FIDIS CONNECTIVE 10, MODEL MX006

K053653 · Biomedical Diagnostics (Bmd) SA · LLL · Mar 13, 2006 · Immunology

Device Facts

• Record ID: K053653
• Device Name: FIDIS CONNECTIVE 10, MODEL MX006
• Applicant: Biomedical Diagnostics (Bmd) SA
• Product Code: LLL · Immunology
• Decision Date: Mar 13, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.5100
• Device Class: Class 2

Intended Use

The FIDIS™ Connective 10* kit is a fluorescent immunoassay for the semi-quantitative simultaneous detection of 10 autoantibody specificities directed against double stranded DNA (dsDNA), SSA (60 kDA and 52 kDA), SSB, Sm, Sm/RNP, Scl-70, Jo-1 ribosome and centromere in human serum. (*Antibodies to dsDNA, SSA, SSB, Sm, Sm/RNP, Scl-70, Jo-1, ribosome and centromere can be reported using this assay). The test system is used to screen serum samples and detect the presence of antinuclear antibodies associated with connective diseases systemic lupus erythematosus (SLE), Sjogren's syndrome, mixed connective tissue disease (MCTD), scleroderma, dermatomyositis, and CREST syndrome, in conjunction with clinical findings and other laboratory tests.

Device Story

FIDIS™ Connective 10* is a multiplexed fluorescent immunoassay for semi-quantitative detection of 10 autoantibody specificities in human serum. Input: patient serum samples. Process: antigens (dsDNA, SSA, SSB, Sm, Sm/RNP, Scl-70, Jo-1, ribosome, centromere) are covalently coupled to color-coded microspheres; patient autoantibodies bind to immobilized antigens; phycoerythrin-labeled anti-human IgG conjugate binds to antibody-antigen complexes. Output: flow cytometric measurement of fluorescence intensity per bead set, interpolated against a calibration system to determine antibody titers. Used in clinical laboratories; operated by trained technicians. Results assist clinicians in screening for systemic autoimmune diseases in conjunction with other clinical findings.

Clinical Evidence

Bench testing only. Performance supported by comparison studies against predicate devices using positive, equivocal, and negative serum samples. Data included analysis of samples from apparently healthy subjects and samples with potential biological cross-reactivity.

Technological Characteristics

System includes FIDIS flow cytometer, XYP automatic sampling platform, SD pump, and MLX-BOOSTER software. Uses color-coded microspheres sensitized with specific antigens and phycoerythrin-conjugated anti-human IgG. Detection via flow cytometry fluorescence measurement. Fully integrated, automated immunodiagnostic system.

Indications for Use

Indicated for the semi-quantitative detection of autoantibodies (dsDNA, SSA 60kDa/52kDa, SSB, Sm, Sm/RNP, Scl-70, Jo-1, Ribosomes, Centromeres) in human serum to aid in the diagnosis of connective tissue diseases including SLE, Sjogren's syndrome, MCTD, scleroderma, dermatomyositis, polymyositis, and CREST syndrome. For professional, prescription use.

Regulatory Classification

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).

Predicate Devices

• Varelisa dsDNA antibodies (K950031)
• Varelisa RO (SS-A) antibodies (K944169)
• Varelisa LA (SS-B) antibodies (K944168)
• Varelisa SM antibodies (K042629)
• Varelisa RNP antibodies (K993589)
• Varelisa JO1 antibodies (K944169)
• Varelisa SCL-70 antibodies (K944172)
• Varelisa CENTROMERE antibodies (K944171)
• QuantaLite RIBOSOME P ELISA (K981237)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows a logo for "bmd biomedical diagnostics". The letters "bmd" are stacked on top of the words "biomedical diagnostics". There are three black water droplets underneath the letters "b", "m", and "d".

