(46 days)
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No
The description details a standard enzyme immunoassay (EIA) kit, which relies on chemical reactions and colorimetric detection, not AI/ML algorithms for analysis or interpretation. There are no mentions of AI, ML, or related concepts in the provided text.
No
The device is an in-vitro diagnostic (IVD) test that aids in diagnosis rather than providing therapy.
Yes
The device is intended "to aid in the diagnosis of systemic lupus erythematosus (SLE) or druginduced lupus erythematosus (DIL)" by detecting antibodies in patient samples. This function directly supports the diagnostic process.
No
The device description clearly outlines a physical kit with components like microtiter plates, antigens, and enzyme-labeled antibodies, indicating it is a hardware-based diagnostic assay, 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 "semiquantitative and qualitative determination of IgG and IgM antibodies to histone in serum or plasma to aid in the diagnosis of systemic lupus erythematosus (SLE) or druginduced lupus erythematosus (DIL)." This clearly indicates that the device is used to examine specimens derived from the human body (serum or plasma) to provide information for diagnostic purposes.
- Device Description: The description details an "indirect noncompetitive enzyme immunoassay" that uses human serum or plasma samples to detect antibodies. This process is performed in vitro (outside of the living organism).
- Mechanism: The mechanism described involves binding antibodies in the patient sample to an antigen on a microtiter plate, followed by the addition of an enzyme-labeled conjugate and a substrate to produce a colored solution. This is a standard in vitro diagnostic technique.
The core function of the device is to analyze a human biological sample in vitro to provide information relevant to a medical diagnosis. This aligns perfectly with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Varelisa Histone Antibodies EIA kit is designed for the semiquantitative and qualitative determination of IgG and IgM antibodies to histone in serum or plasma to aid in the diagnosis of systemic lupus erythematosus (SLE) or druginduced lupus erythematosus (DIL).
Product codes (comma separated list FDA assigned to the subject device)
LJM
Device Description
Varelisa Histone Antibodies is an indirect noncompetitive enzyme immunoassay for the semiquantitative and qualitative determination of histone antibodies in human serum or plasma. Antibodies specific for histones present in the patient sample bind to the antigen.
The test kit contains microplate strips coated with purified human histone antigen, calibrators, positive and negative controls, enzyme-labeled conjugate, substrate and substrate stop solution, sample diluent and wash buffer.
Varelisa Histone Antibodies is an indirect noncompetitive enzyme immunoassay for the semiquantitative and qualitative determination of histone antibodies in human serum or plasma. The wells of a microtiterplate are coated with human histone antigen. Antibodies specific for histones 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 INOVA QUANTA Lite™ Histone IgG and Varelisa Histone IgM/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.
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.
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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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§ 866.5100 Antinuclear antibody immunological test system.
(a)
Identification. An antinuclear antibody immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the autoimmune antibodies in serum, other body fluids, and tissues that react with cellular nuclear constituents (molecules present in the nucleus of a cell, such as ribonucleic acid, deoxyribonucleic acid, or nuclear proteins). The measurements aid in the diagnosis of systemic lupus erythematosus (a multisystem autoimmune disease in which antibodies attack the victim's own tissues), hepatitis (a liver disease), rheumatoid arthritis, Sjögren's syndrome (arthritis with inflammation of the eye, eyelid, and salivary glands), and systemic sclerosis (chronic hardening and shrinking of many body tissues).(b)
Classification. Class II (performance standards).
0
510(K) SUMMARY OF SAFETY AND MAY 1 4 2004 9. EFFECTIVENESS
This summary of safety and effectiveness information is being submitted in Fills ballinary of or execuirements of The Safety Medical Devices Act of 1990 (SMDA 1990) and 21 CFR Part 807.92.
