K Number

Device Name

FIDIS VASCULITIS ASSAY KIT AND ANALYZER AND CARIS SYSTEM

Manufacturer

BIOMEDICAL DIAGNOSTICS (BMD) SA

Date Cleared

2010-11-03

(215 days)

Product Code

MOB MVJ

Regulation Number

866.5660

Intended Use

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.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K070458

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The description focuses on the immunoassay technology, flow cytometry, and standard data processing for quantification and calibration. There is no mention of AI or ML algorithms being used for analysis, interpretation, or decision support.

Therapeutic

No
The device is an in vitro diagnostic test used to detect specific antibodies in human serum samples to aid in the diagnosis of certain diseases, not to treat them.

Diagnostic

Yes
The product is explicitly stated as an "In vitro diagnostic use" kit, and its purpose is to "aid in the diagnosis of various primary systemic small blood vessel vasculitides and glomerular basement membrane disease" by detecting specific antibodies in human serum samples.

SaMD (Software as a Medical Device)

The device is a kit that includes physical components (microspheres, reagents, microplate) and is designed to be run on specific hardware (FIDIS™ Instrument and potentially the CARIS™ system), in addition to the MLX-BOOSTER Software. It is not solely software.

IVD (In Vitro Diagnostic)

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

The document explicitly states: "This kit is for In vitro diagnostic use."

Furthermore, the intended use describes the device as a "semi-quantitative homogeneous fluorescent-based microparticle immunoassay using flow cytometry" used to detect antibodies in "human serum samples" to "aid in the diagnosis of various primary systemic small blood vessel vasculitides and glomerular basement membrane disease." This aligns with the definition of an in vitro diagnostic device, which is used to examine specimens from the human body to provide information for diagnosis, monitoring, or screening.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The FIDISTM 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 FIDISTM 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.

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

FIDISTM VASCULITIS* kit may be used with the CARISTM 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).

Product codes (comma separated list FDA assigned to the subject device)

MOB, MVJ

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.

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)

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

Comparison study with predicate - Using Manual Pipetting
The study was performed on 280 samples characterized with the predicate test.

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.

Performance data for modified FIDIS™ VASCULITIS with CARISTM (diluting/ dispensing Device)
Precision study
Internal study was conducted to evaluate the reproducibility of the use of CARISTM with modified FIDISTM VASCULITIS. 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.

Comparison studies (manual versus automated assay preparation steps)
The study was performed on 106 samples characterized with the modified FIDISTM VASCULITIS with manual assay preparation step.

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.

All of results show that FIDIS™ VASCULITIS system can be considered substantially equivalent to the predicate K070458 FIDISTM VASCULITIS system.
All of previous evaluations results indicate that manual and automated (with CARIS™) assay preparation steps are substantially equivalent.

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

MPO performances (equivocal results considered negative):

Positive percent agreement: 100% (95/95)
Negative percent agreement: 99.4% (184/185)
Overall agreement: 99.6% (279/280)

PR3 performances (equivocal results considered negative):

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

GBM performances (equivocal results considered negative):

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

MPO performances (equivocal results considered positive):

Positive percent agreement: 95.4% (103/108)
Negative percent agreement: 98.8% (170/172)
Overall agreement: 97.5% (273/280)

PR3 performances (equivocal results considered positive):

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

GBM performances (equivocal results considered positive):

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

MPO performances (manual vs. CARISTM, equivocal results considered negative):

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

PR3 performances (manual vs. CARIS TM, equivocal results considered negative):

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

GBM performances (manual vs. CARIS TM, equivocal results considered negative):

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

MPO performances (manual vs. CARIS TM, equivocal results considered positive):

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

PR3 performances (manual vs. CARIS TM, equivocal results considered positive):

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

GBM performances (manual vs. CARIS TM, equivocal results considered positive):

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

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K070458

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

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).

Summary

1 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.

<> 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 use
Each 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 diluted
Expected values are printed on the vial label.	CONTROL +	1 x 250μL	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 x 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	Registered Office :
Actipole 25		Tel: 33 (0)1 64 62 10
Fax : 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

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

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).

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

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 human
serum, of IgG antibodies against:
MPO, PR3 and GBM	Same
	Antigen	MPO: purified antigen
PR3: purified antigen
GBM: purified antigen	Same
CUT-OFF	Negative	25 AU/mL
for the 3 specificities	Same
	Beads	Vial of color-coded microsphere set
ready to use (6mL)	Vial of color-coded microsphere set
Lyophilized
(Quantity sufficient to obtain 6mL after
reconstitution)
	Reconstitution buffer for the
microsphere set	No	Vial (D) of reconstitution buffer for the-
microsphere set
Ready 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" well
1 "negative control" well
1 "positive control" well
2 "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 reading
microspheres 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

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

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™
VASCULITIS
K070458 | | |
|----------------------------------|----------|-------------------------------------------|----------|-------|
| MODIFIED
FIDIS™
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™
VASCULITIS
K070458 | Positive | Negative | Total |
|----------------------------------|----------|-------------------------------------------|----------|----------|-------|
| MODIFIED
FIDIS™
VASCULITIS | Positive | 89 | 0 | 89 | |
| MODIFIED
FIDIS™
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™
VASCULITIS
K070458 | | |
|----------------------------------|----------|-------------------------------------------|----------|-------|
| | | Positive | Negative | Total |
| MODIFIED
FIDIS™
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

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™
VASCULITIS
K070458
		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™
VASCULITIS
K070458
		Positive	Negative	Total
MODIFIED
FIDIS™
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™
VASCULITIS
K070458
	Positive	Negative	Total
MODIFIED
FIDIS™
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

Image /page/8/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 three small, dark shapes resembling water droplets. Underneath the line, the words "biomedical diagnostics" are printed in a smaller, sans-serif font.

Antigenic Specificity		MPO	PR3	GBM
Sample number		280	280	280
Positive percent
agreement	equivocal results included with the test
negative results	100%	98.9%	100%
	equivocal results included with the test
positive results	95.4%	100%	100%
Negative percent
agreement	equivocal results included with the test
negative results	99.4%	100%	100%
	equivocal results included with the test
positive results	98.8%	98.9%	100%
Overall
agreement	equivocal results included with the test
negative results	99.6%	99.6%	100%
	equivocal results included with the test
positive results	97.5%	99.3%	100%
95%CI
(EP12-A
Chap 9.2.2.)	equivocal results included with the test
negative results	93-100%	94-100%	N/A
	equivocal results included with the test
positive results	91-100%	93-100%	N/A
95%CI
For positive
agreement
(EP12-A
Chap 9.1.1.)	equivocal results included with the test
negative results	N/A	N/A	82-100%
	equivocal results included with the test
positive results	N/A	N/A	82-100%
95%CI
For negative
agreement
(EP12-A
Chap 9.1.1.)	equivocal results included with the test
negative results	N/A	N/A	99-100%
	equivocal results included with the test
positive 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

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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™
VASCULITIS
Manual | | |
|--------------------|----------|-----------------------------------------|----------|-------|
| | | Positive | Negative | Total |
| MODIFIED
FIDIS™ | Positive | 40 | 0 | 40 |
| VASCULITIS | Negative | 2 | 64 | 66 |
| With
CARISTM | 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™
VASCULITIS
Manual | | |
|----------------------------------------------------|----------|-----------------------------------------|----------|-------|
| | | Positive | Negative | Total |
| MODIFIED
FIDIS™
VASCULITIS
With
CARIS™ | 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™
VASCULITIS
Manual | | | |
|----------------------------|-----------------------------------------|----------|-------|-----|
| | Positive | Negative | Total | |
| MODIFIED
FIDIS™ | Positive | 24 | 0 | 24 |
| VASCULITIS
With 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™
VASCULITIS
Manual
MPO	Positive	Negative	Total
MODIFIED
FIDIS™
VASCULITIS
With
CARIS™	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™
VASCULITIS
Manual
	Positive	Negative	Total
MODIFIED
FIDIS™
VASCULITIS
With
CARIS™	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™
VASCULITIS
Manual
		Positive	Negative	Total
MODIFIED
FIDIST™
VASCULITIS
With
CARIST™	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 percent
agreement	equivocal results included with the test
negative results	95.2%	97.6%	100%
	equivocal results included with the test
positive results	100%	100%	100%
Negative percent
agreement	equivocal results included with the test
negative results	100%	96.9%	100%
	equivocal results included with the test
positive results	100%	100%	100%
Overall
agreement	equivocal results included with the test
negative results	98.1%	97.2%	100%
	equivocal results included with the test
positive results	100%	100%	100%
95%CI
(EP12-A
Chap 9.2.2.)	equivocal results included with the test
negative results	87-100%	86-100%	N/A
	equivocal results included with the test
positive results	N/A	N/A	N/A
95%CI
For positive
agreement
(EP12-A
Chap 9.1.1.)	equivocal results included with the test
negative results	N/A	N/A	86-100%
	equivocal results included with the test
positive results	92-100%	92-100%	86-100%
95%CI
For negative
agreement
(EP12-A
Chap 9.1.1.)	equivocal results included with the test
negative results	N/A	N/A	99-100%
	equivocal results included with the test
positive 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

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

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