RA = 100 %, NS = 100 %.
Clinical specificity for Anti-GBM: SLE = 100 %, RA = 100 %, NS = 100 %.
Relative sensitivity for PR3-ANCA = 98.3%.
Relative sensitivity for MPO-ANCA = 95.8%.
Relative sensitivity for anti-GBM = 100 %.
Relative specificity for PR3-ANCA = 100 %.
Relative specificity for MPO-ANCA= 100 %.
Relative specificity for anti-GBM = 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.
Wielisa PR-3 ANCA ELISA Kit, Wielisa MPO ANCA ELISA Kit, Wielisa anti-GBM ELISA Kit. (K numbers not provided in the text for predicate devices)
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).
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L
Summary of Safety and Effectiveness Information GBM, ANCA Screening ELISA Test Kit
Wieslab AB Ideon Research Park S-223 70 Lund Sweden Contact person: Dr. Jorgen Wieslander Telephone: 46-46-182840 Date of preparation: May 1, 1998
Description of Device: The Wielisa Anti-GBM, ANCA Screening Test Kit is an II. enzyme-linked immunosorbent assay (ELISA) for the qualitative detection of antibodies to glomerular basement membrane (GBM), Proteinase-3 (PR-3) and 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 reno-pulmonary syndromes and rapidly progressive glomerulonephritis, especially Goodpasture syndrome (GP). Wegener's granulomatosis (WG) and microcopic polyangiitis (MP). The assay is intended for use in patients with signs and symptoms consistent with GP, WG, and MP. It is not intended for screening a healthy population. A positive result should always be confirmed by a semi-quantitative assay.
The wells of the microtiter strips are coated with purified proteinase 3 (Human Neutrophil source). MPO (Human Neutrophil source) and GBM (Bovine source) antigen. 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 coniugate of alkaline phosphatase-labeled (Goat) 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 and the results are given as a ratio to the negative control.
III. Predicate Device
The GBM, ANCA Screening test is substantially equivalent to the Wielisa PR-3 ANCA ELISA Kit , the Wielisa MPO ANCA ELISA Kit and the Wielisa anti-GBM ELISA Kit. Equivalence is demonstrated by the following comparative results:
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| Control and
Disease groups | Total | Negative 4 | | |
|-------------------------------|-------|-------------|-----|-----|---------------|-----|-----|-------------|-----|-----|
| | | GBM | PR3 | MPO | GBM | PR3 | MPO | GBM | PR3 | MPO |
| Blood donors: (NS) | 131 | 128 | 131 | 127 | 3 | 0 | 4 | 0 | 0 | 0 |
| WG: | 42 | - | 3 | 37 | - | 0 | 1 | - | 39 | 4 |
| MP: | 43 | - | 20 | 23 | - | 2 | 0 | - | 21 | 20 |
| SLE: | 31 | 31 | 31 | 24 | 0 | 0 | 2 | 0 | 0 | 5* |
| RA: | 41 | 41 | 41 | 40 | 0 | 0 | 1 | 0 | 0 | 0 |
| GP: | 38 | 0 | - | - | 0 | - | - | 38 | - | - |
Table 1. Clinical sensitivity and specificity. A total of 326 frozen retrospective sera with clinical characterisation were assayed. The following table summarises the results
MP = microscopic polyangiitis RA = rheumatoid arthritis WG = Wegener's granulomatosis,
SLE = systemic lupus erythematosus GP = Goodpasture syndrome
- All samples were positive in semi-quantitative MPO-ELISA.
Clinical sensitivity (Equivocal samples are not included in the calculation)
| PR3-ANCA: | WG = 39/42 = 92.9 % | 95% CI = 84.9 – 100% |
|---|---|---|
| MP = 21/41 = 51.2 % | 95% CI = 35.6-66.8% | |
| MPO-ANCA: | WG = 4/41 = 9.8 % | 95% CI = 4.9 – 19.0% |
| MP = 20/43 = 46.5 % | 95% CI = 31.3-61.7% | |
| Anti-GBM: | GP = 38/38 = 100 % | 95% CI = 92.2 – 100% |
Clinical specificity (Equivocal samples are not included in the calculation)
| PR3-ANCA: | SLE = 31/31 = 100 %
RA = 41/41 = 100 %
NS = 131/131 = 100 % | 95% CI = 90.4 – 100%
95% CI = 92.7 - 100%
95% CI = 97.7 - 100% |
|-----------|--------------------------------------------------------------------|-----------------------------------------------------------------------|
| MPO-ANCA: | SLE = 24/29 = 82.8 %
RA = 40/40 = 100 %
NS = 127/127 = 100 % | 95% CI = 68.7 - 96.8%
95% CI = 92.6 - 100%
95% CI = 97.6 - 100% |
| Anti-GBM: | SLE = 31/31 = 100 %
RA = 41/41 = 100 %
NS = 128/128 = 100 % | 95% CI = 90.4 -100%
95% CI = 92.7 - 100%
95% CI = 97.6 – 100% |
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Table 2. Relative sensitivity and specificity of the Wielisa anti-GBM, ANCA screen kit compared to an alternative semi-quantitative ELISA. A total of 216 frozen retrospective sera were assayed on the Wielisa anti-GBM, ANCA screen kit and a semi-quantitative ELISA for PR-3 and MPO. Also, a total of 169 frozen retrospective sera were assayed on the Wielisa anti-GBM, ANCA screen kit and an semiquantitative ELISA for anti-GBM. The following table summarises the results.
