Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a standard immunoassay using flow cytometry and software for data processing and calibration. There is no mention of AI or ML algorithms for analysis or interpretation.

Therapeutic

No
Explanation: The device is an in vitro diagnostic (IVD) device used to detect autoantibodies to aid in the diagnosis of connective diseases, not to treat them.

Diagnostic

Yes

The device aids in the diagnosis of connective diseases by detecting autoantibody specificities, and its results are to be used in conjunction with clinical findings and other laboratory tests for diagnostic purposes.

SaMD (Software as a Medical Device)

No

The device description clearly outlines a physical kit containing microspheres, a microplate, and reagents, which are used in conjunction with a flow cytometer instrument. While software (MLX-BOOSTER™ Software) is mentioned as part of the system, the core of the device is a physical in vitro diagnostic assay kit.

IVD (In Vitro Diagnostic)

Yes, this device is an IVD (In Vitro Diagnostic).

Here's why:

Explicit Statement: The "Intended Use / Indications for Use" section explicitly states: "This kit is for In vitro diagnostic use."
Intended Use: The device is intended to "simultaneously detect the presence of 10 autoantibody specificities" in serum samples to "aid in the diagnosis of connective diseases." This is a classic definition of an in vitro diagnostic test.
Sample Type: It uses "serum only," which is a biological sample taken from the human body.
Testing Method: It performs a "semi-quantitative homogeneous fluorescent-based microparticles immunoassay using flow cytometry," which is a laboratory-based testing method.
Clinical Utility: The results are intended to be used "in conjunction with the clinical findings and the other laboratory tests to aid in the diagnosis of connective diseases," indicating a clinical diagnostic purpose.
Device Description: The description details a laboratory test kit and its components used for analyzing biological samples.
Performance Studies: The document includes performance studies (precision and comparison studies) which are typical for demonstrating the analytical and clinical performance of an IVD.
Intended User: The "Intended User / Care Setting" is listed as "In vitro Diagnostic Use," further confirming its classification.

All these points strongly indicate that the FIDIS™ CONNECTIVE 10 kit is an In Vitro Diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The FIDIS™ CONNECTIVE 10* kit is a semi-quantitative homogeneous fluorescent-based microparticles immunoassay using flow cytometry. The test system is used to simultaneously detect the presence of 10 autoantibody specificities: double stranded DNA (dsDNA), SS-A (60kDa and TRIM 21 (SS-A 52kDa)), SS-B, Sm, Sm/RNP, Scl-70, Jo-1, ribosomes and centromere (CENP-B).

(*Antibodies to dsDNA, Sm, Sm/RNP, SS-A, SS-B, Scl-70, Jo-1, ribosomes and CENP-B can be reported using this assay).

Product codes

LLL, LKJ, LKO, LKP, LSW, LJM, MQA

Device Description

FIDIS™ CONNECTIVE 10 kit is a multiplex flow immunoassay, which allows simultaneous identification and detection of several antibodies.

FIDIS™ CONNECTIVE 10 is based on the use of distinct uniform size color-coded microsphere sets and a benchtop flow cytometer interfaced to digital signal processing hardware and software. A red diode laser beam in the flow cytometer recognizes each set of microspheres on the basis of its unique fluorescence intensity (red and infrared) thus identifying which parameter is being tested. At the same time, a green laser beam illuminates the external second molecule fluorescence to quantify the reaction related to the specific antigen.

Ten different fluorescently "colored" sets of microspheres are coated with antigens associated with various connective diseases (dsDNA, SS-A (60kDA and TRIM 21 (SS-A 52kDa}}, SS-B, Sm, Sm/RNP, Scl-70, Jo-1, ribosomes and centromere). An additional microsphere (Internal Bead standard) set is coated with anti-IgG to ensure that false negative results due to operational error are detected.

The eleven different sets of microspheres are mixed together. The mixture is lyophilized and constitutes the final microspheres reagent.

The test is performed using a 96 wells microplate with a filtering membrane at the bottom of the wells.
In the first step, the sample is distributed in each well containing the reconstituted microspheres mixture, allowing any anti-dsDNA; anti-SS-A (60kDa and TRIM 21 (SS-A 52kDa)), anti-SS-B, anti-Sm, anti-Sm/RNP, anti-Scl-70, anti-Io-1, anti-ribosomes and anti-centromere antibodies present to bind to the immobilized antigens on the microspheres, as well as free IgG to bind to the anti-IgG microsphere.

After incubation, a wash step using a filtration process removes the unbound antibodies.

A phycoerythrin anti-human IgG conjugate is then added that binds to the previously bound antibodies.

A final wash step stops the reaction and eliminates the unbound conjugate.

The reaction is then measured directly by the flow cytometer, which distinguishes each set of microspheres by its fluorescence color while simultaneously measuring the average fluorescence emitted by the conjugate. ·

A calibration system allows the determination of the titer (AU/mL) of each sample by interpolation for each antigenic specificity.

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

Not Found

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)

7.1. Precision study - Using Manual Pipetting

Precision of the assay was assessed in using 6 samples for each of 7 analytes (dsDNA, SS-A 60kDa & TRIM 21 (SS-A 52 kDa), SS-B, Sm, Sm/RNP, Jo-1 and CENP-B) and only in using 5 samples for Scl-70 and Ribosomes. Precision was determined by calculating the within-run (intra-assay) and the between-run (inter-assay).
For within-run: 10 tests in a same run.
For between-run: 5 runs, 1 test per run.

7.2. Comparison study with predicate - Using Manual Pipetting

bmd has compared the results obtained with modified FIDIS™ CONNECTIVE 10 versus the results obtained with predicate FIDISTM CONNECTIVE 10 K071210.
The study was performed on 80 samples characterized with the predicate test and the result repartition is described below:

77 samples were positive for one or more parameters (see table 3)
3 negative samples.
Result: All of results show that FIDISTM CONNECTIVE 10 considered substantially equivalent to the predicate K071210IS™ CONNECTIVE 10.

7.3.Performance data for modified FIDIS™ CONNECTIVE 10 with CARIS™ (diluting/ dispensing Device)

a. Precision study

Precision of the assay was assessed in using 6 samples for each of 7 analytes (dsDNA, SS-A 60kDa & TRIM 21 (SS-A 52 kDa), SS-B, Sm, Sm/RNP, Jo-1 and CENP-B) and only in using 5 samples for Scl-70 and Ribosomes. Precision was determined by calculating the within-run (intra-assay) and the between-run (interassay).
For within-run: 10 tests in a same run.
For between-run: 5 runs, 1 test per run.

b. Comparison studies (manual versus automated assay preparation steps)

bmd has compared the results obtained with modified FIDISTM CONNECTIVE 10 for manual or automated (with CARIS™).assay preparation steps.
The study was performed on 80 samples characterized with the predicate test and the result repartition is described below:

77 samples were positive for one or more parameters . (see table 10)
3 negative samples. .
Result: All of previous evaluations results indicate that manual and automated (with CARISTM) assay preparation steps are considered substantially equivalents.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Comparison Study with Predicate (Manual Pipetting) - Equivocal results considered negative:

dsDNA:

Positive percent agreement: 100% (16/16)
Negative percent agreement: 98.4% (63/64)
Overall agreement: 98.8% (79/80)

SS-A 60kDa:

Positive percent agreement: 100% (25/25)
Negative percent agreement: 98.2% (54/55)
Overall agreement: 98.8% (79/80)

TRIM 21 (SS-A 52kDa):

Positive percent agreement: 95.8% (23/24)
Negative percent agreement: 100% (56/56)
Overall agreement: 98.8% (79/80)

Sm:

Positive percent agreement: 100% (17/17)
Negative percent agreement: 100% (63/63)
Overall agreement: 100% (80/80)

SS-B:

Positive percent agreement: 100% (14/14)
Negative percent agreement: 98.5% (65/66)
Overall agreement: 98.8% (79/80)

Sm/RNP:

Positive percent agreement: 100% (19/19)
Negative percent agreement: 98.4% (60/61)
Overall agreement: 98.8% (79/80)

Scl-70:

Positive percent agreement: 100% (15/15)
Negative percent agreement: 96.9% (63/65)
Overall agreement: 97.5% (78/80)

CENP-B:

Positive percent agreement: 100% (7/7)
Negative percent agreement: 98.6% (72/73)
Overall agreement: 98.8% (79/80)

Jo-1:

Positive percent agreement: 100% (10/10)
Negative percent agreement: 100% (70/70)
Overall agreement: 100% (80/80)

Ribosomes:

Positive percent agreement: 100% (6/6)
Negative percent agreement: 100% (74/74)
Overall agreement: 100% (80/80)

Comparison Study with Predicate (Manual Pipetting) - Equivocal results considered positive:

dsDNA:

Positive percent agreement: 100% (17/17)
Negative percent agreement: 100% (63/63)
Overall agreement: 100% (80/80)

SS-A 60kDa:

Positive percent agreement: 100% (29/29)
Negative percent agreement: 100% (51/51)
Overall agreement: 100% (80/80)

TRIM 21 (SS-A 52kDa):

Positive percent agreement: 100% (25/25)
Negative percent agreement: 98.2% (54/55)
Overall agreement: 98.8% (79/80)

Sm:

Positive percent agreement: 100% (18/18)
Negative percent agreement: 100% (62/62)
Overall agreement: 100% (80/80)

SS-B:

Positive percent agreement: 100% (19/19)
Negative percent agreement: 100% (61/61)
Overall agreement: 100% (80/80)

Sm/RNP:

Positive percent agreement: 95.2% (20/21)
Negative percent agreement: 98.3% (58/59)
Overall agreement: 97.5% (78/80)

Scl-70:

Positive percent agreement: 100% (17/17)
Negative percent agreement: 100% (63/63)
Overall agreement: 100% (80/80)

CENP-B:

Positive percent agreement: 100% (8/8)
Negative percent agreement: 100% (72/72)
Overall agreement: 100% (80/80)

Jo-1:

Positive percent agreement: 100% (12/12)
Negative percent agreement: 100% (68/68)
Overall agreement: 100% (80/80)

Ribosomes:

Positive percent agreement: 100% (7/7)
Negative percent agreement: 100% (73/73)
Overall agreement: 100% (80/80)

Performance Data with CARIS™ (Diluting/Dispensing Device) - Equivocal results considered negative:

dsDNA:

Positive percent agreement: 100% (16/16)
Negative percent agreement: 98.4% (63/64)
Overall agreement: 98.8% (79/80)

TRIM 21 (SS-A 52kDa):

Positive percent agreement: 100% (22/22)
Negative percent agreement: 98.3% (57/58)
Overall agreement: 98.8% (79/80)

Sm:

Positive percent agreement: 100% (16/16)
Negative percent agreement: 98.4% (63/64)
Overall agreement: 98.8% (79/80)

SS-A 60kDa:

Positive percent agreement: 100% (26/26)
Negative percent agreement: 98.1% (53/54)
Overall agreement: 98.8% (79/80)

SS-B:

Positive percent agreement: 100% (15/15)
Negative percent agreement: 100% (65/65)
Overall agreement: 100% (80/80)

Sm/RNP:

Positive percent agreement: 100% (20/20)
Negative percent agreement: 100% (60/60)
Overall agreement: 100% (80/80)

Scl-70:

Positive percent agreement: 100% (15/15)
Negative percent agreement: 96.9% (63/65)
Overall agreement: 97.5% (78/80)

CENP-B:

Positive percent agreement: 100% (8/8)
Negative percent agreement: 100% (72/72)
Overall agreement: 100% (80/80)

Jo-1:

Positive percent agreement: 100% (10/10)
Negative percent agreement: 100% (70/70)
Overall agreement: 100% (80/80)

Ribosomes:

Positive percent agreement: 100% (6/6)
Negative percent agreement: 100% (74/74)
Overall agreement: 100% (80/80)

Performance Data with CARIS™ (Diluting/Dispensing Device) - Equivocal results considered positive:

dsDNA:

Positive percent agreement: 100% (17/17)
Negative percent agreement: 100% (63/63)
Overall agreement: 100% (80/80)

TRIM 21 (SS-A 52kDa):

Positive percent agreement: 100% (26/26)
Negative percent agreement: 100% (54/54)
Overall agreement: 100% (80/80)

Sm:

Positive percent agreement: 100% (17/17)
Negative percent agreement: 100% (63/63)
Overall agreement: 100% (80/80)

SS-A 60kDa:

Positive percent agreement: 100% (29/29)
Negative percent agreement: 100% (51/51)
Overall agreement: 100% (80/80)

SS-B:

Positive percent agreement: 100% (17/17)
Negative percent agreement: 96.8% (61/63)
Overall agreement: 97.5% (78/80)

Sm/RNP:

Positive percent agreement: 95.2% (20/21)
Negative percent agreement: 100% (59/59)
Overall agreement: 98.8% (79/80)

Scl-70:

Positive percent agreement: 100% (17/17)
Negative percent agreement: 100% (63/63)
Overall agreement: 100% (80/80)

CENP-B:

Positive percent agreement: 100% (8/8)
Negative percent agreement: 98.6% (71/72)
Overall agreement: 98.8% (79/80)

Jo-1:

Positive percent agreement: 100% (12/12)
Negative percent agreement: 100% (68/68)
Overall agreement: 100% (80/80)

Ribosomes:

Positive percent agreement: 100% (7/7)
Negative percent agreement: 100% (73/73)
Overall agreement: 100% (80/80)

Predicate Device(s)

K071210

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

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).

Summary

0

K102607

DEC - 3 2010

Image /page/0/Picture/2 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 letters "bmd" are connected by a horizontal line, and there are small, rounded shapes underneath each letter.

Premarket Notification 510(k) Summary FIDIS™ CONNECTIVE 10 Assay kit and Multiparameters quality control

3003935253

Assigned 510(k) Number:

Submitted by : Name:

Contact Person:

Address:

Telephone: Fax: Establishment Registration Number: Biomedical Diagnostics S.A (bmd) Christelle COURIVAUD Regulatory Affairs Manager Actipole 25, 4-6 Bld de Beaubourg 77435 Marne-La-Vallée Cedex 2 FRANCE 33 (0)1 64 62 10 12 33 (0)1 64 62 09 66

US Agent correspondent:

P. Ann Hoppe, President Hoppe Regulatory Consultants LLC 103 South Cherry Street Falls Church VA 22046 703 532 1145 Office FAX 703 592 9024 E-mail: HoppeRegulatory(@cs.com

2) Device Name

Trade/Proprietary Name :

FIDISTM CONNECTIVE 10 Assay kit

Classification Names:

Common/Usual Name :

Antinuclear Antibody Immunological Test System

MX006 - MX506 - FIDIS™ CONNECTIVE 10: Detection test for autoantibodies directed against dsDNA, .SS-A (60kDa and TRIM 21 (SS-A 52kDa), SS-B, Sm, Sm/RNP, Scl-70, Jo-1, ribosomes and centromere (CENP-B).

S.A au Capital de 2 755.46 Euros RCS Meaux: B 339 685 612 Siret: 339 685 612 00048-APE: 514N Nº TVA Intracommunautaire: FR 68 339 685 612

Registered Office .: Actipole 25 4-6 bd de Beaubourg 77435 Mame La Vallée cedex 2

Tel: 33 (0)1 64 62 10 12 Fax : 33 (0)1 64 62 09 66 Email: bindi@bmd-net.com Internet : www.bmd-net.com

1

Image /page/1/Picture/0 description: The image shows a logo for "biomedical diagnostics". The logo consists of the letters "bmd" in a stylized font, with a line underneath. Below the line, the words "biomedical diagnostics" are written in a smaller, sans-serif font. The letters "bmd" are connected and have a rounded appearance.

