(45 days)
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No
The description details a standard enzyme immunoassay (EIA) kit for detecting antibodies. There is no mention of AI, ML, or any computational analysis beyond standard assay interpretation.
No.
The device is an in vitro diagnostic test designed to detect autoantibodies. It is used to assist in diagnosis, not to treat a disease.
Yes
The device is described as assisting "in the diagnosis of systemic lupus erythematosus (SLE) and certain other rheumatic diseases," which is a diagnostic purpose.
No
The device description clearly states the kit contains physical components such as microplate strips, calibrators, controls, conjugate, substrate, and buffers, indicating it is a hardware-based immunoassay kit, not software only.
Based on the provided information, the Varelisa ssDNA Antibodies EIA kit is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's for the "determination of anti-single stranded DNA (ssDNA) autoantibodies in serum or plasma." Serum and plasma are biological specimens taken from the human body.
- Device Description: The description details a test kit containing reagents and a microplate for performing an assay on human serum or plasma samples.
- Nature of the Test: The test is an enzyme immunoassay designed to detect specific antibodies in a patient's sample, which is a classic characteristic of an in vitro diagnostic test.
- Purpose: The test assists in the diagnosis of diseases (systemic lupus erythematosus and other rheumatic diseases) by analyzing components of the patient's body fluids.
All these points align with the definition of an In Vitro Diagnostic device, which is used to examine specimens from the human body to provide information for diagnosis, monitoring, or screening.
N/A
Intended Use / Indications for Use
The Varelisa ssDNA Antibodies EIA kit is designed for the semiquantitative and qualitative determination of anti-single stranded DNA (ssDNA) autoantibodies in serum or plasma. In conjunction with the Varelisa dsDNA Antibodies kit it assists in the diagnosis of systemic lupus erythematosus (SLE) and certain other rheumatic diseases. The test is not definitive in isolation but has to be seen as one parameter in a multicriterion diagnostic process.
Product codes
LJM
Device Description
Varelisa ssDNA Antibodies is an indirect noncompetitive enzyme immunoassay for the semiquantitative and qualitative determination of ssDNA antibodies in human serum or plasma. Antibodies specific for ssDNA present in the patient sample bind to the antigen. The assay should be used in combination with the Varelisa dsDNA Antibodies.
The test kit contains microplate strips coated with synthetic ssDNA, calibrators, positive and negative controls, enzyme-labeled conjugate, substrate and substrate stop solution, Sample 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 QUANTA Lite™ ssDNA and Varelisa ssDNA 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
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Predicate Device(s)
INOVA QUANTA Lite™ ssDNA
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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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 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: | K040811 |
|---|---|
| Date of Summary Preparation: | March 19, 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® ssDNA Antibodies |
| Common Name: | ssDNA antinuclear antibody |
| immunological test system |
Classification
| Product Name | Product Code | Class | CFR |
|---|---|---|---|
| Varelisa® ssDNA Antibodies | LJM | II | 866.5100 |
Substantial Equivalence to
INOVA QUANTA Lite™ ssDNA
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Intended Use Statement
The Varelisa ssDNA Antibodies EIA kit is designed for the semiquantitative and qualitative determination of anti-single stranded DNA (ssDNA) autoantibodies in serum or plasma. In conjunction with the Varelisa dsDNA Antibodies kit it assists in the diagnosis of systemic lupus erythematosus (SLE) and certain other rheumatic diseases. The test is not definitive in isolation but has to be seen as one parameter in a multicriterion diagnostic process.
General Description of the Device
Varelisa ssDNA Antibodies is an indirect noncompetitive enzyme immunoassay for the semiquantitative and qualitative determination of ssDNA antibodies in human serum or plasma. Antibodies specific for ssDNA present in the patient sample bind to the antigen. The assay should be used in combination with the Varelisa dsDNA Antibodies.
The test kit contains microplate strips coated with synthetic ssDNA, calibrators, positive and negative controls, enzyme-labeled conjugate, substrate and substrate stop solution, Sample Diluent and wash buffer.
Varelisa® ssDNA Antibodies Test Principle
Varelisa ssDNA Antibodies is an indirect noncompetitive enzyme immunoassay for the semiquantitative and qualitative determination of ssDNA antibodies in human serum or plasma. The wells of a microtiterplate are coated with synthetic ssDNA. Antibodies specific for ssDNA 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 IgG antibodies against ssDNA in serum. Both assays recommend the same sample dilutions and use comparable enzyme-linked conjugates and antigens. For evaluation of the assay both recommend to use a compatible dsDNA kit from the corresponding manufacturer and give comparable interpretations of the result. In accordance to the relevant scientific literature both assays state in the Intended Use, that the measuring of the antibodies against ssDNA provides aid in the diagnosis of SLE and other rheumatic diseases.
A difference between both assays is that the predicate device is only recommended for use in serum specimen while the new device is outlined for use with serum and plasma.
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Laboratory equivalence
The comparability of QUANTA Lite™ ssDNA and Varelisa ssDNA 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 ssDNA Antibodies Assay is substantially equivalent to the predicate device, INOVA QUANTA Lite™ ssDNA 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 features a stylized caduceus, which is a symbol of medicine and health. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus.
MAY 1 3 2004
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Michael Linss, Ph.D. Manager, Compliance & Quality Pharmacia Deutschland GMBH Munzinger Strasse 7 Freiburg, Germany D 79111
K040811 Re: Trade/Device Name: Varelisa® ssDNA Antibodies Regulation Number: 21 CFR 866.5100 Regulation Name: Antinuclear antibody immunological test system Regulatory Class: Class II Product Code: LRM Dated: March 19, 2004 Received: March 29, 2004
Dear Dr. Linss:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your betermined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for aso stated in the encreativent of the enactment date of the Medical Device Amendments, or to conninered prior to may 20, 2011 accordance with the provisions of the Federal Food, Drug, de fices that hat o ocen require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The r ou may, dierelove, mains 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 your doviet to such additional controls. Existing major regulations affecting your device n may oc subject to back dades Federal Regulations (CFR), Parts 800 to 895. In addition, FDA ean or tound in fire announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean I lease be deviloed and itermination that your device complies with other requirements of the Act that + Drederal statutes and regulations administered by other Federal agencies. You must or any I vith 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 I ou may 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® ssDNA Antibodies -- New Device 510(k) Submission Section 1. Indications for Use Statement
510(k) Number:
510(k) Number: _______________________________________________________________________________________________________________________________________________________________
Device Name: Varelisa® ssDNA Antibodies
Intended Use Statement
The Varelisa ssDNA Antibodies EIA kit is designed for the semiquantitative and qualitative determination of anti-single stranded DNA (ssDNA) autoantibodies in serum or plasma. In conjunction with the Varelisa dsDNA Antibodies kit it assists in Scrain of plasmic in conic lupus erythematosus (SLE) and certain other rheumatic diseases. The test is not definitive in isolation but has to be seen as one parameter in a multicriterion diagnostic process.
(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 | __________ |
|---|---|
| ---------------------- | ------------ |
| Maria Chan | |
|---|---|
| Division Sign-Off |
Office of In Vitro Diagnostic Device Evaluation and SafetyKO40811 510(k)-