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.

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.
1. 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
1. 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).

AI/ML Overview

The provided document is a 510(k) summary for the FIDIS™ dsDNA kit, a semi-quantitative immunoassay for detecting antibodies directed against double-stranded DNA, used as an aid in the diagnosis of Systemic Lupus Erythematosus (SLE). This summary focuses on establishing substantial equivalence to a predicate device rather than detailing specific acceptance criteria and a study proving those criteria are met for a novel device. Therefore, much of the requested information, particularly regarding specific numerical acceptance criteria, detailed study results against those criteria, and information about expert consensus, is not explicitly present in the document.

However, based on the information provided, here's what can be extracted:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly define numerical "acceptance criteria" for performance metrics like sensitivity, specificity, or accuracy in a traditional sense. Instead, it relies on demonstrating substantial equivalence to a predicate device (Varelisa dsDNA antibodies by Sweden Diagnostics, GMH). The "performance" is reported in terms of comparability with this predicate device.

Performance Characteristic	Acceptance Criteria (Implied by Substantial Equivalence)	Reported Device Performance (Summary)
Comparability with Predicate	Demonstrate comparable results to legally marketed predicate (Varelisa dsDNA antibodies) across positive, equivocal, and negative sera.	"results obtained within a comparison study analysing positive, equivocal and negative scra" and "results obtained for samples from apparently healthy subject (normal population) results obtained for samples from samples with potential hiological cross reactivity" are provided to support comparability.
Clinical Utility	Aid in the diagnosis of SLE, in conjunction with clinical findings and other laboratory tests.	Intended use explicitly states: "The presence of these antibodies can be used to aid in the diagnosis of SLE."

2. Sample Size Used for the Test Set and Data Provenance

Test Set Sample Size: The document mentions "results obtained within a comparison study analysing positive, equivocal and negative sera," and "results obtained for samples from apparently healthy subject (normal population)," and "samples with potential hiological cross reactivity." However, the exact number of samples used in these studies is not specified.
Data Provenance: Not explicitly stated. The document indicates the device manufacturer (Biomedical Diagnostics S.A.) is located in France, suggesting the studies could have been conducted there or in other European countries. It is not specified if the data is retrospective or prospective.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not provided in the document. The method for establishing "ground truth" (e.g., expert diagnosis, clinical outcomes) is also not detailed.

4. Adjudication Method for the Test Set

This information is not provided in the document.

5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study

A MRMC comparative effectiveness study is not mentioned in the document. The focus is on the device's performance as an immunoassay, not on human reader improvement with or without AI assistance.

6. Standalone Performance Study

The FIDIS™ dsDNA kit itself is the "algorithm" in this context (an immunoassay performed by an automated system). The comparability study described is essentially a standalone performance assessment against a predicate.

"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"
While not using the term "standalone study," the various testing methods described are designed to evaluate the device's performance characteristics on its own.

7. Type of Ground Truth Used

The document describes the device as a "detection test of autoantibodies directed against double stranded DNA (dsDNA)" that "can be used to aid in the diagnosis of SLE." This implies that the 'ground truth' for evaluating the test performance would likely be based on:

Clinical diagnosis of SLE: Established by clinical findings and other laboratory tests, against which the presence/absence of dsDNA antibodies would be evaluated.
Predicate device results: As the primary comparison is with the "Varelisa dsDNA antibodies" predicate, the results from this established test would serve as a comparative standard.
The exact methodology for establishing the ground truth is not explicitly detailed (e.g., whether it relied on specific clinical criteria for SLE diagnosis, or primarily on concordance with the predicate).

8. Sample Size for the Training Set

This information is not provided. As a diagnostic kit, the concept of a "training set" in the context of machine learning algorithms may not directly apply. If assay parameters were optimized, the details of that process (including sample sizes) are not given.

9. How the Ground Truth for the Training Set was Established

This information is not provided.

Summary

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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 autoantibodiesdirected 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

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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.
1. 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
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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

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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.

1. 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

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.

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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 (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

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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:

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.

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

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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

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).