Trade/Proprietary Name :

Classification Name:

Instrumentation for Chemical Multiplex Systems

Trade/Proprietary Name :

Classification Name:

CARISTM System

FIDISTM Analyzer

Device, Microtiter diluting/Dispensing

3). Legally marketed equivalent device

510K Number	Device Classification Name	Manufacturer Name
K071210	FIDISTM CONNECTIVE 10	Biomedical Diagnostics
S.A.(bmd)

4) Device description

FIDIS™ CONNECTIVE 10 kit is a multiplex flow immunoassay, which allows simultaneous identification and detection of several antibodies.

FIDIS™ CONNECTIVE 10 is based on the use of distinct uniform size color-coded microsphere sets and a benchtop flow cytometer interfaced to digital signal processing hardware and software. A red diode laser beam in the flow cytometer recognizes each set of microspheres on the basis of its unique fluorescence intensity (red and infrared) thus identifying which parameter is being tested. At the same time, a green laser beam illuminates the external second molecule fluorescence to quantify the reaction related to the specific antigen.

Ten different fluorescently "colored" sets of microspheres are coated with antigens associated with various connective diseases (dsDNA, SS-A (60kDA and TRIM 21 (SS-A 52kDa}}, SS-B, Sm, Sm/RNP, Scl-70, Jo-1, ribosomes and centromere). An additional microsphere (Internal Bead standard) set is coated with anti-IgG to ensure that false negative results due to operational error are detected.

The eleven different sets of microspheres are mixed together. The mixture is lyophilized and constitutes the final microspheres reagent.

The test is performed using a 96 wells microplate with a filtering membrane at the bottom of the wells.

S.A au Capital de 2 755.46 Euros RCS Meaux: B 339 685 612 Siret: 339 685 612 00048-APE: 514N Nº TVA Intracommunautaire: FR 68 339 685 612

Registered Office : . Actipole 25 4-6 bd de Beaubourg 77435 Marne La Vallée cedex 2

Tel: 33 (0)1 64 62 10 12 Fax : 33 (0)1 64 62 09 66 Email: bind(@bmd-net.com Internet : www.bmd-net.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 a horizontal line with some curved shapes underneath. Underneath the line, the words 'biomedical diagnostics' are written in a smaller, sans-serif font.

In the first step, the sample is distributed in each well containing the reconstituted microspheres mixture, allowing any anti-dsDNA; anti-SS-A (60kDa and TRIM 21 (SS-A 52kDa)), anti-SS-B, anti-Sm, anti-Sm/RNP, anti-Scl-70, anti-Io-1, anti-ribosomes and anti-centromere antibodies present to bind to the immobilized antigens on the microspheres, as well as free IgG to bind to the anti-IgG microsphere.

After incubation, a wash step using a filtration process removes the unbound antibodies.

<> A phycoerythrin anti-human IgG conjugate is then added that binds to the previously bound antibodies.

A final wash step stops the reaction and eliminates the unbound conjugate.

<> The reaction is then measured directly by the flow cytometer, which distinguishes each set of microspheres by its fluorescence color while simultaneously measuring the average fluorescence emitted by the conjugate. ·

<> A calibration system allows the determination of the titer (AU/mL) of each sample by interpolation for each antigenic specificity.

Kit components

		MX006	MX506
96 wells microplate with filtering membrane and lid.	MP	1 plate	5 plates
Vial (A) of color-coded microsphere set of 10 sensitized by dsDNA, SS-A 60 kDa, TRIM 21 (SS-A 52
kDa), SS-B, Sm, Sm/RNP, Scl-70, Jo-1, ribosomes and CENP-B antigen(s).
Lyophilized (to be reconstituted with the buffer named D)	MICROSPHERES	qs 6mL	5 x qs 6mL
Vial (B1) of sample dilution buffer (white vial)
Ready to use	DIL SPE	2 × 115mL	10 x 115mL
Vial of calibrator*
Ready to use
Each titer is printed on the vial label	CAL	1 x 1.5mL	5 x 1.5mL
Vial of positive control concentrated. This control has a standard reactivity, which provides evidence
of the proper reagents activity and proper assay performance.
To be diluted
Expected values are printed on the vial label.	CONTROL +	1 × 250 µL	5 x 250µL
Vial of negative control concentrate
To be diluted	CONTROL -	1 x 250µL	5 x 250µL
Vial of anti-human IgG coupled to phycoerythrin
Ready to use	CONJ IgG	1 x 12mL	5 x 12mL
Vial (C1) of washing buffer (black vial)
Ready to use	BUF WASH	1 × 100mL	5 x 100mL
Vial (D) of reconstitution buffer for the microsphere set
Ready to use	BUF MICROSPHERES	1 x 6mL	5 x 6mL

S.A au Capital de 2 755.46 Euros RCS Meaux: B 339 685 612 Siret: 339 685 612 00048-APE: 514N Nº TVA Intracommunautaire: FR 68 339 685 612

Registered Office : Activole 25 4-6 bd de Beaubourg 77435 Marne La Vallée cedex 2

Tel: 33 (0) 1 64 62 10 12 Fax : 33 (0)1 64 62 09 66 Email; bind@bmd-net.com Internet : www.bmd-net.com

3

Image /page/3/Picture/0 description: The image shows a logo for "bmd biomedical diagnostics". The letters "bmd" are in a stylized, sans-serif font, with each letter connected to a horizontal line. Below the line, the words "biomedical diagnostics" are written in a smaller, sans-serif font. There are some small, rounded shapes between the letters and the line.

Intended use

FIDISTM CONNECTIVE 10 Assay kit

The FIDIS™ CONNECTIVE 10* kit is a semi-quantitative homogeneous fluorescentbased microparticles immunoassay using flow cytometry. The test system is used to simultaneously detect the presence of 10 autoantibody specificities: double stranded DNA (dsDNA), SS-A (60kDa and TRIM 21 (SS-A 52kDa)), SS-B, Sm, Sm/RNP, Scl-70, Jo-1, ribosomes and centromere (CENP-B).

(*Antibodies to dsDNA, Sm, Sm/RNP, SS-A, SS-B, Scl-70, Jo-1, ribosomes and CENP-B can be reported using this assay).

Clinical utility:

The results of the FIDIS™ CONNECTIVE 10 are to be used in conjunction with the clinical findings and the other laboratory tests to aid in the diagnosis of connective diseases (systemic lupus erythematosus (SLE), Sjogren's syndrome, mixed connective tissue disease (MCTD), scleroderma, dermatomyositis and CREST syndrome).

FIDIS™ CONNECTIVE 10 kit uses serum only, and is to be run on the FIDIS™ Instrument and MLX-BOOSTER™ Software.

FIDIS™ CONNECTIVE 10 kit may be used with the CARIS™ system (diluting and dispensing device).

This kit is for In vitro diagnostic use.

S.A au Capital de 2 755.46 Euros RCS Meaux: B 339 685 612 Siret: 339 685 612 00048-APE: 514N Nº TVA Intracommunautaire: FR 68 339 685 612

Registered Office : Actipole 25 4-6 bd de Beaubourg 77435 Marne La Vallée cedex 2

Tel: 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

4

Image /page/4/Picture/0 description: The image shows a logo with the letters "bmd" in a stylized font. Below the letters is a horizontal line, and beneath that line is the text "biomedical diagnostics" in a smaller, sans-serif font. The logo appears to be for a biomedical diagnostics company.

6) Technological characteristics

The following table summarizes similarities and differences between the modified FIDIS™ CONNECTIVE 10 and the predicate device FIDIS™ CONNECTIVE 10 (K071210).

