The FIDIS™ VASCULITIS* kit is a semi-quantitative homogeneous fluorescent-based microparticle immunoassay using flow cytometry. The test system is used to simultaneously detect the presence of anti-neutrophil cytoplasmic antibodies (ANCA) directed against Myeloperoxidase (MPO), Serine Proteinase 3 (PR3) and antibodies directed against glomerular basement membrane (GBM) in human serum samples.

The results of the FIDIS™ VASCULITIS* test are to be used in conjunction with the clinical findings and the other laboratory tests to aid in the diagnosis of various primary systemic small blood vessel vasculitides and glomerular basement membrane disease.

Clinical utility:
The detection of ANCA is associated with primary systemic small blood vessel vasculitides: Wegener's granulomatosis, Churg Strauss syndromes, microscopic periarteritis and idiopathic crescentic glomerulonephritis; and the detection of anti-GBM antibodies is associated with Goodpasture's syndrome.

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

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

This kit is for In vitro diagnostic use.

Detection of the serologic markers for primary systemic small blood vessel vasculitides (ANCA) and for Goodpasture syndrome (GBM).

Device Description

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

FIDIS™ VASCULITIS* 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.

Three different fluorescently "colored" sets of microspheres are coated with antigens associated with various primary systemic small blood vessel vasculitides and glomerular basement membrane disease (MPO, PR3 and GBM). 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 four 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-MPO, anti-PR3 or anti-GBM 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™ VASCULITIS Assay kit, based on the provided document:

Acceptance Criteria and Device Performance:

The acceptance criteria for the FIDIS™ VASCULITIS Assay kit are derived from demonstrating substantial equivalence to a predicate device (K070458 FIDIS™ VASCULITIS system) and demonstrating comparable performance between manual and automated assay preparation. The performance metrics are Positive Percent Agreement (PPA), Negative Percent Agreement (NPA), and Overall Agreement (OA) for three specificities: MPO, PR3, and GBM. Precision (within-run and between-run %CV) was also assessed.

Table of Acceptance Criteria and Reported Device Performance:

Performance Metric	Specificity	Acceptance Criteria (from predicate comparison)	Reported Device Performance (Modified vs. Predicate - equivocal negative)	Reported Device Performance (Modified vs. Predicate - equivocal positive)	Reported Device Performance (CARIS™ vs. Manual - equivocal negative)	Reported Device Performance (CARIS™ vs. Manual - equivocal positive)
Positive Percent Agreement (PPA)	MPO	Not explicitly stated as a numerical threshold, but implied to be high agreement	100% (95/95)	95.4% (103/108)	95.2% (40/42)	100% (42/42)
	PR3	Not explicitly stated	98.9% (89/90)	100% (90/90)	97.6% (40/41)	100% (44/44)
	GBM	Not explicitly stated	100% (18/18)	100% (18/18)	100% (24/24)	100% (24/24)
Negative Percent Agreement (NPA)	MPO	Not explicitly stated	99.4% (184/185)	98.8% (170/172)	100% (64/64)	100% (64/64)
	PR3	Not explicitly stated	100% (190/190)	98.9% (188/190)	96.9% (63/65)	100% (62/62)
	GBM	Not explicitly stated	100% (262/262)	100% (262/262)	100% (82/82)	100% (82/82)
Overall Agreement (OA)	MPO	Not explicitly stated	99.6% (279/280)	97.5% (273/280)	98.1% (104/106)	100% (106/106)
	PR3	Not explicitly stated	99.6% (279/280)	99.3% (278/280)	97.2% (103/106)	100% (106/106)
	GBM	Not explicitly stated	100% (280/280)	100% (280/280)	100% (106/106)	100% (106/106)
Precision (%CV)	≤25 AU/mL	No explicit numerical acceptance criteria, but generally low %CV is desired	Within-run: 3-6%	N/A	Within-run: 5-8%	N/A
			Between-run: 4-11%	N/A	Between-run: 4-16%	N/A
	26-400 AU/mL	No explicit numerical acceptance criteria	Within-run: 2-9%	N/A	Within-run: 5-12%	N/A
			Between-run: 2-12%	N/A	Between-run: 2-12%	N/A

Study Proving Acceptance Criteria:

The document describes two primary studies to demonstrate that the device meets acceptance criteria:

Comparison study with predicate - Using Manual Pipetting: This study aimed to show substantial equivalence of the modified FIDIS™ VASCULITIS kit to the legally marketed predicate device (K070458).
Comparison studies (manual versus automated assay preparation steps) with CARIS™: This study aimed to demonstrate that the use of the CARIS™ system for automated sample preparation provided comparable results to manual preparation with the modified FIDIS™ VASCULITIS kit.

