FIDIS CONNECTIVE 8 by BIOMEDICAL DIAGNOSTICS (BMD) SA

The FIDISTN CONNECTIVE 8* kit is a semi-quantitative homogencous fluorescentbased microparticles immunoassay using flow cytometery readings. It is designed for the simultaneous detection of 8 autoantibody specificities: double stranded DNA (dsDNA), SSA 60 kDa, SSA 52 kDa, SSB, Sm, Sm/RNP, Sc170 and Jo-1 (*antibodies to dsDNA, Sm, Sm/RNP, SS-A, SS-B, Scl-70 and Jo-1 can be reported using this assay).

Clinical utility:

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 tissue disease (MCTD), scleroderma, dermatomyositis, polymyositis in conjunction with clinical findings and other laboratory tests.

Device Description

The FIDISTN CONNECTIVE 8* kit is a semi-quantitative homogencous fluorescentbased microparticles immunoassay using flow cytometery readings.

AI/ML Overview

The provided text is a 510(k) summary for the FIDIS™ Connective 8 device, which is an immunoassay for the detection of autoantibodies associated with connective tissue diseases. It does not contain a study detailing the device's performance against acceptance criteria in the way an AI/ML device submission would. This document is a regulatory clearance letter and the "Indications For Use" statement.

Therefore, I cannot extract the requested information (acceptance criteria, device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, training set details) from this document. The document describes the device, its intended use, and the FDA's determination of substantial equivalence to predicate devices, but not a detailed study report of its performance metrics.

Summary

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Biomedical Diagnostics (BMD) SA c/o Ms Christelle Courivaud Assurance Quality/Regulatory Affairs Manager Actipole 25 - 4 Bld de Beaubourg 77435 Marne-La-Vallée cedex 2 France

OCT 3 - 2005

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Re: K050286

Trade/Device Name: FIDIS™ Connective 8* Regulation Number: 21 CFR 866.5100 Regulation Name: Antinuclear antibody, antigen and control Regulatory Class: Class II Product Code: LLL, LKJ, LKJ, LKO, LKP, LSW Dated: February 4, 2005 Received: February 7, 2005

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 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.

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 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 fabeling 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 (240) 276-0484. 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/industry/support/index.html

Sincerely yours,

lobetz Beckerh

Robert L. Becker, Jr., MD, PAD 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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510(k) Number (if Known)

K050286

Device Name:

FIDISTM CONNECTIVE 8

Indications For Use:

Clinical utility:

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODDE)

Professional Use _________

Prescription Use _ X ----------------------------------------------------------------------------------------------------------------------------------------------------------------------------(Per 21 CFR 801.109)

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

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Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and

510(k) K050286

Regulation Number and Section

§ 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).