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-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.

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.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study details for the FIDIS™ CONNECTIVE 10 Assay kit:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the modified FIDIS™ CONNECTIVE 10 assay were based on demonstrating substantial equivalence to the predicate device (K071210). This was primarily assessed through agreement studies, ensuring high Positive Percent Agreement (PPA), Negative Percent Agreement (NPA), and Overall Agreement.

The document reports two main studies:

Comparison Study with Predicate - Using Manual Pipetting: This compares the modified device against the predicate device.
Performance Data for Modified FIDIS™ CONNECTIVE 10 with CARIS™ (diluting/dispensing Device): This compares the modified device using automated (CARIS™) versus manual assay preparation steps.

Below is a summary of the reported performance for each antigenic specificity from the "Comparison study with predicate - Using Manual Pipetting" (equivocal results considered negative, as presented in the first set of measures, which typically represents a more conservative approach). Similar performance was observed when equivocal results were considered positive, and across the CARIS™ system comparisons.

Antigenic Specificity	Acceptance Criteria (Implicit: High Agreement)	Reported Positive Percent Agreement (PPA)	Reported Negative Percent Agreement (NPA)	Reported Overall Agreement
dsDNA	High Agreement (vs. Predicate)	100%	98.4%	98.8%
SS-A 60kDa	High Agreement (vs. Predicate)	100%	98.2%	98.8%
TRIM 21 (SS-A 52kDa)	High Agreement (vs. Predicate)	95.8%	100%	98.8%
Sm	High Agreement (vs. Predicate)	100%	100%	100%
SS-B	High Agreement (vs. Predicate)	100%	98.5%	98.8%
Sm/RNP	High Agreement (vs. Predicate)	100%	98.4%	98.8%
Scl-70	High Agreement (vs. Predicate)	100%	96.9%	97.5%
CENP-B	High Agreement (vs. Predicate)	100%	98.6%	98.8%
Jo-1	High Agreement (vs. Predicate)	100%	100%	100%
Ribosomes	High Agreement (vs. Predicate)	100%	100%	100%

Note: The document implicitly defines "high agreement" as meeting the criteria for substantial equivalence to the predicate device. Specific numerical thresholds for agreement were not explicitly stated as acceptance criteria in the document, but the consistent high percentages demonstrate that the device met the expectation for equivalence.

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

Sample Size for Test Set: 80 samples for each comparison study (77 positive for one or more parameters, 3 negative samples).
Data Provenance: The document does not explicitly state the country of origin for the samples used in the comparison studies. It also does not specify if the data was retrospective or prospective, though it appears to be retrospective as the samples were "characterized with the predicate test."

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

The document does not mention the use of experts to establish ground truth for the test set. The comparison studies used the results from the predicate device (FIDIS™ CONNECTIVE 10 K071210) as the comparator (reference standard) for calculating agreement.

4. Adjudication Method for the Test Set

There was no human adjudication for the test set. Equivocal results were handled by being considered either negative or positive for calculation purposes, and both scenarios were presented.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This is an in vitro diagnostic (IVD) assay kit for autoantibody detection, not an AI-assisted diagnostic imaging device that involves human readers.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

This is an in vitro diagnostic immunoassay Kit. The performance described is for the device operating in a standalone manner, providing semi-quantitative results for autoantibodies in serum. There isn't a "human-in-the-loop" component in the interpretation of the assay's direct numerical output, but clinical interpretation of the results in conjunction with other findings is intended. The comparison studies effectively represent standalone performance against a predicate device.

7. The Type of Ground Truth Used

The ground truth for the comparison studies was based on the results obtained from the legally marketed predicate device: FIDIS™ CONNECTIVE 10 (K071210). This implicitly means the predicate device's results were considered the "truth" for the purpose of demonstrating substantial equivalence.

8. The Sample Size for the Training Set

The document does not specify a separate "training set" in the context of an algorithm or AI. For the precision studies, various samples were used to calculate within-run and between-run variability. For the comparison studies, 80 samples were used as the test set to compare the modified device against the predicate. This is a traditional IVD device, not an AI/ML device with distinct training and test sets in the software sense.

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

Not applicable, as there is no explicitly defined "training set" with a separate ground truth establishment process in the context of this IVD device submission. The performance assessment relies on comparison to a cleared predicate device and internal precision studies.

Summary

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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

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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 DiagnosticsS.A.(bmd)

4) Device description

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

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.

