(127 days)
The FIDIS™ VASCULITIS* kit is a semi-quantitative homogeneous fluorescent-based microparticles immunoassay using flow cytometry readings. The test system is used to detect in patient serum samples the presence of anti-neutrophil cytoplasm antibodies (ANCA) directed against Myeloperoxidase (MPO) and Serine Proteinase 3 (PR3) ; and anti-glomerular basement membrane (GBM) antibodies.
The results of the FIDIS™ VASCULITIS* test are to be used in conjunction with the clinical findings and the other laboratory tests to aid in the diagnosis of various primary systemic small vessel vasculitis.
Clinical utility:
The presence of anti-MPO and anti-PR3 antibodies associated primary systemic small vessel vasculitis: Wegener's granulomatosis, Churg Strauss syndromes, microscopic periarteritis and idiopatic crescentic glomerulonephritis; and the presence of anti-GBM antibodies is associated with Goodpasture's syndrome.
FIDIS™ VASCULITIS* kit is used on the FIDIS Analyser, MLX-BOOSTER Software and Washer.
FIDIS™ VASCULITIS* kit could be used with CARIS™ system (diluting and dispensing device).
This test is for in vitro diagnostic use.
- Detection of the serologic markers for primary systemic small vessel vasculitis (ANCA) and for Goodpasture syndrome (GBM)
The FIDIS™ VASCULITIS* kit is a semi-quantitative homogeneous fluorescent-based microparticles immunoassay using flow cytometry readings.
The provided document is a 510(k) clearance letter for the FIDIS™ VASCULITIS* device and its "Indications For Use" statement. It does not contain information about acceptance criteria, detailed study results, sample sizes for training or test sets, expert qualifications, or adjudication methods for ground truth establishment.
Based on the nature of the document as an FDA 510(k) clearance, it primarily focuses on the device's substantial equivalence to a legally marketed predicate device rather than comprehensive performance study details. The information required in the prompt (acceptance criteria, study details, sample sizes, expert qualifications, etc.) is typically found in the 510(k) summary or the full 510(k) submission, not in the clearance letter itself.
Therefore, I cannot provide the requested information from the given text.
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Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
MAR 2 2006
Biomedical Diagnostics (BMD) SA c/o Mrs. Christelle Courivaud Regulatory Manager Actipole 25, 4 Bld de Beaubourg 77435 Marne La Vallée Cedex 2 France
Re: K053012 Trade/Device Name: FIDISTM VASCULIS* Regulation Number: 21 CFR 866.5660 Regulation Name: Multiple autoantibodies, immunological test system Regulatory Class: Class II Product Code: MOB, MVJ Dated: October 21, 2005 Received: October 26, 2005
Dear Mrs. 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.
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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 (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,
Robert H Bestarf
Robert L. Becker, Jr., M.D., Ph.P 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):
Device Name:
FIDIS™ VASCULITIS*
Indications For Use:
The FIDIS™ VASCULITIS* kit is a semi-quantitative homogeneous fluorescent-based microparticles immunoassay using flow cytometry readings. The test system is used to detect in patient serum samples the presence of anti-neutrophil cytoplasm antibodies (ANCA) directed against Myeloperoxidase (MPO) and Serine Proteinase 3 (PR3) ; and anti-glomerular basement membrane (GBM) antibodies.
The results of the FIDIS™ VASCULITIS* test are to be used in conjunction with the clinical findings and the other laboratory tests to aid in the diagnosis of various primary systemic small vessel vasculitis.
Clinical utility:
The presence of anti-MPO and anti-PR3 antibodies associated primary systemic small vessel vasculitis: Wegener's granulomatosis, Churg Strauss syndromes, microscopic periarteritis and idiopatic crescentic glomerulonephritis; and the presence of anti-GBM antibodies is associated with Goodpasture's syndrome.
FIDIS™ VASCULITIS* kit is used on the FIDIS Analyser, MLX-BOOSTER Software and Washer.
FIDIS™ VASCULITIS* kit could be used with CARIS™ system (diluting and dispensing device).
This test is for in vitro diagnostic use.
- Detection of the serologic markers for primary systemic small vessel vasculitis (ANCA) and for Goodpasture syndrome (GBM)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Mana McChan
(Division Sign Division of Clinical Laboratory Devices
Professional Use
Prescription Use (Per 21 CFR 801.109) OR
Over-The-Counter Use (Optional Format 1-2-96)
S.A au Capital de 2 755.46 Euros RCS Meaux: B 339 685 612 Siret: 339 685 612 00048-APE: 514N N° TVA Intracommunautaire: FR 68 339 685 612
Adresse Postale: Actipole 25 4 bd de Beaubourg 77435 Marne La Vallée cedex 2
Tél: 33 (0)1 64 62 10 12 Fax : 33 (0)1 64 62 09 66 Email: bmd(@bmd-net.com Internet : www.bmd-net.com
§ 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).