Detailed Study Information:

1. Sample sized used for the test set and the data provenance:

Comparison with predicate Study:
- Test set sample size: 280 samples.
- Data provenance: Not explicitly stated, but given that both the original and modified device are from "Biomedical Diagnostics S.A." in France, it is highly likely the data is from French or European sources. The study is retrospective as it compares the modified device against previously characterized samples with the predicate test.
CARIS™ Comparison Study:
- Test set sample size: 106 samples.
- Data provenance: Not explicitly stated, but also likely from French or European sources. The study seems to be prospective or concurrent comparison of two methods on the same set of samples.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

The document does not mention the use of experts or their qualifications for establishing ground truth. The "ground truth" for these studies is not clinical diagnosis by experts, but rather the results obtained from the predicate device (K070458 FIDIS™ VASCULITIS system) for the first study, and the modified FIDIS™ VASCULITIS with manual assay preparation for the second study. These methods are considered the reference for comparison.

3. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not applicable. There was no explicit adjudication described as the "ground truth" was established by the reference assays (predicate device or modified device with manual preparation). The document mentions how equivocal results were handled for calculation purposes (included with negative or positive results), but this is not an adjudication method for ground truth.

4. 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 device is an in vitro diagnostic (IVD) assay kit, not an AI-assisted diagnostic tool that involves human readers. The performance is based on agreement between two assay methods.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

The device itself (FIDIS™ VASCULITIS Assay kit) is essentially a standalone algorithm/test in the context of generating a quantitative result (AU/mL). The "standalone" performance is assessed by its agreement with the predicate device and the manual method. There is no human-in-the-loop directly interpreting raw data beyond what is typical for laboratory technicians running an assay and interpreting its results. The comparison studies effectively represent "standalone" performance against a defined reference.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

The "ground truth" in these studies is the results of a reference in-vitro diagnostic method.

For the predicate comparison study, the ground truth was the results obtained from the predicate device (K070458 FIDIS™ VASCULITIS).
For the CARIS™ comparison study, the ground truth was the results obtained from the modified FIDIS™ VASCULITIS with manual assay preparation.

7. The sample size for the training set:

Not applicable. This is an IVD assay kit, not an AI/machine learning model that typically requires a distinct training set. The performance is established through analytical validation studies (precision, method comparison).

8. How the ground truth for the training set was established:

Not applicable, as there is no training set in the AI/ML sense.

Summary

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1<1009.17

NOV 3 2010

Premarket Notification

510(k) Summary

FIDIST™ VASCULITIS Assay kit

Assigned 510(k) Number: K100917

Submitted by :

ಿಸ

Name:	Biomedical Diagnostics S.A (bmd)
Contact Person:	Christelle COURIVAUD
	Regulatory Affairs Manager
Address:	Actipole 25, 4-6 Bld de Beaubourg
	77435 Marne-La-Vallée Cedex 2
	FRANCE
Telephone:	33 (0)1 64 62 10 12
Fax:	33 (0)1 64 62 09 66
Establishment
Registration Number:	3003935253

US Agent correspondent:

P. Ann Hoppe, President Hoppe Regulatory Consultants LLC 103 South Cherry Street Falls Church VA 22046 703 532 1145 Office 404 441 0152 Mobile +3725 311 0011 Europe/Africa e-fax: 703 592 9024 E-mail: HoppeRegulatory@cs.com

2) Device Name

Trade/Proprietary Name :

FIDIS™ VASCULITIS Assay kit

Classification Names:

Test system, Antineutrophil Cytoplasmic Antibodies (ANCA) Devices, Measure, Antibodies to Glomerular Basement Membrane (GBM)

MX007 - MX507 - FIDIS™ VASCULITIS: Detection test for autoantibodies directed against Myeloperoxidase (MPO), Serine Proteinase 3 (PR3) and Glomerular Basement Membrane (GBM) in human serum

Common/Usual Name :

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

Page I

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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 horizontal line underneath. There are some black dots under the letters. The words "biomedical diagnostics" are written in a smaller font below the line.