:
| Assigned 510(k) Number: | K040810 |
|---|---|
| Date of Summary Preparation: | March, 17 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® Histone Antibodies |
| Common Name: | Histone antinuclear autoantibody |
| immunological test system |
Classification
| Product Name | Product Code | Class | CFR |
|---|---|---|---|
| Varelisa® Histone Antibodies | LJM | II | 866.5100 |
Substantial Equivalence to
INOVA QUANTA Lite™ Histone
1
Intended Use Statement
The Varelisa Histone Antibodies EIA kit is designed for the semiquantitative and qualitative determination of IgG and IgM antibodies to histone in serum or plasma to aid in the diagnosis of systemic lupus erythematosus (SLE) or druginduced lupus erythematosus (DIL).
General Description of the Device
Varelisa Histone Antibodies is an indirect noncompetitive enzyme immunoassay for the semiquantitative and qualitative determination of histone antibodies in human serum or plasma. Antibodies specific for histones present in the patient sample bind to the antigen.
The test kit contains microplate strips coated with purified human histone antigen, calibrators, positive and negative controls, enzyme-labeled conjugate, substrate and substrate stop solution, sample diluent and wash buffer.
Varelisa® Histone Antibodies Test Principle
Varelisa Histone Antibodies is an indirect noncompetitive enzyme immunoassay for the semiquantitative and qualitative determination of histone antibodies in human serum or plasma. The wells of a microtiterplate are coated with human histone antigen. Antibodies specific for histones 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 determination of antibodies against Histone in serum. Both assays recommend the same sample dilutions and use comparable antigens and detection systems.
In accordance to the relevant scientific literature both assays state in the Intended Use, that the measuring of the antibodies against histone provides aid in the diagnosis of systemic lupus erythematosus (SLE) or drug-induced lupus erythematosus (DIL).
A difference between both assays is that the INOVA QUANTA Lite™ Histone IgG is only recommended for use in serum specimen while the PHARMACIA Varelisa Histone Antibodies is, besides a limitation given for the use of plasma preparations with heparin, intended for use with serum and plasma.
The Varelisa Histone Antibodies is directed against Anti-Histone IgG and IgM antibodies while the predicate device detects Anti-Histone IgG antibodies only.
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The cut-off in the INOVA QUANTA Lite™ Histone IgG assay is evaluated by using a low and a high positive Standard and a grading of the results in negative, weak, moderate and strong positive. PHARMACIA Varelisa Histone Antibodies assay uses a set of six Calibrators and classifies the results as negative, equivocal and positive.
Laboratory equivalence
The comparability of INOVA QUANTA Lite™ Histone IgG and Varelisa Histone IgM/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.
In summary, all available data support that the new device, PHARMACIA Varelisa Histone IgM/IgG Antibodies Assay is substantially equivalent to the predicate device. INOVA QUANTA Lite™ Histone IgG Assay, and that the new device performs according to state-of-the-art expectations.
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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" arranged around the perimeter. Inside the circle is an abstract symbol resembling three stylized human profiles facing to the right, with flowing lines suggesting movement or progress.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
MAY 1 4 2004
Michael Linss, Ph.D. Manager, Compliance & Quality Pharmacia Deutschland GMBH Munzinger Strasse 7 Freiburg. Germany D 79111
K040810 Trade/Device Name: Varelisa® Histone Antibodies Regulation Number: 21 CFR 866.5100 Regulation Name: Antinuclear antibody immunological test system Regulatory Class: Class II Product Code: LJM Dated: March 19, 2004 Received: March 29, 2004
Dear Dr. Linss:
Re:
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 Fedcral 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. 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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510(k) Number: _______________________________________________________________________________________________________________________________________________________________
Device Name: Varelisa® Histone Antibodies
Intended Use Statement
The Varelisa Histone Antibodies EIA kit is designed for the semiquantitative and qualitative determination of IgG and IgM antibodies to histome in serum or plasma to lugus qualifative determination of Igo and Igni and Outs (SLE) or drug-induced lupus erythematosus (DIL).
. .
(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) | |
|---|---|
| Division Sign-Off | Mara Chan |
Office of In Vitro Diagnostic Device Evaluation and Safety