(81 days)
The Varelisa B2-Glycoprotein I IgG Antibodies EIA kit is designed for the semiguantitative and qualitative determination of ß2-glycoprotein I IgG 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.
Varelisa B .- Glycoprotein I IgG Antibodies Assay is an indirect The noncompetitive enzyme immunoassay for the semiquantitative and qualitative determination of ß2-glycoprotein I IgG 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.
The provided text describes the Varelisa® ß2 Glycoprotein I IgG Antibodies EIA kit and its comparison to a predicate device, but it lacks specific acceptance criteria as quantitative thresholds and a detailed study report that explicitly states how these criteria were met.
However, based on the provided text, I can infer the implied acceptance criteria, the general nature of the study conducted, and the reported device performance.
Here's an analysis of the information requested, based on the text:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state numerical acceptance criteria. Instead, it focuses on the comparability to a predicate device and performance as expected from medical literature.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Substantial Equivalence to Predicate Device: | |
| - Comparable performance to INOVA QUANTA Lite™ ß2 GPI IgG Assay for semi-quantitative and qualitative determination of IgG antibodies against ß2-glycoprotein I in serum. | - "The comparability of QUANTA LiteTM B2 GPI IgG and Varelisa B2-Glycoprotein I IgG Antibodies is supported by a data set including results obtained within a comparison study analyzing positive, equivocal and negative sera."- "Corresponding performance data show the comparability of the results" (referring to OD-cutoff vs. decision point method for evaluation).- "All available data support that the new device...is substantially equivalent to the predicate device." |
| Suitability for Intended Use (Serums & Plasma): | |
| - Effective for use with serum samples. | - "The data show that the assay performs as expected from the medical literature." |
| - Effective for use with plasma samples. | - "Corresponding performance data underline the effectiveness of the assay with plasma as sample."- "The data show that the device is suitable for serum and plasma samples." |
| Accuracy/Reliability (General): | |
| - Performs as expected from medical literature. | - "The data show that the assay performs as expected from the medical literature."- "The new device performs according to state-of-the-art expectations." |
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Not explicitly stated. The text mentions "a comparison study analyzing positive, equivocal and negative sera" and "results obtained for samples from apparently healthy subjects (normal population)," but no specific numbers of samples are provided for these test sets.
- Data Provenance: Not explicitly stated. The manufacturer is based in Germany (Pharmacia Deutschland GmbH), suggesting the study could have been conducted in Germany, but this is not confirmed. It is a retrospective or prospective study is not mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not provided in the document. The method for establishing ground truth for the comparison study is not detailed.
4. Adjudication method for the test set
This information is not provided in the document.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
An MRMC study is not applicable here. This device is an in vitro diagnostic (IVD) immunoassay kit for laboratory analysis, not an AI-assisted diagnostic tool that helps human readers (e.g., radiologists) interpret images. Therefore, the concept of "human readers improve with AI vs without AI assistance" does not apply.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This concept is not applicable as it's an IVD kit, not an algorithm that operates independently without human interaction (even lab technicians are "in the loop" for running the test and interpreting the results within the context of the patient's clinical picture). The device itself is the "standalone" diagnostic tool in a lab setting, providing a semi-quantitative or qualitative result.
7. The type of ground truth used
The type of ground truth is implied to be clinical diagnosis or established antibody status. The mention of "positive, equivocal and negative sera" suggests that the samples had a pre-determined status based on clinical findings, other laboratory tests, or established reference standards for ß2-glycoprotein I IgG antibodies. The intended use statement also highlights its role "in conjunction with clinical findings and other laboratory tests to aid in the diagnosis," which points towards clinical correlation as the ultimate ground truth.
8. The sample size for the training set
This information is not provided in the document. The document describes a comparison study, but not a distinct "training set" in the context of machine learning or algorithm development. The development of the immunoassay itself would involve internal validation and optimization, but the term "training set" is not used or detailed.
9. How the ground truth for the training set was established
As no training set is explicitly mentioned, how its ground truth was established is not discussed in the document.
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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: | K040449 |
|---|---|
| Date of Summary Preparation: | February 12, 2004 |
| Manufacturer: | Pharmacia Deutschland GmbH,Diagnostics DivisionMunzinger Strasse 7D-79111 Freiburg, Germany |
| Company Contact Person: | Michael LinssManager, Regulatory AffairsPharmacia Deutschland GmbHDiagnostics DivisionMunzinger Strasse 7D-79111 Freiburg, Germany+49-761-47805-310(Phone)+49-761-47805-120 (Fax) |
| Device Name: | Varelisa® ẞ2 Glycoprotein I IgG Antibodies |
| Common Name: | ẞ2 Glycoprotein I autoantibodyimmunological test system |
Classification:
| Product Name | Product Code | Class | CFR |
|---|---|---|---|
| Varelisa® B2 Glycoprotein IIgG Antibodies | MSV | II | 866.5560 |
Substantial Equivalence toINOVA QUANTA LITE™ ß2 GPI (IgG) Antibodies
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Intended Use Statement
The Varelisa ß2-Glycoprotein I IgG Antibodies EIA kit is designed for the semiquantitative and qualitative determination of ß2-glycoprotein I IgG 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
Varelisa B .- Glycoprotein I IgG Antibodies Assay is an indirect The noncompetitive enzyme immunoassay for the semiquantitative and qualitative determination of ß2-glycoprotein I IgG 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 IgG Antibodies Test Principle
Varelisa ß2-Glycoprotein I IgG Antibodies is an indirect noncompetitive enzyme immunoassay for the semiquantitative and qualitative determination of ß2glycoprotein I IgG antibodies in human serum or plasma. The wells of a microplate are coated with human purified ß2-glycoprotein I antigen. Antibodies specific for ß2-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
Both assays (the predicate and the new device) are indirect noncompetitive enzyme immunoassays for the semiquantitative and qualitative determination of 1gG antibodies against ß2-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 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 IgG is only recommended for use in serum specimen while the PHARMACIA Varelisa B2-glycoprotein I IgG 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 IgG assay is evaluated by using the decision point method. PHARMACIA Varelisa B2-glycoprotein I IgG Antibodies assay uses an ODcutoff for evaluation. Corresponding performance data show the comparability of the results.
Laboratory equivalence
The comparability of QUANTA LiteTM B2 GPI IgG and Varelisa B2-Glycoprotein I IgG 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 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 IgG Antibodies Assay is substantially equivalent to the predicate device, INOVA QUANTA Lite™ ß2 GPI IgG 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 stylized eagle with three lines representing its body and wings. The eagle is facing right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the eagle.
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
K040449 Re:
Trade/Device Name: Varelisa® ß2 Glycoprotein I IgG 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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Page 2
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. Arbolett
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 IgG Antibodies- New Device 510(k) Submission Section 1. Indications for Use Statement
8040449 ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------510(k) Number:
Device Name: Varelisa® ß2 Glycoprotein I IgG Antibodies
Intended Use Statement
The Varelisa B2-Glycoprotein I IgG Antibodies EIA kit is designed for the semiguantitative and qualitative determination of ß2-glycoprotein I IgG 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.
Maria Chan
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K040449
(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)
§ 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).