Trade/Proprietary Name :	FIDIS™ Analyzer
Classification Name:	Instrumentation for Chemical Multiplex Systems

Trade/Proprietary Name :	CARISTTM System
Classification Name:	Device, Microtiter diluting/Dispensing

3) Legally marketed equivalent device

510K Number	Device Classification Name	Manufacturer Name
K070458	FIDISTM VASCULITIS	Biomedical DiagnosticsS.A.(bmd)

4) Device description

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

The four 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

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Image /page/2/Picture/0 description: The image shows the logo for Biomedical Diagnostics. The logo consists of the letters "bmd" in a stylized font, with the letters connected by a horizontal line. Below the letters is the text "biomedical diagnostics" in a smaller font. The logo is black and white.

<> 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

		MX007	MX507
96 wells microplate with filtering membrane and lid.	MP	1 plate	5 plates
Vial (A) of color-coded microsphere set of 3 sensitized by MPO (purified from human blood), PR3 (purified from human leucocytes) and GBM (purified from bovine tissues).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 x 115mL	10 x 115mL
Vial of calibrator titered in arbitrary units for the specificities to be measured.Ready to useEach titer is printed on the vial label	CAL	1 x 1.5mL	5 x 1.5mL
Vial of positive control concentrate. This control has a standard reactivity, which provides evidence of the proper reagents activity and proper assay performance.To be dilutedExpected values are printed on the vial label.	CONTROL +	1 x 250μL	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 x 100mL	5 x 100mL
Vial (D) of reconstitution buffer for the microsphere setReady to use	BUF MICROSPHERES	1 x 6mL	5 x 6mL
S.A au Capital de 2 755.46 EurosRCS Meaux: B 339 685 612	Registered Office :Actipole 25		Tel: 33 (0)1 64 62 10Fax : 33 (0)1 64 62 0

Siret: 339 685 612 00048-APE: 514N Nº TVA Intracommunautaire: FR 68 339 685 612

4-6 bd de Beaubourg 77435 Marne La Vallée cedex 2

2 રેણ Email: bmd@bmd-net.com Internet : www.bmd-net.com

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Image /page/3/Picture/0 description: The image shows a logo for "bmd biomedical diagnostics". The logo is in black and white. The letters "bmd" are in a stylized font, with the letters connected. Below the letters is the text "biomedical diagnostics" in a smaller font.

5) Intended use

FIDIS™ VASCULITIS Assay kit

Clinical utility:

The detection of ANCA is associated with primary systemic small blood vessel vasculitides: Wegener's granulomatosis, Churg Strauss syndromes, microscopic periarteritis and idiopathic crescentic glomerulonephritis; and the detection of anti-GBM antibodies is associated with Goodpasture's syndrome.

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

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

This kit is for In vitro diagnostic use.

Detection of the serologic markers for primary systemic small blood vessel vasculitides (ANCA) and for Goodpasture syndrome (GBM).

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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Image /page/4/Picture/0 description: The image shows the logo for Biomedical Diagnostics. The logo consists of the letters "bmd" in a stylized font, with a horizontal line underneath. There are two small droplets of liquid under the letters "b" and "d". Below the line, the words "biomedical diagnostics" are written in a smaller, sans-serif font.

6) Technological characteristics

The following table summarizes similarities and differences between the modified FIDIS™ VASCULITIS and the predicate device FIDIS™ VASCULITIS (K070458). Comparison with the predicate

		Predicate Device	Modified Device
		FIDIST™ VASCULITIS
		K070458	FIDIST™ VASCULITIS
	Intended use	Individual determination in humanserum, of IgG antibodies against:MPO, PR3 and GBM	Same
	Antigen	MPO: purified antigenPR3: purified antigenGBM: purified antigen	Same
CUT-OFF	Negative	<20 AU/mLfor the 3 specificities	Same
	Equivocal	20-25 AU/mLfor the 3 specificities	Same
	Positive	>25 AU/mLfor the 3 specificities	Same
	Beads	Vial of color-coded microsphere setready to use (6mL)	Vial of color-coded microsphere setLyophilized(Quantity sufficient to obtain 6mL afterreconstitution)
	Reconstitution buffer for themicrosphere set	No	Vial (D) of reconstitution buffer for the-microsphere setReady to use(6ml.)
	Sample dilution	Sample dilution buffer - (PBS-Tween)ready to use	Same
	Wash buffer	Washing buffer - (PBS-Tween)ready to use	Same
	Internal standard beads	Yes	Same
Assay configuration		1 "reagent-blank" well1 "negative control" well1 "positive control" well2 "calibrator" wells	Same
		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 cytometric	Same
	Number of readingmicrospheres per parameter	200	100
Reading time		60 seconds	90 seconds
	Microplate sealing films	6	No
	Sample delivery	Manual pipetting	Same
Automated sample delivery(option)		CARIST™ (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

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Image /page/5/Picture/0 description: The image shows a logo for "biomedical diagnostics". The logo consists of the letters "bmd" in a stylized font, with the letters connected at the top. There are some black shapes underneath the letters, and a horizontal line runs underneath the letters and shapes. The words "biomedical diagnostics" are written in a smaller font below the line.

