(29 days)
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No
The summary describes a standard enzyme immunoassay (EIA) kit for antibody detection. There is no mention of AI, ML, or any computational analysis beyond standard assay interpretation.
No.
The device is an in-vitro diagnostic (IVD) kit used for qualitative determination of antibodies to aid in the diagnosis of a condition, not to treat it.
Yes
The device aids in the diagnosis of antiphospholipid syndrome (APS) and evaluates thrombotic risk, fulfilling the definition of a diagnostic device.
No
The device description clearly states it is an "indirect noncompetitive enzyme immunoassay," which is a laboratory test method involving physical reagents and processes, not solely 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 antibodies against cardiolipin in serum or plasma to aid in the diagnosis of antiphospholipid syndrome (APS) and to evaluate the thrombotic risk in patients with systemic lupus erythematosus (SLE)." This involves testing biological samples (serum or plasma) in vitro (outside the body) to provide diagnostic information.
- Device Description: The description confirms it's an "indirect noncompetitive enzyme immunoassay for the qualitative determination of antibodies against cardiolipin in serum or plasma." This further reinforces that it's a test performed on biological samples in vitro.
The core function of the device is to analyze a biological sample (serum or plasma) to detect specific substances (cardiolipin antibodies) for diagnostic purposes, which is the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Varelisa Cardiolipin Antibodies Screen EIA kit is designed for the qualitative determination of antibodies against cardiolivin in serum or plasma to aid in the diagnosis of antiphospholipid syndrome (APS) and to evaluate the thrombotic risk in patients with systemic lupus erythematosus (SLE).
Product codes (comma separated list FDA assigned to the subject device)
82MID
Device Description
The Varelisa Cardiolipin Antibodies Screen is an indirect noncompetitive enzyme immunoassay for the qualitative determination of antibodies against cardiolipin in serum or plasma.
Anti-cardiolipin antibodies (ACA) belong to the group of anti-phospholipid antibodies (aPL). ACA are considered to be of significant diagnostic relevance, as a correlation has been found between these antibodies and a tendency towards thromboses. This results in an increased incidence of venous/arterial thromboses (including apoplexy), thrombocytopenia, livedo reticularis, habitual abortion and neurological manifestations in ACA/LA-positive patients. Elevated levels of ACA may also be found in patients with cerebrovascular insufficiency or myocardial infarction, aPL plays a direct role in the pathogenesis of APS.
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 the new and the old version Varelisa Cardiolipin 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. Differing results are probably due to the changed blocking procedure.
In summary, all available data support that the new/modified device, Varelisa Cardiolipin Antibodies Screen Assay is substantially equivalent to the predicate/original device, Varelisa Cardiolipin Antibodies Screen Assay, and that the new/modified device performs according to state-of-the-art expectations.
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.
Varelisa® Cardiolipin Antibodies Screen
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).
0
510(K) SUMMARY OF SAFETY AND EFFECTIVENESS 9.
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: | K023433 |
|---|---|
| Date of Summary Preparation: | September 30, 2002 |
| Distributor: | Pharmacia |
| Diagnostics Division, US Operation | |
| 7425-248-1 | |
| 7000 Portage Road | |
| Kalamazoo, MI 49001 | |
| 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® Cardiolipin Antibodies Screen |
| Common Name: | Cardiolipin autoantibody immunological test |
| system |
| Product Name | Product Code | Class | CFR |
|---|---|---|---|
| Varelisa® Cardiolipin Antibodies | |||
| Screen | 82MID | II | 866.5560 |
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Substantial Equivalence to:
Varelisa® Cardiolipin Antibodies Screen
Intended Use Statement
The Varelisa Cardiolipin Antibodies Screen EIA kit is designed for the qualitative determination of antibodies against cardiolivin in serum or plasma to aid in the diagnosis of antiphospholipid syndrome (APS) and to evaluate the thrombotic risk in patients with systemic lupus erythematosus (SLE).
General Description of the Device
The Varelisa Cardiolipin Antibodies Screen is an indirect noncompetitive enzyme immunoassay for the qualitative determination of antibodies against cardiolipin in serum or plasma.
