(81 days)
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No
The summary describes a standard enzyme immunoassay kit and does not mention any AI or ML components.
No
The device is an in-vitro diagnostic test for antibodies, used to aid in the diagnosis of thrombotic disorders. It does not directly treat or prevent any medical condition, which are characteristics of a therapeutic device.
Yes
The "Intended Use / Indications for Use" section explicitly states that the presence of the antibodies determined by the kit can be used "to aid in the diagnosis of thrombotic disorders."
No
The device description clearly states that the kit contains physical components such as microplate strips, calibrators, controls, conjugate, substrate, and buffers, indicating it is a hardware-based assay kit, 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 "semiquantitative and qualitative determination of ß2-glycoprotein I IgM antibodies in serum or plasma." Serum and plasma are biological samples taken in vitro (outside the body).
- Device Description: The device description details a kit containing components like microplate strips, calibrators, controls, conjugate, substrate, etc., which are typical components of an in vitro assay.
- Function: The device performs an enzyme immunoassay, which is a laboratory technique used to detect and measure substances in biological samples in vitro.
- Purpose: The results are used "in conjunction with clinical findings and other laboratory tests to aid in the diagnosis of thrombotic disorders," indicating its role in providing diagnostic information from in vitro testing.
All these points align with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Varelisa ß2-Glycoprotein I IgM Antibodies EIA kit is designed for the semiquantitative and qualitative determination of ß2-glycoprotein I IgM antibodies in serum or plasma.
The presence of ß2-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 (comma separated list FDA assigned to the subject device)
MSV
Device Description
The Varelisa B2-Glycoprotein I IgM Antibodies Assay is an indirect noncompetitive enzyme immunoassay for the semiquantitative and qualitative determination of B2-glycoprotein I IgM antibodies in serum or plasma.
The test kit contains microplate strips coated with human purified ß2glycoprotein I, calibrators, positive and negative controls, enzyme-labeled conjugate, substrate and substrate stop solution, buffered diluent and wash buffer.
Varelisa B2-Glycoprotein I IgM Antibodies is an indirect noncompetitive enzyme immunoassay for the semiquantitative and qualitative determination of B2-glycoprotein I IgM antibodies in human serum or plasma. The wells of a microplate are coated with human purified B2-glycoprotein I antigen. Antibodies specific for Bz-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.
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 QUANTA LiteTM ß2 GPI IgM and Varelisa B2-Glycoprotein I IgM Antibodies 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.
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™ ß2 GPI IgM
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).
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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: | K040451 |
|---|---|
| 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 IgM Antibodies |
| Common Name: | ß2-Glycoprotein I autoantibody |
| immunological test system | |
| Classification |
| Product Name | Product Code | Class | CFR |
|---|---|---|---|
| Varelisa® β2-Glycoprotein I | |||
| IgM Antibodies | MSV | II | 866.5560 |
Substantial Equivalence to
INOVA QUANTA Lite™ ß2 GPI IgM
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Intended Use Statement
The Varelisa B2-Glycoprotein I IgM Antibodies EIA kit is designed for the semiquantitative and qualitative determination of B2-glycoprotein I IgM antibodies in 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 B2-Glycoprotein I IgM Antibodies Assay is an indirect noncompetitive enzyme immunoassay for the semiquantitative and qualitative determination of B2-glycoprotein I IgM antibodies in serum or plasma.
The test kit contains microplate strips coated with human purified ß2glycoprotein I, calibrators, positive and negative controls, enzyme-labeled conjugate, substrate and substrate stop solution, buffered diluent and wash buffer.
Varelisa® ß2-Glycoprotein I IgM Antibodies Test Principle
Varelisa B2-Glycoprotein I IgM Antibodies is an indirect noncompetitive enzyme immunoassay for the semiquantitative and qualitative determination of B2-glycoprotein I IgM antibodies in human serum or plasma. The wells of a microplate are coated with human purified B2-glycoprotein I antigen. Antibodies specific for Bz-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
QUANTA LiteTM B2 GPI IgM (predicate device) and Varelisa B2-Glycoprotein I IgM Antibodies (new device) both are indirect noncompetitive enzyme immunoassays for semiquantitative and qualitative determination of IgM antibodies against ß2-Glycoprotein I in serum. Both assays recommend the same sample dilutions and use comparable antigens and enzyme-linked conjugates.
Based on currently available data from the literature the measuring of the antibodies against B2-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™ ß2 GPI IgM is only recommended for use in serum specimen while the PHARMACIA Varelisa B2-glycoprotein I IgM Antibodies 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 IgM assay is evaluated by using the decision point method. PHARMACIA Varelisa B2-glycoprotein I IgM Antibodies assay uses an ODcutoff for evaluation. Corresponding performance data show the comparability of the results.
Laboratory equivalence
The comparability of QUANTA LiteTM ß2 GPI IgM and Varelisa B2-Glycoprotein I IgM Antibodies 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 IgM Antibodies Assay is substantially equivalent to the predicate device, INOVA QUANTA Lite™ B2 GPI IgM 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 and Human Services. The logo features a stylized eagle with three tail feathers, representing the department's commitment to health, human services, and well-being. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
MAY 1 1 2004
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Michael Linss, Ph.D. Manager, Compliance & Quality Pharmacia Deutschland GMBH Diagnostics Division Munzinger Strasse 7 Freiburg, Germany D-79111
K040451 Rc:
Trade/Device Name: Varelisa® ß2 Glycoprotein I IgM Antibodies 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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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. Ardolett
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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Varelisa® ß2-Glycoprotein I IgM Antibodies - New Device 510(k) Submission Section 1. Indications for Use Statement
510(k) Number: KO40451
Device Name: Varelisa® ß2-Glycoprotein I IgM Antibodies
Intended Use Statement
The Varelisa ß2-Glycoprotein I IgM Antibodies EIA kit is designed for the semiquantitative and qualitative determination of ß2-glycoprotein I IgM antibodies in serum or plasma.
The presence of ß2-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.
Mari Chan
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K040451
(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)