MAR 1 3 2006

Premarket Notification 510(k) Summary

# Assigned 510(k) Number: KOS 3653

## 1. Submitted by :

| Name: | Biomedical Diagnostics S.A (bmd) | |
|----------------------|-----------------------------------|--|
| Contact Person: | Christelle COURIVAUD | |
| | Regulatory Affairs Manager | |
| Address: | Actipole 25, 4-6 Bld de Beaubourg | |
| | 77435 Marne-La-Vallée Cedex 2 | |
| | FRANCE | |
| Telephone: | 33 (0)1 64 62 10 12 | |
| Fax: | 33 (0)1 64 62 09 66 | |
| Establishment | | |
| Registration Number: | 3003935253 | |

US Agent correspondent:

Hoppe Regulatory Consultants Ms P. Ann HOPPE 2335 Massey Lane Decatur GA 30033 USA Phone: [phone] E-mail: Hoppe [e-mail]

# 2. Device Name

| Trade/Proprietary Name : | FIDIS TM CONNECTIVE 10 |
|--------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Common/Usual Name : | MX006 - FIDISTM CONNECTIVE 10: Detection test of 10<br>autoantibody specificities: double stranded DNA (dsDNA),<br>SSA 60kDa, SSA 52kDa, SSB, Sm, Sm/RNP, Scl70, Jo-1,<br>Ribosomes and Centromeres. |
| Classification Name: | Immunology and Microbiology Devices |

## 3. Predicate Devices

| 510K Number | Device Classification Name | Manufacturer Name |
|-------------|--------------------------------|--------------------------|
| K950031 | Varelisa dsDNA antibodies | Sweden Diagnostics, GBMH |
| K944169 | Varelisa RO (SS-A) antibodies | Sweden Diagnostics, GBMH |
| K944168 | Varelisa LA (SS-B) antibodies | Sweden Diagnostics, GBMH |
| K042629 | Varelisa SM antibodies | Sweden Diagnostics, GBMH |
| K993589 | Varelisa RNP antibodies | Sweden Diagnostics, GBMH |
| K944173 | Varelisa JO1 antibodies | Sweden Diagnostics, GBMH |
| K944172 | Varelisa SCL-70 antibodies | Sweden Diagnostics, GBMH |
| K944171 | Varelisa CENTROMERE antibodies | Sweden Diagnostics, GBMH |
| K981237 | QuantaLite RIBOSOME P ELISA | INOVA Diagnostics, Inc |

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Registered Office : Actipole 25 4-6 bd de Beaubourg 77435 Marne La Vallée cedex 2

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Image /page/1/Picture/0 description: The image shows a logo for "biomedical diagnostics". The logo consists of the letters "bmd" in a stylized font, with the letters connected and sitting on top of a horizontal line. There are three black droplets or blobs of liquid underneath the letters, appearing to be dripping from the letters above. Below the line, the words "biomedical diagnostics" are written in a smaller, sans-serif font.

#### 4. Intended use of the device

The FIDIS™ CONNECTIVE 10* kit is a semi-quantitative homogeneous fluorescentbased microparticles immunoassays using flow cytometry readings. It is designed for the simultaneous detection of 10 autoantibody specificities: double stranded DNA (dsDNA), SSA 60kDa. SSA 52kDa. SSB, Sm, Sm/RNP, Scl70, Jo-1, Ribosomes and Centromeres.

(* antibodies to dsDNA, Sm, Sm/RNP, SS-A, SS-B, Scl70, Jo1, Ribosomes and Centromeres can be reported using this assay).

The test system is used to screen serum samples and detect the presence of anti-nuclear antibodies associated with connective diseases (systemic lupus erythematosus (SLE), Sjogren's syndrome, mixed connective tissues disease (MCTD) scleroderma, dermatomyositis, polymyositis and CREST syndrome).

## 5. Description of the Device

The assay kits consist of:

- a mixture of color-coded microspheres sensitized respectively by dsDNA, SSA 60kDa, SSA 52kDa, SSB, Sm, Sm/RNP, Scl70, Jo-1, Ribosomes and Centromeres.

- a ready to use anti-human IgG coupled to phycoerythrin,

- a ready to use calibrator titered for each specificity,

- a positive control IgG to be diluted.
- a negative control to be diluted,

- a 10X concentrated PBS-Tween.

Rk: Calibrators, positive and negative controls are diluted human sera.

## 6. Summary of the technological characteristics of the device compared to the predicate device

The FIDIS™ System is a fully integrated and automated system for immunodiagnostic testing.

FIDIS™ System comprised of FIDIS flow cytometer, XYP platform for automatic sampling into the analyser, the analyzer itself, a SD pump, some assay products and a MLX-BOOSTER software.

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Image /page/2/Picture/0 description: The image shows a logo for "biomedical diagnostics". The logo consists of the letters "bmd" in a stylized font, with a horizontal line underneath. There are some black dots under the letters. The words "biomedical diagnostics" are written in a smaller font below the line.