| Semi-quantitative
ELISA | Negative 4 | | | |
|----------------------------|-------------|-----|-----|-----------|-----|-----|-------------|-----|-----|----|
| | GBM | PR3 | MPO | GBM | PR3 | MPO | GBM | PR3 | MPO | |
| MPO-ANCA | Positive | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 23 |
| PR3-ANCA | Positive | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 59 | 0 |
| Anti-GBM | Positive | 0 | - | - | 0 | - | - | 37 | - | - |
| | Negative | 128 | 152 | 182 | 3 | 2 | 4 | 0 | 0 | 0 |
| | Equivocal | 0 | 1 | 4 | 0 | 0 | 1 | 1 | 1 | 1 |
| | Total | 128 | 154 | 187 | 3 | 2 | 5 | 38 | 60 | 24 |
Relative sensitivity (Equivocal samples are not included in the calculation)
Relative sensitivity PR3-ANCA = 59/60 = 98.3% 95% CI = 95.0 - 100% Relative sensitivity MPO-ANCA = 23/24 = 95.8% 95% CI = 87.7 - 100% Relative sensitivity anti-GBM = 37/37 = 100 % 95% CI = 92.0 - 100%
Relative specificity (Equivocal samples are not included in the calculation)
Relative specificity PR3-ANCA = 152/152 = 100 % 95% CI = 98.0 - 100% Relative specificity MPO-ANCA= 182/182 = 100 % 95% CI = 98.4 - 100% Relative specificity anti-GBM = 128/128 = 100 % 95% CI = 97,7 - 100%
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Table 3. Batch to batch variation was determined by testing three different samples. Results were obtained for 4 different batches.
| PR3 | OD ratio | | Sample Mean SD CV% Sample Mean SD CV% Sample Mean SD CV%
MPO | OD ratio | | GBM | OD ratio | all and the controlled on the consideration of the comments of the comments of the comments of the comments of the many of the many of the many of the many of the many of the |
|-----|----------|--|--------------------------------------------------------------------------|----------|--|--------------------------------------------------|----------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 2 | | | 37.5 × 3.8 × 10 × 10 × 3 × 3 × 16.8 × × 2.2 × 13 × 13 × × 1 × 1 × × | | | | 21.8 | |
| | | | 24.3 23.6 3.6 15 15 15 6 1 | | | 31.5 1.5 1.9 1.9 6 6 2 4 4 29.0 29.0 2.2 2.2 4 4 | | |
| 8 | | | 35.5 % 2.4 % 777 % % 9 % 28.3 % % 1.5 % % 5 % % 7 % % 33.8 % % 2.4 % 7 % | | | | | |
Table 4. Inter-assay precision was determined by testing one sample. Results were obtained for six different runs.
| Sample | Mean
OD ratio | SD | CV % | Sample
MPO | Mean
OD ratio | SD | CV % | Sample
GBM | Mean
OD ratio | SD | CV % |
|--------|------------------|-----|------|---------------|------------------|------|------|---------------|------------------|------|------|
| PK | 27.3 | 2.9 | 11 | PK | 17.3 | 3.8 | 21 | PK | 16.5 | 1.1 | 6 |
| K5 | 12.1 | 1.2 | 10 | K6 | 16.5 | 0.84 | 5 | K4 | 3.6 | 0.25 | 7 |
Table 5. Intra-assay precision was determined by testing one sample in 22 wells.
| Sample
PR3 | Mean
OD | SD | CV % | Sample
MPO | Mean
OD | SD | CV % | Sample
GBM | Mean
OD | SD | CV% |
|---------------|------------|------|------|---------------|------------|------|------|---------------|------------|------|-----|
| PK | 1.3 | 0.07 | 6 | PK | 1.8 | 0.06 | 3 | PK | 1.2 | 0.19 | 16 |
| K5 | 1.3 | 0.06 | 5 | K6 | 1.46 | 0.07 | 5 | K4 | 0.6 | 0.03 | 6 |
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Image /page/4/Picture/2 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized abstract symbol resembling an eagle or bird in flight. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the symbol. The text is in all capital letters and is evenly spaced around the circle.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
JUL 22 1998
Weislab AB c/o William L. Boteler, Jr. IMMUNO PROBE, INC. 1306 Bailes Lane, Suite F Frederick, MD 21701
Re: K981750 Trade Name: Wielisa Anti-GBM, ANCA Screening Test Kit Regulatory Class: II Product Code: DBL, MOB Dated: May 3, 1998 Received: May 18, 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 regulations 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 requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General requlation (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 Requlations.
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Under the Clinical Laboratory Improvement Amendments of 1988 (CDIA-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 Sutman
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 K98) 750
Device Name: Wielisa Anti-GBM, ANCA Screening Test Kit
Indications For Use: The Wielisa Anti-GBM, ANCA Screening Test Kit is an enzymelinked immunosorbent assay (ELISA) for the qualitative detection of antibodies to glomerular basement membrane (GBM), Proteinase-3 (PR-3) and 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 reno-pulmonary syndromes and rapidly progressive glomerulonephritis, especially Goodpasture syndrome (GP), Wegener's granulomatosis (WG) and microcopic polyangiitis (MP). The assay is intended for use in patients with signs and symptoms consistent with GP, WG, and MP. It is not intended for screening a healthy population. A positive result should always be confirmed by a semi-quantitative assay.
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)
(Division Sign-Off)
Division of Clinical Laboratory Devices K981,750
510(k) Number