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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 52kDa), 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 useEach 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 evidenceof the proper reagents activity and proper assay performance.To be dilutedExpected values are printed on the vial label.	CONTROL +	1 × 250 µL	5 x 250µL
Vial of negative control concentrateTo be diluted	CONTROL -	1 x 250µL	5 x 250µL
Vial of anti-human IgG coupled to phycoerythrinReady 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 setReady to use	BUF MICROSPHERES	1 x 6mL	5 x 6mL

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

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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

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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 DeviceFIDIS™ CONNECTIVE 10K071210	Modified DeviceFIDIS™ CONNECTIVE 10
Intended use		Individual determination in human serum ofIgG antibodies against:dsDNA, SSA 60kDa, SSA 52kDa, SSB,Sm, Sm/RNP, Sc170, Jo-1, Ribosome andcentromere	(Minor text change)Individual determination in human serum ofIgG antibodies against:dsDNA, SS-A 60kDa, TRIM 21 (SS-A52kDa), SS-B, Sm, Sm/RNP, Scl-70, Jo-1,Ribosomes and centromere
CUT-OFF	Negative	<30for the 10 specificities	Same
	Equivocal	30-40for the 10 specificities	Same
	Positive	>40for the 10 specificities	Same
Beads		Vial of color-coded microsphere setLyophilized(Sufficient quantity to obtain 6mL afterreconstitution)	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 standardbeads		Yes	Same
Reconstitution bufferfor themicrosphere set		Vial (D) of reconstitution buffer for themicrosphere setReady to use (6mL)	Same
Assay configuration		1 "reagent-blank" well1 "negative control" well1 "positive control" well2 "calibrator" wellsDiluted 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 readingmicrospheres perparameter		200	100
Reading time		60 seconds	90 seconds
Microplate scalingfilms		6	No
Sample delivery		Manual pipetting	Same
Automated sampledelivery (option)		CARIS™ (pipettor)	Same

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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.

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

Ə dsDNA

		PREDICATE FIDIS™CONNECTIVE 10K071210
dsDNA		Pos	Neg	Total
MODIFIEDFIDIS™CONNECTIVE10	Pos	16	1	17
	Neg	0	63	63
	Total	16	64	80
SS-A 60kDa		PREDICATE FIDIS™CONNECTIVE 10K071210
		Pos	Neg	Total
MODIFIEDFIDIS™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-A52kDa)		PREDICATE FIDIS™CONNECTIVE 10K071210
		Pos	Neg	Total
MODIFIEDFIDIS™CONNECTIVE10	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 10K071210
		Pos	Neg	Total
MODIFIEDFIDIST™CONNECTIVE10	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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<> SS-A 60kDa

SS-A 60kDa		CONNECTIVE 10K071210
		Pos	Neg	Total
MODIFIEDFIDIS™CONNECTIVE10	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 TMCONNECTIVE 10K071210
		Pos	Neg	Total
MODIFIEDFIDIS TMCONNECTIVE10	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 10K071210
Sm/RNP	Pos	Neg	Total
MODIFIEDFIDIST™CONNECTIVE10	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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=> Scl-70

Scl-70		PREDICATE FIDIS™CONNECTIVE 10K071210
		Pos	Neg	Total
MODIFIEDFIDIS™CONNECTIVE10	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 10K071210
		Pos	Neg	Total
MODIFIEDFIDIS™CONNECTIVE10	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 10K071210
		Pos	Neg	Total
MODIFIEDFIDIS™CONNECTIVE10	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 10K071210
		Pos	Neg	Total
MODIFIEDFIDIS™CONNECTIVE10	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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b. Second set of measures based on included the equivocal results with the test positive results.

> dsDNA

dsDNA		PREDICATE FIDISTMCONNECTIVE 10K071210
		Pos	Neg	Total
MODIFIEDFIDISTMCONNECTIVE10	Pos	17	0	17
	Neg	0	63	63
	Total	17	63	80
SS-A 60kDa		PREDICATE FIDIS™CONNECTIVE 10K071210
		Pos	Neg	Total
MODIFIEDFIDIS™CONNECTIVE10	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 10K071210
		Pos	Neg	Total
MODIFIEDFIDIS™CONNECTIVE10	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

Sm		PREDICATE FIDIST™CONNECTIVE 10K071210
		Pos	Neg	Total
MODIFIED	Pos	18	0	16
FIDIS™CONNECTIVE	Neg	0	62	64
10	Total	17	63	80

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

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

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1
---	--	--

SS-B		PREDICATE FIDIS™CONNECTIVE 10K071210
		Pos	Neg	Total
MODIFIEDFIDIST™CONNECTIVE10	Pos	19	0	19
	Neg	0	61	61
	Total	19	61	80

There were 5 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: 100% (61/61)
Overall agreement: 100% (80/80)

