(81 days)
INOVA QUANTA Lite™ B2 GPI Screen
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No
The device description and performance studies describe a standard enzyme immunoassay (EIA) kit, which is a laboratory test based on chemical reactions, not AI/ML. There are no mentions of AI, ML, or related concepts.
No
The device is an in vitro diagnostic (IVD) kit used to detect specific antibodies in patient samples to aid in the diagnosis of certain conditions, not to treat or prevent disease.
Yes
This device is designed for the qualitative determination of B2-Glycoprotein I antibodies in human serum or plasma to aid in the diagnosis of thrombotic disorders and other autoimmune diseases. This function directly supports the diagnosis of medical conditions.
No
The device description clearly states that the kit contains physical components such as microplate strips, calibrator, controls, conjugate, substrate, and buffers, indicating it is a physical assay kit, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's for the "qualitative determination of B2-Glycoprotein I antibodies in human serum or plasma." This involves testing a sample taken from the human body in vitro (outside the body).
- Purpose: The purpose is to "aid in the diagnosis of thrombotic disorders related to the primary Antiphospholipid Syndrome or occurring secondary to systemic lupus erythematosus (SLE) or other autoimmune diseases." This is a diagnostic purpose.
- Device Description: The device is a "noncompetitive enzyme immunoassay" that uses "microplate strips coated with human purified ß2glycoprotein I," "calibrator, negative control, enzyme-labeled conjugate, substrate and substrate stop solution, buffered diluent and wash buffer." These are all components typical of an in vitro diagnostic test kit designed to analyze biological samples.
The combination of analyzing a human sample in vitro for a diagnostic purpose clearly identifies this device as an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Varelisa 32-Glycoprotein I Antibodies Screen EIA kit is designed for the qualitative determination of β2-Glycoprotein I antibodies in human serum or plasma. The presence of B2-glycoprotein I antibodies can be used in conjunction with clinical findings and other laboratory tests to aid in the diagnosis of thrombotic disorders related to the primary Antiphospholipid Syndrome or occurring secondary to systemic lupus erythematosus (SLE) or other autoimmune diseases.
Product codes
MSV
Device Description
The Varelisa ß2-Glycoprotein I Antibodies Screen is an indirect noncompetitive enzyme immunoassay for the qualitative determination of antibodies against ß glycoprotein I in serum or plasma.
The test kit contains microplate strips coated with human purified ß2glycoprotein I. calibrator, negative control, enzyme-labeled conjugate, substrate and substrate stop solution, buffered 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
The comparability of INOVA QUANTA Lite™ ß2 GPI Screen and PHARMACIA Varelisa ß2-glycoprotein I Antibodies Screen 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. .
- · results obtained for samples from apparently healthy subjects (normal population).
The data show that the assay performs as expected from the medical literature. Furthermore the performance data show that the device is suitable for serum and plasma samples.
In summary, all available data support that the new device, PHARMACIA Varelisa B2-glycoprotein I Antibodies Screen Assay is substantially equivalent to the predicate device, INOVA QUANTA Lite™ ß2 GP1 Screen Assay, and that the new device performs according to state-of-the-art expectations.
Key Metrics
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Predicate Device(s)
INOVA QUANTA Lite™ B2 GPI Screen
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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ழ். 510(K) SUMMARY OF SAFETY AND 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: | K040452 |
|---|---|
| Date of Summary Preparation: | February 12, 2004 |
| Manufacturer: | Pharmacia Deutschland GmbH, |
| Diagnostics Division | |
| Munzinger Strasse 7 | |
| D-79111 Freiburg, Germany | |
| Company Contact Person: | Michael Linss |
| Manager, Regulatory Affairs | |
| Pharmacia Deutschland GmbH | |
| Diagnostics Division | |
| Munzinger Strasse 7 | |
| D-79111 Freiburg, Germany | |
| +49-761-47805-310(Phone) | |
| +49-761-47805-120 (Fax) | |
| Device Name: | Varelisa® B2-Glycoprotein I Antibodies Screen |
| Common Name: | B2-Glycoprotein I autoantibody |
| immunological test system |
Classification
| Product Name | Product Code | Class | CFR |
|---|---|---|---|
| -------------- | -------------- | ------- | ----- |
Varelisa® ß2-Glycoprotein I MSV ロ 866.5660 Antibodies Screen
Substantial Equivalence to
INOVA QUANTA Lite™ B2 GPI Screen
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Intended Use Statement
The Varelisa B .- Glycoprotein I Antibodies Screen EIA kit is designed for the qualitative determination of B2-Glycoprotein I antibodies in human serum or plasma.