7) Performance Characteristics

7.1. Precision study - Using Manual Pipetting

Precision of the assay was assessed using 6 samples for each of the three parameters (MPO, PR3, GBM). 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, 3 tests per run -

Table 1: Summary of FIDISTM VASCULITIS precision results using Manual Pipetting

	MPO, PR3 and GBM parameters
Sample range	Within-run		Between-run
	Minimal %CV	Maximal %CV	Minimal %CV	Maximal %CV
≤25 AU/mL	3%	6%	4%	11%
26 to 400 AU/mL	2%	9%	2%	12%

7.2. Comparison study with predicate - Using Manual Pipetting

bmd has compared the results obtained with modified FIDIS™ VASCULITIS versus the results obtained with predicate FIDIS™ VASCULITIS K070458.

The study was performed on 280 samples characterized with the predicate test and the result repartition is described below:

. 197 samples were positive for one or more parameters ANCA and/or GBM. Of the 197 samples: 192 are positive for one parameter, 3 are positive for two parameters and 2 are positive for all three parameters.
83 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

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Image /page/6/Picture/0 description: The image shows a logo with the letters "bmd" in a stylized font. Below the letters, there is a horizontal line, and below the line, the words "biomedical diagnostics" are written in a smaller, sans-serif font. The logo appears to be for a company in the biomedical diagnostics industry.

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

Table 2a: MPO performances

	MPO	PREDICATE FIDIS™VASCULITISK070458
MODIFIEDFIDIS™VASCULITIS		Positive	Negative	Total
	Positive	95	1	96
	Negative	0	184	184
	Total	95	185	280

results were considered to be negative. - Positive percent agreement: 100% (95/95)

There were 15 equivocal results with the . assay. For purposes of calculation, these

Negative percent agreement: 99.4% (184/185)
Overall agreement: 99.6% (279/280)

Table 3a: PR3 performances

PR3		PREDICATE FIDIS™VASCULITISK070458	Positive	Negative
MODIFIEDFIDIS™VASCULITIS	Positive	89	0	89
MODIFIEDFIDIS™VASCULITIS	Negative	1	190	191
	Total	90	190	280

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

Positive percent agreement: 98.9% (89/90)
Negative percent agreement: 100% (190/190)
Overall agreement: 99.6% (279/280)

Table 4a: GBM performances

GBM		PREDICATE FIDIS™VASCULITISK070458
		Positive	Negative	Total
MODIFIEDFIDIS™VASCULITIS	Positive	18	0	18
	Negative	0	262	262
	Total	18	262	280

There were 0 equivocal results with the assay.

Positive percent agreement: 100% (18/18)
Negative percent agreement: 100% l (262/262)
Overall agreement: 100% (280/280)

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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Image /page/7/Picture/0 description: The image shows the logo for Biomedical Diagnostics. The logo consists of the letters "bmd" in a stylized font, with a horizontal line underneath. Below the line, the words "biomedical diagnostics" are written in a smaller, sans-serif font. There are some black dots under the letters b and d.

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

⇒ MPO results

Table 2b: MPO performance
MPO		PREDICATE FIDIST™VASCULITISK070458
		Positive	Negative	Total
MODIFIED	Positive	103	2	105
FIDIST™VASCULITIS	Negative	5	170	175
	Total	108	172	280

There were 15 equivocal results with the assay. For purposes of calculation, these results were considered to be positive. - Positive percent agreement: 95.4%

(103/108)
Negative percent agreement: 98.8% (170/172)
Overall agreement: 97.5% (273/280)

→ PR3 results

Table 3b: PR3 performance
PR3		PREDICATE FIDIS™VASCULITISK070458
		Positive	Negative	Total
MODIFIEDFIDIS™VASCULITIS	Positive	90	2	92
	Negative	0	188	188
	Total	90	190	280

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

Positive percent agreement: 100% (90/90)
Negative percent agreement: 98.9% (188/190)
Overall agreement: 99.3% (278/280)

→ GBM results

Table 4b: GBM performance
GBM	PREDICATE FIDIS™VASCULITISK070458
	Positive	Negative	Total
MODIFIEDFIDIS™VASCULITIS	Positive	18	0	18
	Negative	0	262	262
	Total	18	262	280

There were 0 equivocal results with the assay.

