(71 days)
Inova Quanta Lite™ PR-3
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No
The summary describes a standard enzyme immunoassay kit and does not mention any AI or ML components.
No
This device is an in vitro diagnostic test designed to detect antibodies to aid in the diagnosis of a condition, not to treat or directly manage a disease or condition.
Yes.
The "Intended Use / Indications for Use" states that the kit is "to aid in the diagnosis of Wegener's granulomatosis," indicating its role in identifying a medical condition.
No
The device description clearly states it is an enzyme immunoassay kit containing physical components like microplate strips, calibrators, controls, and solutions, indicating it is a hardware-based diagnostic test kit, not software only.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states that the kit is designed for the "semi-quantitative and qualitative determination of proteinase 3 anti neutrophil cytoplasmic antibodies (PR3 ANCA) in human serum or plasma to aid in the diagnosis of Wegener's granulomatosis." This involves testing human biological samples (serum or plasma) outside of the body to provide information for diagnostic purposes.
- Device Description: The description details a test kit containing reagents and components used to perform an "indirect noncompetitive enzyme immunoassay" on human serum or plasma. This is a typical format for an in vitro diagnostic test.
The definition of an IVD is a medical device that is used to perform tests on samples such as blood, urine, or tissue, to detect diseases or other conditions. This device clearly fits that definition.
N/A
Intended Use / Indications for Use
The Varelisa PR3 ANCA EIA kit is designed for the semi-quantitative and qualitative determination of proteinase 3 anti neutrophil cytoplasmic antibodies (PR3 ANCA) in human serum or plasma to aid in the diagnosis of Wegener's granulomatosis.
Product codes
MOB
Device Description
Varelisa PR3 ANCA is an indirect noncompetitive enzyme immunoassay for the semiquantitative and qualitative determination of PR3 ANCA in human serum or plasma.
The test kit contains microplate strips coated with human purified PR3 antigen, calibrators, positive and negative controls, enzyme-labeled conjugate, substrate and substrate stop solution, sample diluent and wash buffer.
Varelisa PR3 ANCA is an indirect noncompetitive enzyme immunoassay for the semiquantitative and qualitative determination of PR3 ANCA in human serum or plasma. The wells of a microplate are coated with human PR3 antigen, Antibodies specific for PR3 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.
Mentions image processing
Not Found
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
The comparability of QUANTA Lite™ PR-3 and Varelisa PR3 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).
Key Metrics
Not Found
Predicate Device(s)
INOVA QUANTA Lite™ PR-3
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).
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510(K) SUMMARY OF SAFETY AND 9. EFFECTIVENESS
This summary of safety and effectiveness information is being submitted in accordance with the requirements of The Safety Medical Devices Act of 1990 (SMDA 1990) and 21 CFR Part 807.92.
| Assigned 510(k) Number: | K041043 |
|---|---|
| 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 and 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 PR3 ANCA |
| Common Name: | test system, antineutrophil cytoplasmic |
| antibodies (anca) | |
| Classification |
Classification
| Product Name | Product Code | Class | CFR |
|---|---|---|---|
| Varelisa PR3 ANCA | MOB | II | 866.5660 |
Substantial Equivalence to
INOVA QUANTA Lite™ PR-3
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Intended Use Statement
The Varelisa PR3 ANCA EIA kit is designed for the semi-quantitative and qualitative determination of proteinase 3 anti neutrophil cytoplasmic antibodies (PR3 ANCA) in human serum or plasma to aid in the diagnosis of Wegener's granulomatosis.
General Description of the Device
Varelisa PR3 ANCA is an indirect noncompetitive enzyme immunoassay for the semiquantitative and qualitative determination of PR3 ANCA in human serum or plasma.
The test kit contains microplate strips coated with human purified PR3 antigen, calibrators, positive and negative controls, enzyme-labeled conjugate, substrate and substrate stop solution, sample diluent and wash buffer.
Varelisa® PR3 ANCA Test Principle
Varelisa PR3 ANCA is an indirect noncompetitive enzyme immunoassay for the semiquantitative and qualitative determination of PR3 ANCA in human serum or plasma. The wells of a microplate are coated with human PR3 antigen, Antibodies specific for PR3 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 and qualitative determination of IgG autoantibodies to protease 3 (PR3) 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 PR3 provides aid in the diagnosis of Wegener's granulomatosis.
A difference between both assays is that the INOVA QUANTA Lite™ PR-3 is only recommended for use in serum specimen while the PHARMACIA Varelisa PR3 ANCA is intended for use with serum and plasma. The cut-off in the INOVA QUANTA Lite™ PR-3 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 PR3 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 QUANTA Lite™ PR-3 and Varelisa PR3 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 PR3 ANCA is substantially equivalent to the predicate device, INOVA QUANTA Lite™ PR-3, and that the new device performs according to state-ofthe-art expectations.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like figure with three curved lines representing its body and wings. The logo is surrounded by text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" in a circular arrangement.
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
JUL - 2 2004
Mr. Michael Linss Manager, Compliance and Quality Pharmacia Deutschland GmgH Diagnostics Division Munzinger Strasse 7 D-79111 Freiburg, Germany
K041043 Re: Trade/Device Name: Varelisa® PR3 ANCA Regulation Number: 21 CFR 866.5660 Regulation Name: Multiple autoantibodies immunological test system Regulatory Class: Class II Product Code: MOB Dated: April 20, 2004 Received: April 23, 2004
Dear Mr. Linss:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above 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 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) 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 comply with 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 requirements 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
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If you desire specific information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 594-3084. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International 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,
Robert L. Becker, Jr.
Robert L. Becker, Jr., M.D., Ph. 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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Varelisa® PR3 ANCA - New Device 510(k) Submission Section 1. Indications for Use Statement
510(k) Number: _______________________________________________________________________________________________________________________________________________________________
Device Name: Varelisa® PR3 ANCA
Intended Use Statement
The Varelisa PR3 ANCA EIA kit is designed for the semiquantitative and qualitative The Varensa FRS ANCA Elli neutrophil cytoplasmic antibodies (PR3 ANCA) in human serum or protemase -> and notal of Wegener's granulomatosis.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|---|---|
| Prescription Use | ✓ |
| (Per 21 CFR 801.109) | |
| OR | |
| Over-The-Counter Use | |
| Thane Chan | |
| Division Sign-Off | |
| Office of In Vitro Diagnostic Device |
Evaluation and Safety
510(k)________________________________________________________________________________________________________________________________________________________________________