The presence of B2-glycoprotein I antibodies can be used in conjunction with clinical findings and other laboratory tests to aid in the diagnosis of thrombotic disorders related to the primary Antiphospholipid Syndrome or occurring secondary to systemic lupus erythematosus (SLE) or other autoimmune diseases.
General Description of the Device
The Varelisa ß2-Glycoprotein I Antibodies Screen is an indirect noncompetitive enzyme immunoassay for the qualitative determination of antibodies against ß glycoprotein I in serum or plasma.
The test kit contains microplate strips coated with human purified ß2glycoprotein I. calibrator, negative control, enzyme-labeled conjugate, substrate and substrate stop solution, buffered diluent and wash buffer.
Varelisa® ß2-Glycoprotein I Antibodies Screen Test Principle
Varelisa B2-Glycoprotein I Antibodies Screen is an indirect noncompetitive enzyme immunoassay for the qualitative determination of B2-glycoprotein I (IgG/IgM/IgA) antibodies in human serum or plasma. The wells of a microplate are coated with B2-glycoprotein I. Antibodies specific for B2-glycoprotein I 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
INOVA QUANTA Lite™ ß2 GPI Screen (the predicate device) and PHARMACIA Varelisa B2-glycoprotein I Antibodies Screen (the new device) both are indirect noncompetitive enzyme immunoassays for qualitative detection of IgM, IgG and IgA antibodies against B2-glycoprotein I in 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 antibodies against ß2-glycoprotein I not only provides aid in the diagnosis of thrombotic disorders secondary to systemic lupus erythematosus or other autoimmune diseases, but also aids in the diagnosis of the primary
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antiphospholipid syndrome. Thus the intended use of Varelisa ß2-glycoprotein I Antibodies Screen was adapted to the current state of scientific knowledge. The corresponding literature is cited in the directions for use.
A difference between both assays is that the INOVA QUANTA Lite™ B2 GPI Screen is only recommended for use in serum specimen while the PHARMACIA Varelisa B2-glycoprotein I Antibodies Screen is outlined for use with serum and plasma. Corresponding performance data underline the effectiveness of the assay with plasma as sample. Minor differences between both assays are restricted to contents of buffers and stop solution. The INOVA QUANTA Lite™ B2 GPI Screen contains an additional assay control and the assay is evaluated by using the decision point method. PHARMACIA Varelisa B2-glycoprotein I Antibodies Screen assay uses an ODcut-off. Corresponding performance data show the comparability of the results.
Laboratory equivalence
The comparability of INOVA QUANTA Lite™ ß2 GPI Screen and PHARMACIA Varelisa ß2-glycoprotein I Antibodies Screen 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. .
- · results obtained for samples from apparently healthy subjects (normal population).
The data show that the assay performs as expected from the medical literature. Furthermore the performance data show that the device is suitable for serum and plasma samples.
In summary, all available data support that the new device, PHARMACIA Varelisa B2-glycoprotein I Antibodies Screen Assay is substantially equivalent to the predicate device, INOVA QUANTA Lite™ ß2 GP1 Screen Assay, and that the new device performs according to state-of-the-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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, resembling a bird-like shape.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
MAY 11 2004
Michael Linss, Ph.D. Manager, Compliance & Quality Pharmacia Deutschland GMBH Diagnostics Division Munzinger Strasse 7 Freiburg. Germany D-79111
Re: K040452
Trade/Device Name: Varelisa® ß2 Glycoprotein I Antibodies Screen Regulation Number: 21 CFR 866.5660 Regulation Name: Multiple autoantibodies immunological test system Regulatory Class: Class II Product Code: MSV Dated: April 27, 2004 Received: April 30, 2004
Dear Dr. 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).
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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.
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,
Joseph L. Hackett
Joseph L. Hackett, Ph.D. Acting Director Division of Immunology and Hematology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Varelisa® ß2-Glycoprotein I Antibodies Screen – New Device 510(k) Submission Section 1. Indications for Use Statement
510(k) Number:
Device Name: Varelisa® ß2-Glycoprotein I Antibodies Screen
Intended Use Statement
The Varelisa 32-Glycoprotein I Antibodies Screen EIA kit is designed for the qualitative determination of $2-Glycoprotein I antibodies in human serum or plasma. The presence of B2-glycoprotein I antibodies can be used in conjunction with clinical findings and other laboratory tests to aid in the diagnosis of thrombotic disorders related to the primary Antiphospholipid Syndrome or occurring secondary to systemic lupus erythematosus (SLE) or other autoimmune diseases.
Thana Chan
ion Sign-C
Office of In Vitro Diagnostic Device Evaluation and Safety
510(K) K040452
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
OR
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________
(Per 21 CFR 801.109)