<> Sm/RNP

Sm/RNP		PREDICATE FIDIS™CONNECTIVE 10K071210
		Pos	Neg	Total
MODIFIEDFIDIS™CONNECTIVE10	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 10K071210
		Pos	Neg	Total
MODIFIED	Pos	17	0	17
FIDIS™CONNECTIVE10	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 10K071210
		Pos	Neg	Total
MODIFIEDFIDIS™CONNECTIVE10	Pos	8	0	8
	Neg	0	72	72
	Total	8	72	80
Jo-1			PREDICATE FIDIS™CONNECTIVE 10K071210
			Pos	Neg	Total
MODIFIEDFIDIS™	Pos	12	0	12
CONNECTIVE10	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 10K071210
		Pos	Neg	Total
MODIFIEDFIDIS™CONNECTIVE10	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

AntigenicSpecificity	Positivepercentagreement	Negativepercentagreement	Overallagreement	EP12-AChap 9.2.2.	EP12-AChap 9.1.1.95%CIFor positiveagreement	EP12-AChap 9.1.1.95%CIFor negativeagreement
equivocal results includedwith the test negative results	100%	98.4%	98.8%	87.8%-100%	NA	NA
dsDNAequivocal results Includedwith the test positive results	100%	100%	100%	NA	81.6%-100%	94.3%-100
equivocal results includedwith the test negative results	100%	98.2%	98.8%	86.6%-100%	NA	NA
SSA 60 kDaequivocal results includedwith the test positive results	100%	100%	100%	NA	88.3%-100%	93%-100%
TRIM 21(SSA 52kDa)equivocal results includedwith the test negative results	95.8%	100%	98.8%	86.7%-100%	NA	NA
equivocal results includedwith the test positive results	100%	98.2%	98.8%	86.6%-100%	NA	NA
equivocal results includedwith the test negative results	100%	98.5%	98.8%	88.2%-100%	NA	NA
SSBequivocal results includedwith the test positive results	100%	100%	100%	NA	83.2%-100%	94.1%-100
equivocal results includedwith the test negative results	100%	100%	100%	NA	81.6%-100%	94.3%-100%
Smequivocal results includedwith the test positive results	100%	100%	100%	NA	82.4%-100%	94.2%-100%
equivocal results includedwith the test negative results	100%	98.4%	98.8%	87.3%-100%	NA	NA
Sm/RNPequivocal results includedwith the test positive results	95.2%	98.3%	97.5%	85.8%-100%	NA	NA
equivocal results includedwith the test negative results	100%	96.9%	97.5%	86.8%-100%	NA	NA
Sc170equivocal results includedwith the test positive results	100%	100%	100%	NA	81.6%-100%	94.3%-100%
equivocal results includedwith the test negative results	100%	100%	100%	NA	72.3%-100%	94.8%-100%
Jo1equivocal results includedwith the test positive results	100%	100%	100%	NA	75.8%-100%	94.7%-100%
equivocal results Includedwith the test negative results	100%	98.6%	98.8%	90.2%-100%	NA	NA
CENP-Bequivocal results Includedwith the test positive results	100%	100%	100%	NA	67.6%-100%	94.9%-100%
equivocal results Includedwith the test negative results	100%	100%	100%	NA	61.0%-100%	95.1%-100%
Ribosomesequivocal results Includedwith the test positive results	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

-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 orIU/mL	8%	13%	6%	15%
30 to 400 AU/mL orIU/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 10Manual Use
		Pos	Neg	Total
MODIFIEDFIDIS™	Pos	16	1	17
CONNECTIVE10With 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 10Manual Use
		Pos	Neg	Total
MODIFIEDFIDIS™CONNECTIVE10With 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 10Manual Use
		Pos	Neg	Total
MODIFIEDFIDIS™CONNECTIVE10With CARIS™	Pos	16	1	17
	Neg	0	63	63
	Total	16	64	80
SS-A 60kDa		MODIFIED FIDIS™CONNECTIVE 10Manual Use
		Pos	Neg	Total
MODIFIEDFIDIS™CONNECTIVE10With 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-A 60kDa

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: 98.1% (53/54)
Overall agreement: 98.8% (79/80)