Comparison with the predicate
		Predicate Device
FIDIS™ CONNECTIVE 10
K071210	Modified Device
FIDIS™ CONNECTIVE 10
Intended use		Individual determination in human serum of
IgG antibodies against:
dsDNA, SSA 60kDa, SSA 52kDa, SSB,
Sm, Sm/RNP, Sc170, Jo-1, Ribosome and
centromere	(Minor text change)
Individual determination in human serum of
IgG antibodies against:
dsDNA, SS-A 60kDa, TRIM 21 (SS-A
52kDa), SS-B, Sm, Sm/RNP, Scl-70, Jo-1,
Ribosomes and centromere
CUT-OFF	Negative	40
for the 10 specificities	Same
Beads		Vial of color-coded microsphere set
Lyophilized
(Sufficient quantity to obtain 6mL after
reconstitution)	Same
Sample dilution		Sample dilution buffer ready to use (B)	(Minor text change)
Sample dilution buffer ready to use (B1)
Washing buffer		Washing buffer ready to use (C)	(Minor text change)
Washing buffer ready to use (C1)
Internal standard
beads		Yes	Same
Reconstitution buffer
for the
microsphere set		Vial (D) of reconstitution buffer for the
microsphere set
Ready to use (6mL)	Same
Assay configuration		1 "reagent-blank" well
1 "negative control" well
1 "positive control" well
2 "calibrator" wells
Diluted sample wells	Same
Incubation time		2 x 30min. RT	Same
Assay protocol		Final wash step	Same
Software		MLX-Booster Version 2.2	Same
Assay technology		Flow cytometry	Same
Number of reading
microspheres per
parameter		200	100
Reading time		60 seconds	90 seconds
Microplate scaling
films		6	No
Sample delivery		Manual pipetting	Same
Automated sample
delivery (option)		CARIS™ (pipettor)	Same

S.A au Capital de 2 755.46 Euros RCS Meaux: B 339 685 612 Siret: 339 685 612 00048-APE: 514N Nº TVA Intracommunautaire: FR 68 339 685 612

Registered Office Actipole 25 4-6 bd de Beaubourg 77435 Marne La Vallée cedex 2

Fax : 33 (0)1 64 62 09 66 Email: hind@bmd-net.com Internet : www.bmd-net.com

5

7) Performance Characteristics

7.1. Precision study - Using Manual Pipetting

Precision of the assay was assessed in using 6 samples for each of 7 analytes (dsDNA, SS-A 60kDa & TRIM 21 (SS-A 52 kDa), SS-B, Sm, Sm/RNP, Jo-1 and CENP-B) and only in using 5 samples for Scl-70 and Ribosomes. Precision was determined by calculating the within-run (intra-assay) and the between-run (inter-assay).

For within-run: 10 tests in a same run. ト
For between-run: 5 runs, 1 test per run. -

	dsDNA, SS-A 60kDa & TRIM 21 (SS-A 52 kDa), SS-B, Sm, Sm/RNP, Scl-70, Jo-1, Ribosomes and Centromere analytes
Sample range	Within-run		Between-run
	Minimal %CV	Maximal %CV	Minimal %CV	Maximal %CV
≤ 29 AU/mL or IU/mL	4%	15%	6%	15%
30 to 400 AU/mL or IU/mL	1%	10%	3%	15%

Table 1: Summary of FIDIS™ CONNECTIVE 10 precision results using Manual Pipetting

7.2. Comparison study with predicate - Using Manual Pipetting

bmd has compared the results obtained with modified FIDIS™ CONNECTIVE 10 versus the results obtained with predicate FIDISTM CONNECTIVE 10 K071210.

The study was performed on 80 samples characterized with the predicate test and the result repartition is described below:

77 samples were positive for one or more parameters (see ● table 3)
3 negative samples.

S.A au Capital de 2 755.46 Euros RCS Meaux: B 339 685 612 Siret: 339 685 612 00048-APE: 514N Nº TVA Intracommunautaire: FR 68 339 685 612

Registered Office : Actipole 25 4-6 bd de Beaubourg 77435 Marne La Vallée cedex 2

Tel: 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

6

First set of measures based on included the equivocal results with the test negative a. · results.

Ə dsDNA

| | | PREDICATE FIDIS™
CONNECTIVE 10
K071210 | | |
|----------------------------------------|-------|----------------------------------------------|-----|-------|
| dsDNA | | Pos | Neg | Total |
| MODIFIED
FIDIS™
CONNECTIVE
10 | Pos | 16 | 1 | 17 |
| | Neg | 0 | 63 | 63 |
| | Total | 16 | 64 | 80 |
| SS-A 60kDa | | PREDICATE FIDIS™
CONNECTIVE 10
K071210 | | |
| | | Pos | Neg | Total |
| MODIFIED
FIDIS™
CONNECTIVE | Pos | 25 | 1 | 26 |
| | Neg | 0 | 54 | 54 |

There was 1 equivocal result with the assay. For purposes of calculation, this result was considered to be negative.

Positive percent agreement: 100% (16/16)
Negative percent agreement: 98.4% (63/64)
Overall agreement: 98.8% (79/80)

> TRIM 21 (SS-A 52kDa)

| TRIM 21 (SS-A
52kDa) | | PREDICATE FIDIS™
CONNECTIVE 10
K071210 | | |
|----------------------------------------|-------|----------------------------------------------|-----|-------|
| | | Pos | Neg | Total |
| MODIFIED
FIDIS™
CONNECTIVE
10 | Pos | 23 | 0 | 23 |
| | Neg | 1 | 56 | 57 |
| | Total | 24 | 56 | 80 |

There were 3 equivocal results with the assay. For purposes of calculation, these results were considered to be negative.

Positive percent agreement: 95.8% (23/24)
Negative percent agreement: 100% (56/56)
Overall agreement: 98.8% (79/80)

→ Sm

| Sm | | PREDICATE FIDIST™
CONNECTIVE 10
K071210 | | |
|-----------------------------------------|-------|-----------------------------------------------|-----|-------|
| | | Pos | Neg | Total |
| MODIFIED
FIDIST™
CONNECTIVE
10 | Pos | 17 | 0 | 17 |
| | Neg | 0 | 63 | 63 |
| | Total | 17 | 63 | 80 |

There was 1 equivocal result with the assay. For purposes of calculation, this result was considered to be negative.

Positive percent agreement: 100% (17/17)
Negative percent agreement: 100% (63/63)
Overall agreement: 100% (80/80)

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Nº TVA Intracommunautaire: FR 68 339 685 612

<> SS-A 60kDa

| SS-A 60kDa | | CONNECTIVE 10
K071210 | | |
|----------------------------------------|-------|--------------------------|-----|-------|
| | | Pos | Neg | Total |
| MODIFIED
FIDIS™
CONNECTIVE
10 | Pos | 25 | 1 | 26 |
| | Neg | 0 | 54 | 54 |
| | Total | 25 | 55 | 80 |

There were 4 equivocal results with the assay, For purposes of calculation, these results were considered to be negative.

Positive percent agreement: 100% (25/25)
Negative percent agreement: 98.2% (54/55)
Overall agreement: 98.8% (79/80)

= SS-B

| SS-B | | PREDICATE FIDIS TM
CONNECTIVE 10
K071210 | | |
|---------------------------------------------|-------|---------------------------------------------------|-----|-------|
| | | Pos | Neg | Total |
| MODIFIED
FIDIS TM
CONNECTIVE
10 | Pos | 14 | 1 | 15 |
| | Neg | 0 | 65 | 65 |
| | Total | 14 | 66 | 80 |

There were 5 equivocal results with the assay. For purposes of calculation, these results were considered to be negative.

Positive percent agreement: 100% (14/14)
Negative percent agreement: 98.5% (65/66)
Overall agreement: 98.8% (79/80)

<> Sm/RNP

| | PREDICATE FIDIST™
CONNECTIVE 10
K071210 | | | |
|-----------------------------------------|-----------------------------------------------|-----|-------|----|
| Sm/RNP | Pos | Neg | Total | |
| MODIFIED
FIDIST™
CONNECTIVE
10 | Pos | 19 | 1 | 20 |
| | Neg | 0 | 60 | 60 |
| | Total | 19 | 61 | 80 |

There were 3 equivocal results with the assay. For purposes of calculation, these results were considered to be negative.