Positive percent agreement: 100% (18/18)
Negative percent agreement: 100% (262/262)
Overall agreement: 100% (280/280)

ﻤﺴﻠﺴﻠﺴ

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

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Antigenic Specificity		MPO	PR3	GBM
Sample number		280	280	280
Positive percentagreement	equivocal results included with the testnegative results	100%	98.9%	100%
	equivocal results included with the testpositive results	95.4%	100%	100%
Negative percentagreement	equivocal results included with the testnegative results	99.4%	100%	100%
	equivocal results included with the testpositive results	98.8%	98.9%	100%
Overallagreement	equivocal results included with the testnegative results	99.6%	99.6%	100%
	equivocal results included with the testpositive results	97.5%	99.3%	100%
95%CI(EP12-AChap 9.2.2.)	equivocal results included with the testnegative results	93-100%	94-100%	N/A
	equivocal results included with the testpositive results	91-100%	93-100%	N/A
95%CIFor positiveagreement(EP12-AChap 9.1.1.)	equivocal results included with the testnegative results	N/A	N/A	82-100%
	equivocal results included with the testpositive results	N/A	N/A	82-100%
95%CIFor negativeagreement(EP12-AChap 9.1.1.)	equivocal results included with the testnegative results	N/A	N/A	99-100%
	equivocal results included with the testpositive results	N/A	N/A	99-100%

Table 5: Summary of performance agreement results

All of results show that FIDIS™ VASCULITIS system can be considered substantially equivalent to the predicate K070458 FIDISTM VASCULITIS system.

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: bmd(@bmd-net.com Internet : www.bmd-net.com

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Image /page/9/Picture/0 description: The image shows the logo for Biomedical Diagnostics. The logo consists of the letters "bmd" in a stylized font, with the letters connected and sitting above a horizontal line. Below the line, the words "biomedical diagnostics" are printed in a smaller, sans-serif font. There are some black blobs under the letters.

7.3.Performance data for modified FIDIS™ VASCULITIS with CARISTM (diluting/ dispensing Device)

Precision study a.

Internal study was conducted to evaluate the reproducibility of the use of CARISTM with modified FIDISTM VASCULITIS.

For within-run: 10 tests in a same run. -
For between-run: 5 runs, 3 tests per run. -

Table 6: Summary of CARISTM precision results

	MPO, PR3 and GBM parameters
Sample range	Within-run		Between-run
	Minimal %CV	Maximal %CV	Minimal %CV	Maximal %CV
≤ 25 AU/mL	5%	8%	4%	16%
26 to 400 AU/mL	5%	12%	2%	12%

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

bmd has compared the results obtained with modified FIDISTM VASCULITIS for manual or automated (with CARIS™).assay preparation steps.

The study was performed on 106 samples characterized with the modified FIDISTM VASCULITIS with manual assay preparation step. The result repartition is described below:

The result repartition is described below.

98 positive samples for one or more serotypes.

98 positive samples for one or more parameters ANCA and/or GBM. -Of the 91 samples, 94 are positive for one parameter, 2 are positive for two parameters and 2 are positive for all three parameters.
8 negative samples -

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

→ Table 7a: MPO performances

MPO		MODIFIED FIDIS™VASCULITISManual
		Positive	Negative	Total
MODIFIEDFIDIS™	Positive	40	0	40
VASCULITIS	Negative	2	64	66
WithCARISTM	Total	42	64	106

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

Positive percent agreement: 95.2% -(40/42)
. Negative percent agreement: 100% (64/64)
- Overall agreement: 98.1% (104/106)

Table 8a: PR3 performances

PR3		MODIFIED FIDIS™VASCULITISManual
		Positive	Negative	Total
MODIFIEDFIDIS™VASCULITISWithCARIS™	Positive	40	2	42
	Negative	1	63	64
	Total	41	65	106

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

Positive percent agreement: 97.6% -(40/41)
-Negative percent agreement: 96.9% (63/65)
- Overall agreement: 97.2% (103/106)

→ Table 9a: GBM performances

GBM	MODIFIED FIDIS™VASCULITISManual
	Positive	Negative	Total
MODIFIEDFIDIS™	Positive	24	0	24
VASCULITISWith CARISTM	Negative	0	82	82
	Total	24	82	106

There were 0 equivocal results with the assay.

