(55 days)
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No
The document describes a standard enzyme immunoassay (EIA) kit for detecting antibodies. There is no mention of AI, ML, or any computational analysis beyond standard assay interpretation.
No
The device is an in vitro diagnostic (IVD) kit used for the semi-quantitative and qualitative determination of antibodies to aid in diagnosis, not to treat a disease or condition.
Yes
The device is designed to aid in the diagnosis of specific autoimmune vasculitides by semi-quantitatively and qualitatively determining myeloperoxidase anti-neutrophil cytoplasmic antibodies (MPO ANCA) in human samples.
No
The device is a laboratory test kit containing physical components such as microplate strips, calibrators, controls, and reagents, indicating it is a hardware-based medical device, not software-only.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's for the "semi-quantitative and qualitative determination of myeloperoxidase anti neutrophil cytoplasmatic antibodies (MPO ANCA) in human serum or plasma". This involves testing a sample taken from the human body (serum or plasma) in vitro (outside the body).
- Device Description: The description details an "indirect noncompetitive enzyme immunoassay" that uses "human serum or plasma" samples. It also lists components like "microplate strips," "calibrators," "controls," "enzyme-labeled conjugate," "substrate," and "wash buffer," which are typical components of an in vitro diagnostic test kit.
- Mechanism: The test works by detecting antibodies in the patient sample that bind to an antigen on the microplate. This is a common method used in in vitro diagnostic tests to identify specific substances in biological samples.
The information provided clearly indicates that this device is designed to perform a test on a biological sample outside of the body to provide information for medical diagnosis, which is the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Varelisa MPO ANCA EIA kit is designed for the semi-quantitative and The varensa mro of myeloperoxidase anti neutrophil cytoplasmatic antibodies (MPO ANCA) in human serum or plasma to aid in the diagnosis of antiooules (11) O Free vasculitides such as microscopic polyangiitis, and crescentic glomerulonephritis.
Product codes (comma separated list FDA assigned to the subject device)
MOB
Device Description
Varelisa MPO ANCA is an indirect noncompetitive enzyme immunoassay for the semiquantitative and qualitative determination of MPO ANCA in human serum or plasma. Antibodies specific for MPO present in the patient sample bind to the antigen.
The test kit contains microplate strips coated with human purified MPO ANCA antigen, calibrators, positive and negative controls, enzyme-labeled conjugate, substrate and substrate stop solution, Sample Diluent and wash buffer.
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)
The comparability of INOVA QUANTA Lite™ MPO and Pharmacia Varelisa MPO ANCA is supported by a data set including
- · results obtained within a comparison study analyzing positive, equivocal and negative sera.
- · results obtained for externally defined Calibrators and clinically defined sera.
- · results obtained for samples from apparently healthy subjects (normal population).
The data show that the assay performs as expected from the medical literature.
In summary, all available data support that the new device, PHARMACIA Varelisa MPO ANCA Assay is substantially equivalent to the predicate device, INOVA QUANTA Lite™ MPO Assay, and that the new device performs according to state-of-the-art expectations.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
INOVA QUANTA Lite™ MPO
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.
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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).
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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
510(K) SUMMARY OF SAFETY AND 9. EFFECTIVENESS
This summary of safety and effectiveness information is being submitted in This Summary of Safety and of The Safety Medical Devices Act of 1990 (SMDA 1990) and 21 CFR Part 807.92.
| Assigned 510(k) Number: | K041040 |
|---|---|
| Date of Summary Preparation: | April 20, 2004 |
| Manufacturer: | Pharmacia Deutschland GmbH, |
| Diagnostics Division | |
| Munzinger Strasse 7 | |
| D-79111 Freiburg, Germany | |
| Company Contact Person: | Michael Linss |
| Manager, Compliance & Quality | |
| Pharmacia Deutschland GmbH | |
| Diagnostics Division | |
| Munzinger Strasse 7 | |
| D-79111 Freiburg, Germany | |
| +49-761-47805-310(Phone) | |
| +49-761-47805-335 (Fax) | |
| Device Name: | Varelisa® MPO ANCA |
| Common Name: | myeloperoxidase anti neutrophil cytoplas- |
| matic antibodies immunological test system |
Classification
| Product Name | Product Code | Class | CFR |
|---|---|---|---|
| Varelisa® MPO ANCA | MOB | II | 866.5660 |
Substantial Equivalence to
INOVA QUANTA Lite™ MPO
1
Intended Use Statement
The Varelisa MPO ANCA EIA kit is designed for the semi-quantitative and The varensa mro of myeloperoxidase anti neutrophil cytoplasmatic antibodies (MPO ANCA) in human serum or plasma to aid in the diagnosis of antiooules (11) O Free vasculitides such as microscopic polyangiitis, and crescentic glomerulonephritis.