=> SS-B

SS-B		MODIFIED FIDIS™CONNECTIVE 10Manual Use
		Pos	Neg	Total
MODIFIEDFIDIS™CONNECTIVE10With 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 10Manual Use
		Pos	Neg	Total
MODIFIEDFIDIS™	Pos	20	0	20
CONNECTIVE10With 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 10Manual Use
	Pos	Neg	Total
MODIFIEDFIDIS™CONNECTIVE10With 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 10Manual Use
		Pos	Neg	Total
MODIFIEDFIDIST™	Pos	8	0	8
CONNECTIVE10With CARIST™	Neg	0	72	72
	Total	8	72	80
Jo-1		MODIFIED FIDIS™CONNECTIVE 10Manual Use
		Pos	Neg	Total
MODIFIEDFIDIS™CONNECTIVE10With 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 10Manual Use
		Pos	Neg	Total
MODIFIEDFIDIST™	Pos	6	0	6
CONNECTIVE10With 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 10Manual Use
		Pos	Neg	Total
MODIFIEDFIDISTMCONNECTIVE Neg10With 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 10Manual Use
		Pos	Neg	Total
MODIFIEDFIDIS™CONNECTIVE10With 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)

< Sm

Sm		MODIFIED FIDIS™CONNECTIVE 10Manual Use
MODIFIEDFIDIS™CONNECTIVE10With CARIS™	Pos	Pos	Neg	Total
	Neg	17	0	17
	Total	0	63	63
		17	63	80
		Pos	Neg	Total
MODIFIEDFIDISTM	Pos	29	0	29
CONNECTIVE	Neg	0	51	51
10With CARISTM	Total	29	51	80

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)

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

There were 3 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)

=> SS-B

SS-B		MODIFIED FIDIS™CONNECTIVE 10Manual Use
		Pos	Neg	Total
MODIFIEDFIDISTM	Pos	17	2	19
CONNECTIVE10With 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 10Manual Use
		Pos	Neg	Total
MODIFIEDFIDIS™	Pos	20	0	20
CONNECTIVE10With 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 10Manual Use
		Pos	Neg	Total
MODIFIEDFIDIS™CONNECTIVE10With 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 10Manual Use
		Pos	Neg	Total
MODIFIEDFIDIS™CONNECTIVE10With 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 10Manual Use
		Pos	Neg	Total
MODIFIEDFIDIS™CONNECTIVE10With 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
MODIFIEDFIDIS™CONNECTIVE10	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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AntigenicSpecificity		Positivepercentagreement	Negativepercentagreement	Overallagreement	EP12-AChap 9.2.2.	EP12-AChap 9.1.1.	EP12-AChap 9.1.1.
		proportion	proportion	proportion	95% CI	95% CIFor positiveagreement	95% CIFor negativeagreement
dsDNA	equivocal results includedwith the test negative results	100%	98.4%	98.8%	87.8%-100%	NA	NA
	equivocal results includedwith the test positive results	100%	100%	100%	NA	81.6%-100%	94.3%-100
SSA 60 kDa	equivocal results includedwith the test negative results	100%	98.1%	98.8%	86.5%-100%	NA	NA
	equivocal results includedwith the test positive results	100%	100%	100%	NA	88.3%-100%	93%-100%
TRIM 21(SSA 52kDa)	equivocal results includedwith the test negative results	100%	98.3%	98.8%	86.8%-100%	NA	NA
	equivocal results includedwith the test positive results	100%	100%	100%	NA	87.1%-100%	93.4%-100
SSB	equivocal results includedwith the test negative results	100%	100%	100%	NA	79.6%-100%	94.4%-100%
	equivocal results includedwith the test positive results	100%	96.8%	97.5%	86.5%-100%	NA	NA
Sm	equivocal results includedwith the test negative results	100%	98.4%	98.8%	87.8%-100%	NA	NA
	equivocal results includedwith the test positive results	100%	100%	100%	NA	81.6%-100%	94.3%-100
Sm/RNP	equivocal results includedwith the test negative results	100%	100%	100%	NA	83.9%-100%	94.0%-100%
	equivocal results includedwith the test positive results	95.2%	100%	98.8%	87%-100%	NA	NA
Sc170	equivocal results includedwith the test negative results	100%	96.9%	97.5%	86.8%-100%	NA	NA
	equivocal results includedwith the test positive results	100%	100%	100%	NA	81.6%-100%	94.3%-100%
Jo1	equivocal results includedwith the test negative results	100%	100%	100%	NA	72.3%-100%	94.8%-100%
	equivocal results includedwith the test positive results	100%	100%	100%	NA	75.8%-100%	94.7%-100%
CENP-B	equivocal results includedwith the test negative results	100%	100%	100%	NA	67.6%-100%	94.9%-100%
	equivocal results includedwith the test positive results	100%	98.6%	98.8%	89.8%-100%	NA	NA
Ribosomes	equivocal results includedwith the test negative results	100%	100%	100%	NA	61.0%-100%	95.1%-100%
	equivocal results includedwith 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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{17}------------------------------------------------

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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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{18}------------------------------------------------

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

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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

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Indication for Use

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

Device Name: .

FIDIS™ CONNECTIVE 10

Indication For Use:

(*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:

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

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).