Positive percent agreement: 100% i (24/24)
। Negative percent agreement: 100% (82/82)
Overall agreement: 100% (106/106) -

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

→ MPO results

Table 7b: MPO performance
	MODIFIED FIDIS™VASCULITISManual
MPO	Positive	Negative	Total
MODIFIEDFIDIS™VASCULITISWithCARIS™	Positive	42	0	42
	Negative	0	64	64
	Total	42	64	106

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

Positive percent agreement: 100% • (42/42)
Negative percent agreement: 100% ー (64/64)
-Overall agreement: 106% (106/106)

→ PR3 results

Table 8b: PR3 performance
PR3	MODIFIED FIDIS™VASCULITISManual
	Positive	Negative	Total
MODIFIEDFIDIS™VASCULITISWithCARIS™	Positive	44	0	44
	Negative	0	62	62
	Total	44	62	106

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

Positive percent agreement: 100% -(44/44)
Negative percent agreement: 100% . (62/62)
Overall agreement: 100% (106/106) -

⇒ GBM results

Table 9b: GBM performance
GBM		MODIFIED FIDIST™VASCULITISManual
		Positive	Negative	Total
MODIFIEDFIDIST™VASCULITISWithCARIST™	Positive	24	0	24
	Negative	0	82	82
	Total	24	82	106

There were 0 equivocal results with the assay.

Positive percent agreement: 100% ၊ (24/24)
Negative percent agreement: 100% -(82/82)
Overall agreement: 100% (106/106)

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	Antigenic Specificity	MPO	PR3	GBM
	Sample number	106	106	106
Positive percentagreement	equivocal results included with the testnegative results	95.2%	97.6%	100%
	equivocal results included with the testpositive results	100%	100%	100%
Negative percentagreement	equivocal results included with the testnegative results	100%	96.9%	100%
	equivocal results included with the testpositive results	100%	100%	100%
Overallagreement	equivocal results included with the testnegative results	98.1%	97.2%	100%
	equivocal results included with the testpositive results	100%	100%	100%
95%CI(EP12-AChap 9.2.2.)	equivocal results included with the testnegative results	87-100%	86-100%	N/A
	equivocal results included with the testpositive results	N/A	N/A	N/A
95%CIFor positiveagreement(EP12-AChap 9.1.1.)	equivocal results included with the testnegative results	N/A	N/A	86-100%
	equivocal results included with the testpositive results	92-100%	92-100%	86-100%
95%CIFor negativeagreement(EP12-AChap 9.1.1.)	equivocal results included with the testnegative results	N/A	N/A	99-100%
	equivocal results included with the testpositive results	94-100%	94-100%	96-100%

Table 10: Summary of performance agreements results obtained with CARIS™ versus manual

All of previous evaluations results indicate that manual and automated (with CARIS™) assay preparation steps are substantially equivalent.

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8) Conclusions

=> In conclusion, all supporting data demonstrate that the FIDIS™ VASCULITIS 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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Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993-0002

Biomedical Diagnostics (bmd) SA c/o Ms. Christelle Courivaud Regulatory Manager Actipole 25, 4-6 Bld de Beaubourg 77435 Marne-La-Vallee Cedex 2 France

NOV 0 3 2010

Re: K100917

Trade/Device Name: FIDIS™ VASCULITIS Assay Kit Regulation Number: 21CFR$866.5660 Regulation Name: Multiple autoantibodies immunological test system Regulatory Class: Class II Product Code: MOB, MVJ Dated: October 6. 2010 Received: October 7, 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21

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Page 2 - Ms Christelle Courivaud

CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

ia m chan

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

Enclosure

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Indication for Use

NOV 0 3 2010

510(k) Number (if known): K100917

Device Name:

FIDISTNI VASCULITIS

Indication For Use:

Clinical utility:

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

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

This kit is for In vitro Diagnostic Use.

Detection of the serologic markers for primary systemic small blood vessel vasculitides (ANCA) and for Goodpasture syndrome (GBM).

Prescription Use X (21 CFR Part 801 Subpart D)

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

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

And/Or

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

Marai M. Chen

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

Regulation Number and Section

§ 866.5660 Multiple autoantibodies immunological test system.

(a)
Identification. A multiple autoantibodies immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the autoantibodies (antibodies produced against the body's own tissues) in serum and other body fluids. Measurement of multiple autoantibodies aids in the diagnosis of autoimmune disorders (disease produced when the body's own tissues are injured by autoantibodies).(b)
Classification. Class II (performance standards).