Positive percent agreement: 100% (19/19)
Negative percent agreement: 98.4% (60/61)
Overall agreement: 98.8% (79/80)

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7

Image /page/7/Picture/0 description: The image shows a logo for "bmd biomedical diagnostics". The logo consists of the letters "bmd" in a stylized font, with a line underneath. Below the line, the words "biomedical diagnostics" are written in a smaller, sans-serif font. The logo is simple and clean, and the use of the lowercase letters gives it a modern look.

=> Scl-70

| Scl-70 | | PREDICATE FIDIS™
CONNECTIVE 10
K071210 | | |
|----------------------------------------|-------|----------------------------------------------|-----|-------|
| | | Pos | Neg | Total |
| MODIFIED
FIDIS™
CONNECTIVE
10 | Pos | 15 | 2 | 17 |
| | Neg | 0 | 63 | 63 |
| | Total | 15 | 65 | 80 |

There were 2 equivocal results with the assay. For purposes of calculation, these results were considered to be negative.

Positive percent agreement: 100% (15/15)
Negative percent agreement: 96.9% (63/65)
Overall agreement: 97.5% (78/80)

CENP-B

| CENP-B | | PREDICATE FIDIS™
CONNECTIVE 10
K071210 | | |
|----------------------------------------|-------|----------------------------------------------|-----|-------|
| | | Pos | Neg | Total |
| MODIFIED
FIDIS™
CONNECTIVE
10 | Pos | 7 | 1 | 8 |
| | Neg | 0 | 72 | 72 |
| | Total | 7 | 73 | 80 |

There was 1 equivocal result with the assay. For purposes of calculation, this result was considered to be negative.

Positive percent agreement: 100% (7/7)
Negative percent agreement: 98.6% (72/73)
Overall agreement: 98.8% (79/80)

Jo-1

| Jo-1 | | PREDICATE FIDIS™
CONNECTIVE 10
K071210 | | |
|----------------------------------------|-------|----------------------------------------------|-----|-------|
| | | Pos | Neg | Total |
| MODIFIED
FIDIS™
CONNECTIVE
10 | Pos | 10 | 0 | 10 |
| | Neg | 0 | 70 | 70 |
| | Total | 10 | 70 | 80 |

There were 2 equivocal results with the assay. For purposes of calculation, these results were considered to be negative.

Positive percent agreement: 100% (10/10)
Negative percent agreement: 100% (70/70)
Overall agreement: 100% (80/80)

⇒ Ribosomes

| Ribosomes | | PREDICATE FIDIS™
CONNECTIVE 10
K071210 | | |
|----------------------------------------|-------|----------------------------------------------|-----|-------|
| | | Pos | Neg | Total |
| MODIFIED
FIDIS™
CONNECTIVE
10 | Pos | 6 | 0 | 6 |
| | Neg | 0 | 74 | 74 |
| | Total | 6 | 74 | 80 |

There was 1 equivocal result with the assay. For purposes of calculation, this result was considered to be negative.

Positive percent agreement: 100% (6/6)
Negative percent agreement: 100% (74/74)
Overall agreement: 100% (80/80)

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8

b. Second set of measures based on included the equivocal results with the test positive results.

> dsDNA

| dsDNA | | PREDICATE FIDISTM
CONNECTIVE 10
K071210 | | |
|-----------------------------------------|-------|-----------------------------------------------|-----|-------|
| | | Pos | Neg | Total |
| MODIFIED
FIDISTM
CONNECTIVE
10 | Pos | 17 | 0 | 17 |
| | Neg | 0 | 63 | 63 |
| | Total | 17 | 63 | 80 |
| SS-A 60kDa | | PREDICATE FIDIS™
CONNECTIVE 10
K071210 | | |
| | | Pos | Neg | Total |
| MODIFIED
FIDIS™
CONNECTIVE
10 | Pos | 29 | 0 | 29 |
| | Neg | 0 | 51 | 51 |
| | Total | 29 | 51 | 80 |

=> SS-A 60kDa

There were 4 equivocal results with the assay. For purposes of

calculation, these results were considered to be negative.

Positive percent agreement: 100% (29/29)
Negative percent agreement: 100% (51/51)
Overall agreement: 100% (80/80)

There was 1 equivocal result with the assay, For purposes of calculation, this result is considered to be positive.

Positive percent agreement: 100% (17/17)
Negative percent agreement: 100% (63/63)
Overall agreement: 100% (80/80)

<> TRIM 21 (SS-A 52kDa)

| TRIM 21
(SS-A 52kDa) | | PREDICATE FIDIS™
CONNECTIVE 10
K071210 | | |
|----------------------------------------|-------|----------------------------------------------|-----|-------|
| | | Pos | Neg | Total |
| MODIFIED
FIDIS™
CONNECTIVE
10 | Pos | 25 | 1 | 26 |
| | Neg | 0 | 54 | 54 |
| | Total | 25 | 55 | 80 |

There were 3 equivocal results with the assay. For purposes of calculation, these results were considered to be negative.

· Positive percent agreement: 100% (25/25)

Negative percent agreement: 98.2% (54/55)
Overall agreement: 98.8% (79/80)

Sm/RNP

| Sm/RNP | | PREDICATE FIDIS™
CONNECTIVE 10
K071210 | | |
|----------------------------------------|-------|----------------------------------------------|-----|-------|
| | | Pos | Neg | Total |
| MODIFIED
FIDIS™
CONNECTIVE
10 | Pos | 20 | 1 | 21 |
| | Neg | 1 | 58 | 59 |
| | Total | 21 | 59 | 80 |

There were 3 equivocal results with the assay. For purposes of calculation, these results were considered to be negative.

. Positive percent agreement: 95.2% (20/21)
Negative percent agreement: 98.3% (58/59)
Overall agreement: 97.5% (78/80)

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9

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| Scl-70 | | | PREDICATE FIDIS™
CONNECTIVE 10
K071210 | | |
|----------------------------|-------|-----|----------------------------------------------|-------|--|
| | | Pos | Neg | Total | |
| MODIFIED | Pos | 17 | 0 | 17 | |
| FIDIS™
CONNECTIVE
10 | Neg | 0 | 63 | 63 | |
| | Total | 17 | 63 | 80 | |

There were 2 equivocal results with the assay. For purposes of calculation, these results were considered to be negative.

Positive percent agreement: 100% (17/17)
Negative percent agreement: 100% (63/63)
Overall agreement: 100% (80/80)

⇒ CENP-B

| CENP-B | | PREDICATE FIDIS™
CONNECTIVE 10
K071210 | | | |
|----------------------------------------|-------|----------------------------------------------|----------------------------------------------|-------|-------|
| | | Pos | Neg | Total | |
| MODIFIED
FIDIS™
CONNECTIVE
10 | Pos | 8 | 0 | 8 | |
| | Neg | 0 | 72 | 72 | |
| | Total | 8 | 72 | 80 | |
| Jo-1 | | | PREDICATE FIDIS™
CONNECTIVE 10
K071210 | | |
| | | | Pos | Neg | Total |
| MODIFIED
FIDIS™ | Pos | 12 | 0 | 12 | |
| CONNECTIVE
10 | Neg | 0 | 68 | 68 | |
| | Total | 12 | 68 | 80 | |

There was 1 equivocal result with the assay. For purposes of calculation, this result was considered to be negative.

Positive percent agreement: 100% (8/8)
Negative percent agreement: 100% (72/72)
Overall agreement: 100% (80/80)

⇒ Jo-1

There were 2 equivocal results with the assay. For purposes of calculation, these results were considered to be negative.