The FIDIS™ CONNECTIVE 10 kit resembles traditional EIA, but allows simultaneous detection and identification of several antibodies in a single well.

- 1. Diluted patient sera and multiplexed bead suspension are thoroughly mixed in the 96 well microtiter plate. Antigen specific antibodies in the patient sera, if present, bind to the immobilised antigen on one or more of the bead sets. Any unbound material is removed by performing a wash step.
- 2. Phycoerythrin-conjugated goat anti-human IgG is added to the plate and a further incubation performed. The conjugated anti-human igG binds to the antigen specific antibodies immobilised on the microsphere surface to form an antigen/antibody complex.
- 3. The bead suspension is then analysed by the FIDIS™ Instrument and reactions are directly calculated in biological units using specific data software (MLX-BOOSTER).

The FIDIS™ Instrument is able to distinguish the specific color-code of each microsphere types and it could associate the microsphere type with the individual tested antigen.

The FIDIS™ Instrument can quantify the fluorescence of the antibody captured by each microsphere. Measurement of the fluorescent signal from the final reaction complex allows the quantification of the presence or absence of autoantibodies.

It's a simple (just two steps), quick (2 x 30 minutes for the two incubations) and multiple parameter test (10 specific antibodies per patient sample).

# 7. Testing

The comparability of predicate devices and new devices is supported by a data set including:

- results obtained within a comparison study analysing positive, equivocal and । negative sera
- results obtained for samples from apparently healthy subject (normal population) -
- results obtained for samples from samples with potential biological cross reactivity

## 8. Conclusions

In conclusion, all available data support that the new devices, FIDIS™ CONNECTIVE 10 kit is substantially equivalent to the predicate devices.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Image /page/3/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES (USA)" is arranged in a circular fashion around the bird-like figure.

Re:

MAR 1 3 2006

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Ms. Christelle Courivaud Regulatory Manager Biomedical Diagnostics Actipole 25 4-6 BLD De Beaubourg Marne La Vallee Cedex 2 France 77435

> k053653 Trade/Device Name: FIDIS™ Connective 10 Regulation Number: 21 CFR § 866.5100 Regulation Name: Antinuclear antibody immunological test system Regulatory Class: II Product Code: LLL, LKJ, LKJ, LKO, LKP, LSW, LJM, MQA Dated: February 17, 2006 Received: February 28, 2006

Dear Ms. Courivaud:

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). This letter will allow you to begin marketing your device as described in your Section 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.

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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 [phone]. 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html

Sincerely yours,

lobatz Beckerh

Robert L. Becker, Jr., MD, PK. Director Division of Immunology and Hematology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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Image /page/5/Picture/0 description: The image shows a logo with the text "amg" in a stylized font. The letters are large and bold, with rounded shapes. Below the letters, there is a horizontal line, and below the line is the text "biomedical diagnostics" in a smaller, sans-serif font. The logo appears to be for a company in the biomedical diagnostics field.

510(k) Number: K053653

Device Name:

#### FIDISTM CONNECTIVE 10

## Indications For Use:

The FIDIS™ CONNECTIVE 10* kit is a semi-quantitative homogeneous fluorescent based microparticles immunoassay using flow cytometry readings. It is designed for the simultaneous detection of autoantibody specificities: double stranded DNA (dsDNA), SSA (60 kDA and 52 kDA), SSB, Sm. Sm/RNP, Scl-70, Jo-1 ribosome and centromere in human serum. (* Antibodies to dsDNA, SSA, SSB, Sm, Sm/RNP, Scl-70, Jo-1, ribosome and centromere can be reported using this assay).

## Clinical utility:

The test system is used to screen serum samples and detect the presence of antinuclear antibodies associated with connective diseases systemic lupus erythematosus (SLE), Sjogren's syndrome, mixed connective tissue disease (MCTD), scleroderma, dermatomyositis, and CREST syndrome, in conjunction with clinical findings and other laboratory tests.

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OR

Division Sign-Of

Concurrence of CDRH, Office of Device Evaluation (ODE)

Office of In Vitro Diagnostic Dev Evaluation and Safety

510(k) k053653

Prescription Use (Per 21 CFR 801.109)

Professional Use

Over-The-Counter Use (Optional Format 1-2-96)

Registered Office : Actipole 25 4-6 bd de Beaubourg 77435 Mame La Vallée cedex 2