FIDIS DSDNA

K060380 · Biomedical Diagnostics (Bmd) SA · LSW · May 2, 2006 · Immunology

Device Facts

• Record ID: K060380
• Device Name: FIDIS DSDNA
• Applicant: Biomedical Diagnostics (Bmd) SA
• Product Code: LSW · Immunology
• Decision Date: May 2, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.5100
• Device Class: Class 2

Intended Use

The FIDIS™ dsDNA kit is a semi-quantitative homogeneous fluorescent-based microparticles immunoassay using flow cytometry readings. It is designed for the detection of antibodies directed against double stranded DNA. The presence of these antibodies can be used in conjunction with clinical findings to aid in the diagnosis of SLE. The FIDIS™ dsDNA kit is to be used on serum only and used on the FIDIS™ Analyzer, MLX Booster software and washer.

Device Story

FIDIS™ dsDNA is a semi-quantitative fluorescent immunoassay for detecting anti-dsDNA antibodies. Input: patient serum samples mixed with dsDNA-coupled color-coded microspheres in 96-well plates. Process: patient antibodies bind to bead-immobilized antigen; unbound material washed; phycoerythrin-conjugated anti-human IgG added to form antigen/antibody complex. Output: fluorescence intensity measured via flow cytometry. System includes FIDIS analyzer, XYP platform for automatic sampling, and MLX-BOOSTER software. Used in clinical laboratories by trained personnel. Software identifies microsphere color codes to associate with specific antigens and quantifies fluorescence to calculate biological units. Results aid clinicians in diagnosing SLE.

Clinical Evidence

No clinical prospective or retrospective studies were performed. Evidence consists of bench testing, including precision/reproducibility (within-run and between-run CVs reported), analytical specificity (cross-reactivity testing with 35 samples), and a method comparison study against the predicate device (N=400) showing 96.33% positive agreement and 95.53% negative agreement. Cut-off establishment was performed using 85 samples (50 normal, 35 with potential interference).

Technological Characteristics

Multiplex bead-based flow cytometric immunoassay. Uses color-coded microspheres coupled with recombinant dsDNA. Detection via phycoerythrin-labeled anti-human IgG conjugate. Instrumentation: Luminex 100 flow cytometer with red (classification) and green (quantification) lasers. Digital signal processing hardware and software. Serum matrix only. Prescription use.

Indications for Use

Indicated for use in serum samples to detect anti-double stranded DNA (dsDNA) antibodies to aid in the diagnosis of Systemic Lupus Erythematosus (SLE) in conjunction with clinical findings.

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)

Submission Summary (Full Text)

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Premarket Notification SIO(k) Summary

Assigned 510(k) Number: k060380

1. Submitted by :

Namic Contact Person

Address

Telephone liax: Establishment
Registration Number 3003935253

Christelle COURIVAUID Regulatory Affairs Manager Actipole 25, 4-6 Bld de Beaubourg 77435 Marne-La-Vallèe Cedex 2 FRANCE 33 (0)1 64 62 10 12 33 (0)1 64 62 09 66

Biomedical Diagnostics S A (bmd)

US Agent correspondent

| Hoppe Regulatory Consultants | |
|------------------------------|------------------------|
| Ms P. Ann HOPPE | |
| 2335 Massey Lane | |
| Decatur GA 30033 USA | |
| Phone: | 404 248 0002 |
| E-mail: | [e-mail] |

# 2. Device Name

Trade Proprietary Name : FIDIS™ dsDNA

| Common Usual Name : | MX005 - FIDIS™ dsDNA: Detection test of autoantibodies<br>directed against double stranded DNA (dsDNA) |
|----------------------|--------------------------------------------------------------------------------------------------------|
| Classification Name: | Immunology and Microbiology Devices |

3. Predicate Devices

| 510K Number | K950031 |
|----------------------------|---------------------------|
| Device Classification Name | Varelisa dsDNA antibodies |
| Manufacturer Name | Sweden Diagnostics, GMH |

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Page 1 of 3 Email Bush gifmid-net com

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#### 4. Intended use of the device

The FIDIS™ dsDNA kit is a semi-quamitative homogeneous fluorescent-based description for them monoussays using flow cytometry readings In is designed for the detection of antibodies directed against double stranded DNA (dsDNA).

## The presence of these antibodies can be used to aid in the diagnosis of SLE.

#### 5. Description of the Device

The assay kits consist of

- a vial of color-coded microspheres coupled with dsDNA
- a ready to use anti-human IgG coupled to phycoerythrin.
- a ready to use calibrator littered for the specificity.
- a positive control lgG 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 invmunodiagnostic lesting

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

The IIIDIS™ dsDNA kit resembles traditional EIA and allows the detection and identification of antibodies against dsDNA

- i . Diluted patient sera and microsphere suspension are thoroughly mixed in the 96 well microtiter plate. dsDNA specific antibodies in the patient sera, if present, bind to the immobilised untigen on the beads. Any unbound material is removed by performing a wash step.
- 2. Phycoerythrin-conjugated goal anti-human IgG is added to the plate and a further antibedies, immentiliand antibodies immobilised on the microsphere surface to form an antigen/antibody complex

#### Page 2 of 3

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- 3. The bead suspension is then analysed by the FIDISTM Instrument and reactions are directly calculated in biological units using specific data software (MLX-BOOSTER)
The FIDIS™ Instrument is able to distinct the specific code-colored of the microsphere and it could associated the microsphere type with the individual tested antigen. The FIDIS™ Instrument could quantify the finorescente of the antibody captured by
each microsphere. Measurent of the finorescence of the antibody captured by
allows the overl allows the quantification of the presence or absence of autoantibudies m

It's a simple (just two steps) and quick (2 x 30 minutes for the two incubations).

### 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 scra .
- results obtained for samples from apparently healthy subject (normal population) results obtained for samples from samples with potential hiological cross reactivity

### 8. Conclusions

for conclusion, all available data support that the new devices, FIDIS™ dsDNA kit is substantially equivalent to the predicate devices.

#### Page 3 of 3

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# DEPARTMENT OF HEALTH & HUMAN SERVICES

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### Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Biomedical Diagnostics (BMD) SA c/o Ms. Christelle Courivaud Regulatory Manager Actipole 25 4-6 Bld de Beaubourg 77435 Marne La Vallée cedex2 France

Re: k060380

Trade/Device Name: FIDISTM dsDNA Regulation Number: 21 CFR 866.5100 Regulation Name: Antinuclear antibody immunological test system Regulatory Class: Class II Product Code: LSW Dated: January 30, 2006 Received: February 22, 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.

MAY

2 2006

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 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance 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,

Robert H. Borke

Robert L. Becker, Jr., MA., Ph.D. 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 (if Known) k060380

Device Name:

# FIDISTN dsDNA

Indications For Use:

The FIDIS™ dsDNA kit is a semi-quantitative homogeneous fluorescent-based microparticles immunoassay using flow cytometry readings. It is designed for the detection of antibodies directed against double stranded DNA (dsDNA)

Clincal unlity:

The test system is used on serum samples as an aid in the diagnostic of systemic lupus erythematosus (SLE), in conjunction with clinical findings and other laboratory tests.

The FIDIS™ dsDNA kit is to be used on FIDIS™ Analyser, software and washer.

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Concurrence of CDRH, Office of Device Evaluation (ODI)

Professional Use _____________________________________________________________________________________________________________________________________________________________

Preseription Use xl (Per 21 CFR 801 109)

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

Mana CKar

Office of In Vitro Diagnostic
Device Evaluation and Safety

510(k) K060580