· Positive percent agreement: 100% (12/12)

· Negative percent agreement: 100% (68/68)

Overall agreement: 100% (80/80)

⇒ Ribosomes

| Ribosomes | | PREDICATE FIDIS™
CONNECTIVE 10
K071210 | | |
|----------------------------------------|-------|----------------------------------------------|-----|-------|
| | | Pos | Neg | Total |
| MODIFIED
FIDIS™
CONNECTIVE
10 | Pos | 7 | 0 | 7 |
| | Neg | 0 | 73 | 73 |
| | Total | 7 | 73 | 80 |

There was ! equivocal result with the assay. For purposes of calculation, this result was considered to be negative.

· Positive percent agreement: 100% (7/7)

· Negative percent agreement: 100% (73/73)

Overall agreement: 100% (80/80)

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10

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ﺎ

| Antigenic
Specificity percent
agreement | Negative
percent
agreement | Overall
agreement | EP12-A
Chap 9.2.2. | EP12-A
Chap 9.1.1.
95%CI
For positive
agreement | EP12-A
Chap 9.1.1.
95%CI
For negative
agreement |
|----------------------------- | equivocal results included
with the test negative results | dsDNA
equivocal results Included
with the test positive results | equivocal results included
with the test negative results | SSA 60 kDa
equivocal results included
with the test positive results | TRIM 21
(SSA 52
kDa)
equivocal results included
with the test negative results | 95.8% | equivocal results included
with the test positive results | equivocal results included
with the test negative results | SSB
equivocal results included
with the test positive results | equivocal results included
with the test negative results | Sm
equivocal results included
with the test positive results | equivocal results included
with the test negative results | Sm/RNP
equivocal results included
with the test positive results | equivocal results included
with the test negative results | Sc170
equivocal results included
with the test positive results | equivocal results included
with the test negative results | Jo1
equivocal results included
with the test positive results | equivocal results Included
with the test negative results | CENP-B
equivocal results Included
with the test positive results | equivocal results Included
with the test negative results | Ribosomes
equivocal results Included
with the test positive results | Positive
---------------------------------------------------------------|----------------------------------|----------------------------------|----------------------|-----------------------|-------------------------------------------------------------|-------------------------------------------------------------|
| 100% | 98.4% | 98.8% | 87.8%-100% | NA | NA |
| 100% | 100% | 100% | NA | 81.6%-100% | 94.3%-100 |
| 100% | 98.2% | 98.8% | 86.6%-100% | NA | NA |
| 100% | 100% | 100% | NA | 88.3%-100% | 93%-100% |
| 100% | 98.8% | 86.7%-100% | NA | NA |
| 100% | 98.2% | 98.8% | 86.6%-100% | NA | NA |
| 100% | 98.5% | 98.8% | 88.2%-100% | NA | NA |
| 100% | 100% | 100% | NA | 83.2%-100% | 94.1%-100 |
| 100% | 100% | 100% | NA | 81.6%-100% | 94.3%-100% |
| 100% | 100% | 100% | NA | 82.4%-100% | 94.2%-100% |
| 100% | 98.4% | 98.8% | 87.3%-100% | NA | NA |
| 95.2% | 98.3% | 97.5% | 85.8%-100% | NA | NA |
| 100% | 96.9% | 97.5% | 86.8%-100% | NA | NA |
| 100% | 100% | 100% | NA | 81.6%-100% | 94.3%-100% |
| 100% | 100% | 100% | NA | 72.3%-100% | 94.8%-100% |
| 100% | 100% | 100% | NA | 75.8%-100% | 94.7%-100% |
| 100% | 98.6% | 98.8% | 90.2%-100% | NA | NA |
| 100% | 100% | 100% | NA | 67.6%-100% | 94.9%-100% |
| 100% | 100% | 100% | NA | 61.0%-100% | 95.1%-100% |
| 100% | 100% | 100% | NA | 64.6%-100% | 95.0%-100% |

Table 2: Summary of performance agreement results

All of results show that FIDISTM CONNECTIVE 10 considered substantially equivalent to the predicate K071210IS™ CONNECTIVE 10

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11

7.3.Performance data for modified FIDIS™ CONNECTIVE 10 with CARIS™ (diluting/ dispensing Device)

a. Precision study

Precision of the assay was assessed in using 6 samples for each of 7 analytes (dsDNA, SS-A 60kDa & TRIM 21 (SS-A 52 kDa), SS-B, Sm, Sm/RNP, Jo-1 and CENP-B) and only in using 5 samples for Scl-70 and Ribosomes. Precision was determined by calculating the within-run (intra-assay) and the between-run (interassay).

-For within-run: 10 tests in a same run.
For between-run: 5 runs, 1 test per run.

	dsDNA, SS-A 60kDa & TRIM 21 (SS-A 52 kDa), SS-B, Sm, Sm/RNP, Scl-70, Jo-1 Ribosomes and Centromere analytes
Sample range	Within-run	Between-run
	Minimal %CV	Maximal %CV	Minimal %CV	Maximal %CV
≤ 29 AU/mL or
IU/mL	8%	13%	6%	15%
30 to 400 AU/mL or
IU/mL	3%	10%	2%	15%

Table 3: Summary of CARISTM precision results

b. Comparison studies (manual versus automated assay preparation steps)
bmd has compared the results obtained with modified FIDISTM CONNECTIVE 10 for manual or automated (with CARIS™).assay preparation steps.

The study was performed on 80 samples characterized with the predicate test and the result repartition is described below:

77 samples were positive for one or more parameters . (see table 10)
3 negative samples. .

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12

bmd
biomedical diagnostics

a. First set of measures based on included the equivocal results with the test negative results.

ď dsDNA

	dsDNA
		MODIFIED FIDIS™
CONNECTIVE 10
Manual Use
		Pos	Neg	Total
MODIFIED
FIDIS™	Pos	16	1	17
CONNECTIVE
10
With CARIS™	Neg	0	63	63
	Total	16	64	80

There was 1 equivocal result with the assay. For purposes of calculation, this result was considered to be negative.

Positive percent agreement: 100% (16/16)
Negative percent agreement: 98.4% (63/64)
Overall agreement: 98.8% (79/80)

=> TRIM 21 (SS-A 52kDa)

| TRIM 21
(SS-A 52kDa) | | MODIFIED FIDIS™
CONNECTIVE 10
Manual Use | | |
|-------------------------------------------------------|-------|------------------------------------------------|-----|-------|
| | | Pos | Neg | Total |
| MODIFIED
FIDIS™
CONNECTIVE
10
With CARIS™ | Pos | 23 | 1 | 24 |
| | Neg | 0 | 56 | 56 |
| | Total | 23 | 57 | 80 |

There were 3 equivocal results with the assay. For purposes of calculation, these results were considered to be negative.

Positive percent agreement: 100% (22/22)
Negative percent agreement: 98.3% (57/58)
Overall agreement: 98.8% (79/80)

Ə Sm

| Sm | | MODIFIED FIDIS™
CONNECTIVE 10
Manual Use | | |
|-------------------------------------------------------|-------|------------------------------------------------|-----|-------|
| | | Pos | Neg | Total |
| MODIFIED
FIDIS™
CONNECTIVE
10
With CARIS™ | Pos | 16 | 1 | 17 |
| | Neg | 0 | 63 | 63 |
| | Total | 16 | 64 | 80 |
| SS-A 60kDa | | MODIFIED FIDIS™
CONNECTIVE 10
Manual Use | | |
| | | Pos | Neg | Total |
| MODIFIED
FIDIS™
CONNECTIVE
10
With CARIS™ | Pos | 26 | 1 | 27 |
| | Neg | 0 | 53 | 53 |
| | Total | 26 | 54 | 80 |

There was 1 equivocal result with the assay. For purposes of calculation, this result was considered to be negative.

