(77 days)
Not Found
No
The description details a standard immunoassay using flow cytometry and software for data calculation, without mentioning AI or ML algorithms for analysis or interpretation.
No.
This device is an in-vitro diagnostic (IVD) test kit used for the detection of antibodies to aid in the diagnosis of systemic lupus erythematosus (SLE). It does not directly treat or cure a disease or condition.
Yes
The device aids in the diagnosis of systemic lupus erythematosus (SLE) by detecting specific antibodies, thus providing information used for diagnostic purposes.
No
The device description clearly states that the FIDIS™ System is a fully integrated and automated system comprised of hardware components (flow cytometer, XYP platform, SD pump, analyzer) and assay products, in addition to the software. The software (MLX-BOOSTER) is used for data calculation and analysis, but it is part of a larger hardware and reagent system.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it is "designed for the detection of antibodies directed against double stranded DNA (dsDNA)" and is used on "serum samples as an aid in the diagnostic of systemic lupus erythematosus (SLE)". This clearly indicates it is intended for use in vitro (outside the body) to examine specimens from the human body for diagnostic purposes.
- Device Description: The description details a kit containing reagents (microspheres, antibodies, controls, buffer) and an instrument (flow cytometer, platform, pump, software) used to perform an immunoassay on patient serum samples. This aligns with the typical components of an IVD system.
- Clinical Utility: The stated clinical utility is "as an aid in the diagnostic of systemic lupus erythematosus (SLE)", which is a diagnostic purpose.
- Specimen Type: The test is performed on "serum samples", which are specimens taken from the human body.
- Method: The method described is a "semi-quantitative homogeneous fluorescent-based microparticles immunoassay using flow cytometry readings", which is a laboratory test method performed in vitro.
All these factors strongly indicate that the FIDIS™ dsDNA kit and the associated FIDIS™ System are intended for in vitro diagnostic use.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
LSW
Device Description
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
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. - 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
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Professional Use
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
Image /page/0/Picture/1 description: The image shows a logo with the letters 'bmd' in a stylized, lowercase font. The letters are connected at the base by a thick, black line. The letters are simple and rounded, giving the logo a modern and clean appearance.
Premarket Notification SIO(k) Summary
Assigned 510(k) Number: K060380
- 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: | HoppeRegulatory@cs.com |
2. Device Name
Trade Proprietary Name : FIDIS™ dsDNA
| Common Usual Name : | MX005 - FIDIS™ dsDNA: Detection test of autoantibodies
directed against double stranded DNA (dsDNA) |
|----------------------|--------------------------------------------------------------------------------------------------------|
| Classification Name: | Immunology and Microbiology Devices |
- Predicate Devices
| 510K Number | K950031 |
|---|---|
| Device Classification Name | Varelisa dsDNA antibodies |
| Manufacturer Name | Sweden Diagnostics, GMH |
S.A.au Capital de 2 753.46 Furna
RCS Meaux: J1 119 685 617
Bell: 339 683 6 J 2 DXPH8-AFFE No 2017 A link
linguised in Actipole 2 S
Actipole 2 S
7 3 15 Manne La Vallec codes 2
Page 1 of 3 Email Bush gifmid-net com
1
Image /page/1/Picture/0 description: The image shows a logo with the letters "bmd" in a stylized font. The letters are connected at the bottom by a horizontal line. Below the line, there is some text that is difficult to read due to the image quality. The logo appears to be for a company or organization with a name that starts with the letters "bmd".
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.
-
- 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
S A au Captal de 2 711,46 Euros
RCS Meaux: 18 337 685 612
RCS Meaux: 18 339 685 612
Nº TVA Int
Registered Office Actipok 25
44 hd dc Beaubourg 77.135 Marne 1.a Vullee cedes 2
Icl. 33 (0)1 64 62 10 12 Pax 3.3 (1) 1 64 62 09 66 Email: houd gebruit de com
2
Image /page/2/Picture/0 description: The image shows a logo with the letters 'bmd' in a stylized font. Below the letters, there is some smaller text that reads 'biomedical diagnostics'. The logo appears to be for a company in the biomedical diagnostics field.
-
- 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
- The bead suspension is then analysed by the FIDISTM Instrument and reactions are directly calculated in biological units using specific data software (MLX-BOOSTER)
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
を 2 755.46 Euros
10.139 685 612
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3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is an abstract image of an eagle.
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.
4
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 (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. 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
5
Image /page/5/Picture/0 description: The image shows a logo with the letters 'bmd' in a stylized font. Below the letters, the words 'biomedical diagnostics' are written in a smaller, sans-serif font. The logo appears to be for a company in the biomedical or diagnostic field.
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