General Description of the New Device
Varelisa MPO ANCA is an indirect noncompetitive enzyme immunoassay for the semiquantitative and qualitative determination of MPO ANCA in human serum or plasma. Antibodies specific for MPO present in the patient sample bind to the antigen.
The test kit contains microplate strips coated with human purified MPO ANCA antigen, calibrators, positive and negative controls, enzyme-labeled conjugate, substrate and substrate stop solution, Sample Diluent and wash buffer.
Test Principle of the New Device
Varelisa MPO ANCA is an indirect noncompetitive enzyme immunoassay for the semiquantitative and qualitative determination of MPO ANCA in human serum or plasma. The wells of a microplate are coated with human purified MPO antigen. Antibodies specific for MPO present in the patient sample bind to the antigen.
In a second step the enzyme labeled second antibody (conjugate) binds to the antigen-antibody complex which leads to the formation of an enzyme labeled conjugate-antibody-antigen complex. The enzyme labeled antigen-antibody complex converts the added substrate to form a colored solution.
The rate of color formation from the chromogen is a function of the amount of conjugate complexed with the bound antibody and thus is proportional to the initial concentration of the respective antibodies in the patient sample.
Device Comparison
Both assays (the predicate and the new device) are indirect noncompetitive enzyme immunoassays for the semi-quantitative determination of IgG autoantibodies to myeloperoxidase (MPO) in human serum. Both assays recommend the same sample dilutions and use comparable enzyme-linked conjugates and antigens. Based on currently available data from the literature the measuring of the autoantibodies to MPO provides aid in the diagnosis of certain autoimmune vasculitides.
A difference between both assays is that the INOVA QUANTA Lite™ MPO is only recommended for use in serum specimen while the PHARMACIA Varelisa MPO ANCA is intended for use with serum and plasma. The cut-off in the INOVA QUANTA Lite™ MPO is evaluated by using a low and a high positive Standard and a grading of the results in negative, weak, moderate and strong positive. The PHARMACIA Varelisa MPO ANCA uses a set of six Calibrators and classifies the results as negative, equivocal and positive.
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Laboratory equivalence
The comparability of INOVA QUANTA Lite™ MPO and Pharmacia Varelisa MPO ANCA is supported by a data set including
- · results obtained within a comparison study analyzing positive, equivocal and negative sera.
- · results obtained for externally defined Calibrators and clinically defined sera.
- · results obtained for samples from apparently healthy subjects (normal population).
The data show that the assay performs as expected from the medical literature.
In summary, all available data support that the new device, PHARMACIA Varelisa MPO ANCA Assay is substantially equivalent to the predicate device, INOVA QUANTA Lite™ MPO Assay, and that the new device performs according to state-of-the-art expectations.
3
Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling three stylized human figures or waves, stacked on top of each other.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Michael Linss, Ph.D. Manager, Compliance & Quality Sweden Diagnostics (Germany) GmbH Munzinger Strasse 7 D-79111 Freiburg
JUN 1 6 2004
K041040 Trade/Device Name: Varelisa® MPO ANCA Regulation Number: 21 CFR § 866.5660 Regulation Name: Multiple Autoantibodies Immunological Test System Regulatory Class: II Product Code: MOB Dated: April 20, 2004 Received: April 23, 2004
Dear Dr. Linss:
Re:
We have reviewed your Section 510(k) premarket notification of intent to market the device w & Howean John and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for associoior 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must or any I vith all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); and good manufacturing practice OFF Part 820), as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 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.
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If you desire specific information about the application of labeling requirements to your device, If you desire specific information as advertising of your device, please contact the Office of In of questions on the promotion and Safety at (301) 594-3084. Also, please note the V III Diagnostic Dorio Branding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Tou may outlif other general messages and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
Joseph L. Arlott
Joseph L. Hackett, Ph.D. Acting Director Division of Immunology and Hematology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Indications for Use
5 l 0(k) Number: _____________________________________________________________________________________________________________________________________________________________
Device Name: Varelisa® MPO ANCA
Indications For Use:
The Varelisa MPO ANCA EIA kit is designed for the semi-quantitative and The Valensa NY O TIYOF Enternations anti neutrophil cytoplasmatic antibodies (MPO ANCA) in human serum or plasma to aid in the diagnosis of certain (MI O ANCA) in haman berain as microscopic polyangiitis, and crescentic glomerulonephritis.
Marie M Chan
Division Sign-Off
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K041640
Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Per 21 CFR 801.109)
(21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)