Positive percent agreement: 100% (16/16)
Negative percent agreement: 98.4% (63/64)
Overall agreement: 98.8% (79/80)

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SS-B

| SS-B | | MODIFIED FIDIS™
CONNECTIVE 10
Manual Use | | |
|-------------------------------------------------------|-------|------------------------------------------------|-----|-------|
| | | Pos | Neg | Total |
| MODIFIED
FIDIS™
CONNECTIVE
10
With CARIS™ | Pos | 15 | 0 | 15 |
| | Neg | 0 | 65 | 65 |
| | Total | 15 | 65 | 80 |

There were 4 equivocal results with the assay. For purposes of calculation, these results were considered to be negative.

· Positive percent agreement: 100% (15/15)

Negative percent agreement: 100% (65/65)
Overall agreement: 100% (80/80)

⇒ Sm/RNP

| Sm/RNP | | MODIFIED FIDIS™
CONNECTIVE 10
Manual Use | | |
|---------------------------------|-------|------------------------------------------------|-----|-------|
| | | Pos | Neg | Total |
| MODIFIED
FIDIS™ | Pos | 20 | 0 | 20 |
| CONNECTIVE
10
With CARIS™ | Neg | 0 | 60 | 60 |
| | Total | 20 | 60 | 80 |

There was 1 equivocal result with the assay. For purposes of calculation, this result was considered to be negative.

Positive percent agreement: 100% (20/20)
Negative percent agreement: 100% (60/60)
Overall agreement: 100% (80/80)
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13

<> Scl-70

| Scl-70 | MODIFIED FIDIS™
CONNECTIVE 10
Manual Use | | | |
|-------------------------------------------------------|------------------------------------------------|-----|-------|----|
| | Pos | Neg | Total | |
| MODIFIED
FIDIS™
CONNECTIVE
10
With CARIS™ | Pos | 15 | 2 | 17 |
| | Neg | 0 | 63 | 63 |
| | Total | 15 | 65 | 80 |

There were 2 equivocal results with the assay. For purposes of calculation, these results were considered to be negative.

Positive percent agreement: 100% (15/15)
Positive percent agreement: 100% (15/15)
Negative percent agreement: 96.9% (63/65)
Overall agreement: 97.5% (78/80)

→ CENP-B

| CENP-B | | MODIFIED FIDIST™
CONNECTIVE 10
Manual Use | | |
|-------------------------------------------------------|-------|-------------------------------------------------|-----|-------|
| | | Pos | Neg | Total |
| MODIFIED
FIDIST™ | Pos | 8 | 0 | 8 |
| CONNECTIVE
10
With CARIST™ | Neg | 0 | 72 | 72 |
| | Total | 8 | 72 | 80 |
| Jo-1 | | MODIFIED FIDIS™
CONNECTIVE 10
Manual Use | | |
| | | Pos | Neg | Total |
| MODIFIED
FIDIS™
CONNECTIVE
10
With CARIS™ | Pos | 10 | 0 | 10 |
| | Neg | 0 | 70 | 70 |
| | Total | 10 | 70 | 80 |

There was I equivocal result with the assay. For purposes of calculation, this result was considered to be negative.

Positive percent agreement: 100% (8/8)
Negative percent agreement: 100% (72/72)
Overall agreement: 100% (80/80)

다 Jo-1

There were 2 equivocal results with the assay. For purposes of calculation, these results were considered to be negative.

Positive percent agreement: 100% (10/10)
Negative percent agreement: 100% (70/70)
Negative percent agreement: 100% (70/70)
Overall agreement: 100% (80/80)

⇒ Ribosomes

| Ribosomes | | MODIFIED FIDIST™
CONNECTIVE 10
Manual Use | | |
|---------------------------------|-------|-------------------------------------------------|-----|-------|
| | | Pos | Neg | Total |
| MODIFIED
FIDIST™ | Pos | 6 | 0 | 6 |
| CONNECTIVE
10
With CARIS™ | Neg | 0 | 74 | 74 |
| | Total | 6 | 74 | 80 |

There was 1 equivocal result with the assay. For purposes of calculation, this result was considered to be negative.

· Positive percent agreement: 100% (6/6)

Negative percent agreement: 100% (74/74)
Overall agreement: 100% (80/80)

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14

b. Second set of measures based on included the equivocal results with the test positive results.

SS-A 60kDa

<> dsDNA

| dsDNA | | MODIFIED FIDIS™
CONNECTIVE 10
Manual Use | | |
|-------------------------------------------------------------|-------|------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------|
| | | Pos | Neg | Total |
| MODIFIED
FIDISTM
CONNECTIVE Neg
10
With CARISTM | Pos | 17 | 0 | 17 |
| | | 0 | ર્ણ રેજે રહ્યું હતું. સ્વર્ગ સાચના હતું રેતા પાસની વિદ્યોગના વિદ્યોગના વિદ્યારે તે જે તે આ ગામનાં છે તે આ ગામનાં છે તે આ ગામનાં છે તે આ ગામનાં છે છે. આ ગામનાં પ્રાથમિક શાળા, | 63 |
| | Total | 17 | ર્ભ રેસ | 80 |

MODIFIED FIDISTM CONNECTIVE 10 SS-A 60kDa Manual Use

There was i equivocal result with the assay. For purposes of calculation, this result is considered to be positive.

Positive percent agreement: 100% (17/17)
Negative percent agreement: 100% (63/63)
Overall agreement: 100% (80/80)

→ TRIM 21 (SS-A 52kDa)

| TRIM 21
(SS-A 52kDa) | | MODIFIED FIDIS™
CONNECTIVE 10
Manual Use | | |
|-------------------------------------------------------|-------|------------------------------------------------|-----|-------|
| | | Pos | Neg | Total |
| MODIFIED
FIDIS™
CONNECTIVE
10
With CARIS™ | Pos | 26 | 0 | 26 |
| | Neg | 0 | 54 | 54 |
| | Total | 26 | 54 | 80 |

There were 3 equivocal results with the assay. For purposes of calculation, these results were considered to be negative.

Positive percent agreement: 100% (26/26)
Negative percent agreement: 100% (54/54) ·
Overall agreement: 100% (80/80)

SS-B

| SS-B | | MODIFIED FIDIS™
CONNECTIVE 10
Manual Use | | |
|---------------------------------|-------|------------------------------------------------|-----|-------|
| | | Pos | Neg | Total |
| MODIFIED
FIDISTM | Pos | 17 | 2 | 19 |
| CONNECTIVE
10
With CARIS™ | Neg | 0 | 61 | 61 |
| | Total | 17 | 63 | 80 |

There were 4 equivocal results with the assay. For purposes of calculation, these results were considered to be negative.

Positive percent agreement: 100% (17/17)

· Negative percent agreement: 96.8% (61/63)

Overall agreement: 97.5% (78/80)

<> Sm/RNP

| Sm/RNP | | MODIFIED FIDIS™
CONNECTIVE 10
Manual Use | | |
|---------------------------------|-------|------------------------------------------------|-----|-------|
| | | Pos | Neg | Total |
| MODIFIED
FIDIS™ | Pos | 20 | 0 | 20 |
| CONNECTIVE
10
With CARIS™ | Neg | 1 | 59 | 60 |
| | Total | 21 | 59 | 80 |

There was 1 equivocal result with the assay. For purposes of calculation, this result is considered to be positive.

Positive percent agreement: 95.2% (20/21)
Negative percent agreement: 100% (59/59)
Overall agreement: 98.8% (79/80)

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15

<> Scl-70

| Scl-70 | | MODIFIED FIDIS™
CONNECTIVE 10
Manual Use | | |
|--------------------------------------------------------|-------|------------------------------------------------|-----|-------|
| | | Pos | Neg | Total |
| MODIFIED
FIDIS™
CONNECTIVE
10
With CARISTM | Pos | 17 | 0 | 17 |
| | Neg | 0 | 63 | 63 |
| | Total | 17 | 63 | 80 |

There were 2 equivocal results with the assay. For purposes of calculation, these results were considered to be negative.