Anti-cardiolipin antibodies (ACA) belong to the group of anti-phospholipid antibodies (aPL). ACA are considered to be of significant diagnostic relevance, as a correlation has been found between these antibodies and a tendency towards thromboses. This results in an increased incidence of venous/arterial thromboses (including apoplexy), thrombocytopenia, livedo reticularis, habitual abortion and neurological manifestations in ACA/LA-positive patients. Elevated levels of ACA may also be found in patients with cerebrovascular insufficiency or myocardial infarction, aPL plays a direct role in the pathogenesis of APS.
Varelisa® Cardiolipin Antibodies Screen Test Principle
Varelisa Cardiolipin Antibodies Screen is an indirect noncompetitive enzyme immunoassay for the semiquantitative and qualitative determination of cardiolipin antibodies in human serum or plasma. The wells of a microplate are coated with bovine cardiolipin antigen. Antibodies specific for cardiolipin present in the patient sample bind to the antigen.
In a second step an enzyme labeled second antibody (Conjugate) binds to the antigenantibody complex which leads to the formation of an enzyme labeled antigenantibody sandwich 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.
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Device Comparison
Varelisa Cardiolipin Antibodies Screen (the original/predicate device) and Varelisa Cardiolipin Antibodies Screen (the new/modified device) both are indirect noncompetitive enzyme immunoassays for qualitative determination of antibodies against Cardiolipin in serum or plasma.
Based on currently available data from the literature the measuring of these antibodies not only provides aid in the evaluation of the thrombotic risk in patients with systemic lupus erythematosus, but also aids in the diagnosis of the antiphospholipid syndrome (APS). Thus the intended use of Varelisa Cardiolipin Antibodies Screen was adapted to the current state of scientific knowledge.
The essential differences between both assays are the new choice of antigen supplier and a changed blocking procedure.
Important common features between old and new version are the nature of the antigen determining the specificity of the assay, Bovine Cardiolipin, and the presence of B2glycoprotein I in the blocking buffer.
Laboratory equivalence
The comparability of the new and the old version Varelisa Cardiolipin 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. Differing results are probably due to the changed blocking procedure.
In summary, all available data support that the new/modified device, Varelisa Cardiolipin Antibodies Screen Assay is substantially equivalent to the predicate/original device, Varelisa Cardiolipin Antibodies Screen Assay, and that the new/modified 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 seal for the Department of Health & Human Services USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. In the center of the seal is an abstract symbol that resembles three stylized human profiles.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
NOV 1 3 2002
Mr. Michael Linss Manager, Regulatory Affairs Pharmacia Deutschland GmbH Diagnostics Division Munzinger Strasse 7 D-79111 Freiburg, Germany
Re: K023433
Trade/Device Name: Varelisa® Cardiolipin Antibodies Screen Regulation Number: 21 CFR 866.5660 Regulation Name: Multiple Autoantibodies Immunological Test System Regulatory Class: Class II Product Code: MID Dated: October 11, 2002 Received: October 15, 2002
Dear Mr. 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. Iisting 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 the Code of Federal Regulations, Title 21, Parts 800 to 898. 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 Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2 -
This letter will allow you to begin marketing your device as described in your 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 advice for your device on our labeling regulation (21 CFR Part 801 and ' additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained 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,
Steven Sutman
Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Varelisa® Cardiolipin Antibodies Screen - Device Modification 510(k) Submission Section 1. Indications for Use Statement
510(k) Number:
Koas 433
Device Name: Varelisa® Cardiolipin Antibodies Screen
Intended Use Statement
The Varelisa Cardiolipin Antibodies Screen EIA kit is designed for the qualitative determination of cardiolipin antibodies in serum or plasma to aid in the diagnosis of antiphospholipid syndrome (APS) and to evaluate the thrombotic risk in patients with systemic lupus erythematosus (SLE).
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
OR
Prescription Use /
Over-The-Counter Use
(Per 21 CFR 801.109)
| (Division Sign-Off) | |
|---|---|
| Division of Clinical Laboratory Devices | |
| 510(k) Number | C023933 |
CLS1.doc