← Product Code [MSV](/submissions/IM/subpart-f%E2%80%94immunological-test-systems/MSV) · K040451

# VARELISA B2 GLYCOPROTEIN I IGM ANTIBODIES, MODELS 18848 AND 18896 (K040451)

_Pharmacia Deutschland GmbH · MSV · May 11, 2004 · Immunology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/MSV/K040451

## Device Facts

- **Applicant:** Pharmacia Deutschland GmbH
- **Product Code:** [MSV](/submissions/IM/subpart-f%E2%80%94immunological-test-systems/MSV.md)
- **Decision Date:** May 11, 2004
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 866.5660
- **Device Class:** Class 2
- **Review Panel:** Immunology

## Intended Use

The Varelisa B2-Glycoprotein I IgM Antibodies Kit is designed for the semiquantitative and qualitative determination of β2-glycoprotein I IgM antibodies in serum or plasma. The presence of β2-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 erythematosis (SLE) or other autoimmune diseases. Prescription use only.

## Device Story

Varelisa B2-Glycoprotein I IgM Antibodies is an indirect noncompetitive enzyme immunoassay (EIA) for detecting IgM antibodies against B2-glycoprotein I in human serum or plasma. The test utilizes microplate strips coated with purified human B2-glycoprotein I antigen. Patient samples are incubated; specific antibodies bind to the antigen. An enzyme-labeled conjugate is added, binding to the antigen-antibody complex. A substrate is introduced, producing a color change proportional to the concentration of bound antibodies. The assay is performed in a laboratory setting by trained personnel. Results are interpreted by healthcare providers alongside clinical findings and other laboratory tests to aid in diagnosing thrombotic disorders associated with Antiphospholipid Syndrome or autoimmune conditions like SLE. The device provides a diagnostic aid, potentially improving clinical management of thrombotic risks.

## Clinical Evidence

No clinical studies were performed. Analytical performance was established via bench testing, including precision (total CV < 15%), linearity, and interference testing (bilirubin, hemoglobin, chyle, rheumatoid factor). A method comparison study using 42 patient samples (SLE, lupus-like, AIDS, APS, healthy) demonstrated 90.5% qualitative agreement with the predicate device. Reference ranges were established using 432 healthy donors.

## Technological Characteristics

Indirect noncompetitive enzyme immunoassay (EIA). Components: microplate strips coated with human purified B2-glycoprotein I antigen, calibrators, controls, enzyme-labeled conjugate, substrate, stop solution, buffered diluent, and wash buffer. Analyte: B2-glycoprotein I IgM antibodies. Sample types: serum and plasma. Evaluation: OD-cutoff based.

## Regulatory 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).

## Predicate Devices

- INOVA QUANTA Lite™ ß2 GPI IgM

## Submission Summary (Full Text)

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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,<br>Diagnostics Division<br>Munzinger Strasse 7<br>D-79111 Freiburg, Germany                                                                                                       |
| Company Contact Person:      | Michael Linss<br>Manager, Regulatory Affairs<br>Pharmacia Deutschland GmbH<br>Diagnostics Division<br>Munzinger Strasse 7<br>D-79111 Freiburg, Germany<br>+49-761-47805-310(Phone)<br>+49-761-47805-120 (Fax) |
| Device Name:                 | Varelisa® B2-Glycoprotein I IgM Antibodies                                                                                                                                                                    |
| Common Name:                 | ß2-Glycoprotein I autoantibody<br>immunological test system                                                                                                                                                   |
| Classification               |                                                                                                                                                                                                               |

| Product Name                                  | Product Code | Class | CFR      |
|-----------------------------------------------|--------------|-------|----------|
| Varelisa® β2-Glycoprotein I<br>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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#### 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. 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)

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**Source:** [https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/MSV/K040451](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/MSV/K040451)

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