Positive percent agreement: 100% (17/17)
Negative percent agreement: 100% (63/63)
Overall agreement: 100% (80/80)

→ CENP-B

| CENP-B | | MODIFIED FIDIS™
CONNECTIVE 10
Manual Use | | |
|-------------------------------------------------------|-------|------------------------------------------------|-----|-------|
| | | Pos | Neg | Total |
| MODIFIED
FIDIS™
CONNECTIVE
10
With CARIS™ | Pos | 8 | 1 | 9 |
| | Neg | 0 | 71 | 71 |
| | Total | 8 | 72 | 80 |

There was I equivocal result with the assay. For purposes of calculation, this result was considered to be negative.

Positive percent agreement: 100% (8/8)
Negative percent agreement: 98.6% (71/72)
Overall agreement: 98.8% (79/80)

⇒ Jo-1

| Jo-1 | | MODIFIED FIDIS™
CONNECTIVE 10
Manual Use | | |
|-------------------------------------------------------|-------|------------------------------------------------|-----|-------|
| | | Pos | Neg | Total |
| MODIFIED
FIDIS™
CONNECTIVE
10
With CARIS™ | Pos | 12 | 0 | 12 |
| | Neg | 0 | 68 | 68 |
| | Total | 12 | 68 | 80 |

There were 2 equivocal results with the assay. For purposes of calculation, these results were considered to be negative.

. - Positive percent agreement: 100% (12/12)

Negative percent agreement: 100% (68/68)
Overall agreement: 100% (80/80)

⇒ Ribosomes

Ribosomes	MODIFIED FIDIS™ CONNECTIVE 10 Manual Use
	Pos	Neg	Total
MODIFIED
FIDIS™
CONNECTIVE
10	Pos	7	0	7
	Neg	0	73	73
	Total	7	73	80

There was 1 equivocal result with the assay. For purposes of calculation, this result was considered to be negative.

Positive percent agreement: 100% (7/7)
Negative percent agreement: 100% (73/73)
Overall agreement: 100% (80/80)

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16

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| Antigenic
Specificity | | Positive
percent
agreement | Negative
percent
agreement | Overall
agreement | EP12-A
Chap 9.2.2. | EP12-A
Chap 9.1.1. | EP12-A
Chap 9.1.1. |
|----------------------------|--------------------------------------------------------------|----------------------------------|----------------------------------|----------------------|-----------------------|-------------------------------------|-------------------------------------|
| | | proportion | proportion | proportion | 95% CI | 95% CI
For positive
agreement | 95% CI
For negative
agreement |
| dsDNA | equivocal results included
with the test negative results | 100% | 98.4% | 98.8% | 87.8%-100% | NA | NA |
| | equivocal results included
with the test positive results | 100% | 100% | 100% | NA | 81.6%-100% | 94.3%-100 |
| SSA 60 kDa | equivocal results included
with the test negative results | 100% | 98.1% | 98.8% | 86.5%-100% | NA | NA |
| | equivocal results included
with the test positive results | 100% | 100% | 100% | NA | 88.3%-100% | 93%-100% |
| TRIM 21
(SSA 52
kDa) | equivocal results included
with the test negative results | 100% | 98.3% | 98.8% | 86.8%-100% | NA | NA |
| | equivocal results included
with the test positive results | 100% | 100% | 100% | NA | 87.1%-100% | 93.4%-100 |
| SSB | equivocal results included
with the test negative results | 100% | 100% | 100% | NA | 79.6%-100% | 94.4%-100% |
| | equivocal results included
with the test positive results | 100% | 96.8% | 97.5% | 86.5%-100% | NA | NA |
| Sm | equivocal results included
with the test negative results | 100% | 98.4% | 98.8% | 87.8%-100% | NA | NA |
| | equivocal results included
with the test positive results | 100% | 100% | 100% | NA | 81.6%-100% | 94.3%-100 |
| Sm/RNP | equivocal results included
with the test negative results | 100% | 100% | 100% | NA | 83.9%-100% | 94.0%-100% |
| | equivocal results included
with the test positive results | 95.2% | 100% | 98.8% | 87%-100% | NA | NA |
| Sc170 | equivocal results included
with the test negative results | 100% | 96.9% | 97.5% | 86.8%-100% | NA | NA |
| | equivocal results included
with the test positive results | 100% | 100% | 100% | NA | 81.6%-100% | 94.3%-100% |
| Jo1 | equivocal results included
with the test negative results | 100% | 100% | 100% | NA | 72.3%-100% | 94.8%-100% |
| | equivocal results included
with the test positive results | 100% | 100% | 100% | NA | 75.8%-100% | 94.7%-100% |
| CENP-B | equivocal results included
with the test negative results | 100% | 100% | 100% | NA | 67.6%-100% | 94.9%-100% |
| | equivocal results included
with the test positive results | 100% | 98.6% | 98.8% | 89.8%-100% | NA | NA |
| Ribosomes | equivocal results included
with the test negative results | 100% | 100% | 100% | NA | 61.0%-100% | 95.1%-100% |
| | equivocal results included
with the test positive results | 100% | 100% | 100% | NA | 64.6%-100% | 95.0%-100% |

Table 4: Summary of performance agreements results obtained with CARIS™ versus manual

All of previous evaluations results indicate that manual and automated (with CARISTM) assay preparation steps are considered substantially equivalents.

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8) Conclusions

=> In conclusion, all supporting data demonstrate that the FIDIS™ CONNECTIVE 10 system can be considered substantially equivalent to the predicate device.

=> All comparative studies indicate that manual and automated (with CARIS™) assays provide results that are statistically comparable.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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Food & Drug Administration 10903 New Hampshire Avenue Building 66 Silver Spring, MD 20993

Biomedical Diagnostics (bmd) S.A. c/o Ms. Christelle Courivaud Regulatory Manager Actipole 25, 4-6 bd de Beaubourg 77435 Marne-La-Vallée Cedex 2 FRANCE

DEC 0 3 2010

Re: K102607

Trade/Device Name: FIDIS™ CONNECTIVE 10 Regulation Number: 21 CFR §866.5100 Regulation Name: Antinuclear Antibody, immunological test systems Regulatory Class: Class II Product Codes: LLL, LKJ, LKO, LKP, LSW, LJM, MQA Dated: October 29, 2010 Received: November 1, 2010

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 class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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

19

Page 2 - Ms. Christelle Courivaud

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 Parts 801 and 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). 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 Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Reache R. Si

Maria Chan, Ph.D. tor Director Division of Immunology and Hematology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

20

Indication for Use

510(k) Number (if known): K102607 DEC - 3 2010

Device Name: .

FIDIS™ CONNECTIVE 10

Indication For Use:

The FIDIS™ CONNECTIVE 10* kit is a semi-quantitative homogeneous fluorescent-based microparticles immunoassay using flow cytometry. The test system is used to simultaneously detect the presence of 10 autoantibody specificities: double stranded DNA (dsDNA), SS-A (60kDa and TRIM 21 (SS-A 52kDa)), SS-B, Sm, Sm/RNP, Scl-70, Jo-1, ribosomes and centromere (CENP-B).

(*Antibodies to dsDNA, Sm, Sm/RNP, SS-A, SS-B, Scl-70, Jo-1, ribosomes and CENP-B can be reported using this assay).

Clinical utility:

The results of the FIDIS™ CONNECTIVE 10 are to be used in conjunction with the clinical findings and the other laboratory tests to aid in the diagnosis of connective diseases (systemic lupus erythematosus (SLE), Sjogren's syndrome, mixed connective tissue disease (MCTD), scleroderma, dermatomyositis and CREST syndrome).

FIDIS™ CONNECTIVE 10 kit uses serum only, and is to be run on the FIDIS™ Instrument and MLX-BOOSTERTM Software.

FIDIS™ CONNECTIVE 10 kit may be used with the CARIS™ system (diluting and dispensing device).

This kit is for In vitro Diagnostic Use.

Prescription Use X (21 CFR Part 801 Subpart D) And/Or

Over the Counter Use (21 CFR Part 801 Subpart C)

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

Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OVD)

Reena Philip

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety