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 test 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

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 kit includes a 96 wells microplate, vials of color-coded microsphere beads coupled with MPO, PR3, and GBM, plus internal standard beads, sample dilution buffer, calibrator, positive control, negative control, anti-human IgG coupled to phycoerythrin, washing buffer, package insert, microplate assay configuration worksheet, and microplate sealing films. The test is run on the FIDIS™ Instrument and MLX-BOOSTER Software and may be used with the CARIS™ system (diluting and dispensing device).

AI/ML Overview

Here's a summary of the acceptance criteria and study details for the FIDIS™ VASCULITIS assay, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document primarily focuses on demonstrating substantial equivalence to a predicate device (K053012 FIDIS™ VASCULITIS) and the equivalence of manual vs. automated assay preparation with the CARIS™ system. The "acceptance criteria" are therefore implicit in the comparison studies (e.g., high percentage agreement with the predicate device) and explicit in the precision studies.

Analytical Performance (Precision)

Sample Range	Acceptance Criteria for Within-run and Between-run (%CV)	MPO, PR3, and GBM Parameters (Within-run)	MPO, PR3, and GBM Parameters (Between-run)
Less than 10 AU/mL	Not calculated	Not calculated	Not calculated
10 to 19 AU/mL	≤20%	Minimal: 5.3%, Maximal: 11.3%	Minimal: 11.2%, Maximal: 19.6%
20 to 400 AU/mL	≤15%	Minimal: 2.3%, Maximal: 12.4%	Minimal: 5.4%, Maximal: 14.2%

Comparison Study with Predicate Device (K053012 FIDIS™ VASCULITIS)

The acceptance criteria for these sections are implied to be high agreement percentages indicating substantial equivalence.

Antigenic Specificity	Positive Percent Agreement (Reported)	Negative Percent Agreement (Reported)	Overall Agreement (Reported)
MPO	97.18%	100%	99.09%
PR3	95.92%	99.41%	98.63%
GBM	100%	100%	100%

Performance Data for Modified FIDIS™ VASCULITIS with CARIS™ (Precision)

Sample Range	Acceptance Criteria for Within-run and Between-run (%CV)	MPO, PR3, and GBM Parameters (Within-run)	MPO, PR3, and GBM Parameters (Between-run)
Less than 10 AU/mL	Not calculated	Not calculated	Not calculated
10 to 19 AU/mL	≤20%	Minimal: 4.9%, Maximal: 6.9%	Minimal: 6.9%, Maximal: 13.6%
20 to 400 AU/mL	≤15%	Minimal: 2.6%, Maximal: 10.8%	Minimal: 5.9%, Maximal: 11.7%

Comparison Studies (Manual vs. Automated Assay Preparation Steps with CARIS™)

The acceptance criteria for these sections are implied to be high agreement percentages indicating substantial equivalence.

Antigenic Specificity	Positive Percent Agreement (Reported)	Negative Percent Agreement (Reported)	Overall Agreement (Reported)
MPO	100%	97.59%	98.29%
PR3	100%	97.83%	98.29%
GBM	100%	100%	100%

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

Comparison Study with Predicate Device:
- Sample Size: 219 samples.
- Data Provenance: Not explicitly stated, but samples were "characterized with the predicate test." The origin (e.g., country, retrospective/prospective) is not provided.
Interfering Substances Study:
- Sample Size: 27 samples.
- Data Provenance: "obtained from a routine laboratory," suggesting retrospective clinical samples. Origin not specified.
Threshold values study:
- Sample Size: 37 samples from blood donors and 28 samples selected for potential biological interferences (total = 65 samples).
- Data Provenance: Not explicitly stated, likely clinical samples. Origin not specified.
CARIS™ Comparison Studies (Manual vs. Automated):
- Sample Size: 117 samples.
- Data Provenance: Not explicitly stated. The samples were "characterized with the modified FIDISTM VASCULITIS with manual assay preparation step." Origin not specified.

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

The document does not describe the use of human experts to establish ground truth for the test sets. For the comparison studies, the "ground truth" for the modified device was the results obtained from the predicate device (K053012 FIDIS™ VASCULITIS) or the manual preparation method for the CARIS™ comparison. The predicate device itself would have undergone its own validation studies to establish its accuracy. Similarly, for precision, the "ground truth" is the assay's own measurement, with reproducibility being the focus.

4. Adjudication Method for the Test Set

No adjudication method involving experts is described. In the comparison studies, equivocal results were consistently treated as negative for the purpose of calculating agreement percentages.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

This section is not applicable as the device is an in vitro diagnostic (IVD) assay for detecting autoantibodies, not an AI-assisted diagnostic imaging or interpretation tool designed to improve human reader performance. The device provides quantitative results, and the studies assess the analytical performance and agreement with a predicate device or different preparation methods.

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

The device itself (FIDIS™ VASCULITIS kit and FIDIS™ Analyzer/MLX-BOOSTER software) is a standalone system in the sense that it performs the measurement and provides results without human interpretive input beyond following the assay protocol. The studies presented are essentially standalone performance studies demonstrating the analytical performance (precision, linearity, interference, stability) of the assay system itself, and its agreement with a previously cleared device. The CARIS™ system is an optional automated sample preparation component, and its impact on the assay's performance is also assessed in a standalone manner (automated vs. manual).

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

The "ground truth" used in these studies is primarily:

Predicate Device Results: For the comparison study of the modified FIDIS™ VASCULITIS against its predicate (K053012), the results obtained from the predicate device served as the reference or "ground truth" for determining agreement.
Manual Assay Preparation Results: For the comparison study involving the CARIS™ system, the results obtained using manual assay preparation steps served as the reference for determining the agreement of the automated method.
Internal Assay Measurements: For analytical performance studies like precision, linearity, interfering substances, and stability, the "ground truth" is typically established by the inherent physical/chemical properties of the samples and the expected performance characteristics of the assay itself, often with reference to spiked samples or known concentrations.

There is no mention of expert consensus, pathology, or outcomes data being used directly to establish ground truth for these performance evaluations.

8. The Sample Size for the Training Set

The document does not explicitly describe a "training set" in the context of machine learning or AI models. This device is an IVD assay, not an AI algorithm that undergoes a training phase. The samples used for establishing analytical performance parameters (precision, linearity, interference, stability) and for comparison against the predicate are test samples used for validation, not for training a model.

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

As noted above, the concept of a "training set" and its associated ground truth establishment is not applicable to this in vitro diagnostic assay. The studies focus on validating the performance of a wet-lab assay and associated instrumentation.

Summary

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Image /page/0/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. Below the letters is a horizontal line, and below that is the text "biomedical diagnostics" in a smaller font. The letters "bmd" are in a bold, sans-serif font, and the letters are connected at the top.

Premarket Notification 510(k) Summary

Assigned 510(k) Number: K070458

DEC 2 1 2007

	1) Submitted by :
	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:

Hoppe Regulatory Consultants Ms P. Ann HOPPE 2335 Massey Lane Decatur GA 30033 USA Phone: 404 920 1847 E-mail: HoppeRegulatory@cs.com

2) Device Name

Trade/Proprietary Name :	FIDIS™ VASCULITIS Assay kit
Common/Usual Name :	MX007 - FIDIS™ VASCULITIS: Detection test forautoantibodies directed against Myeloperoxidase (MPO),Serine Proteinase 3 (PR3) and Glomerular BasementMembrane (GBM) in human serum
Classification Names:	Test system, Antineutrophil Cytoplasmic Antibodies (ANCA)Devices, Measure, Antibodies to Glomerular BasementMembrane (GBM)
Trade/Proprietary Name :	FIDIS™ Analyzer
Classification Name:	Instrumentation for Chemical Multiplex Systems
Trade/Proprietary Name :	CARIST™ System
Classification Name:	Device, Microtiter diluting/Dispensing

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3) Intended 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 test is for In vitro diagnostic use.

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

4) Materials supplied

1 x 96 wells microplate including a filtering membrane and a lid.	1 plate
1 vial (A) of 3 sets of color-coded microsphere beads coupled withMPO, PR3 and GBM*, plus 1 set of internal standard beads.Ready to use	1 x 6mL
1 vial (B) of sample dilution buffer (PBS-Tween) (white vial)Ready to use	2 x 115mL
1 vial of calibrator** titered for the specificities to be measured.Ready to useEach titer is printed on the vial label	1 x 1,5mL

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1 vial of positive control** concentrate. This control has a standardreactivity that provides evidence of the proper functioning ofreagents and correct assay performance.To be dilutedExpected values are printed on the vial label.	1 x 250 µL
1 vial of negative control** concentrate. To be diluted	1 x 250μL
1 vial of anti-human IgG coupled to phycoerythrinReady to use	1 x 12mL
1 vial (C) of washing buffer (PBS-Tween) (black vial)Ready to use	1 x 100mL
Package Insert	1
Microplate Assay Configuration Worksheet	1
Microplate sealing films	6

GBM antigen purified from type IV collagen.

** Calibrator and control titers are expressed in arbitrary units per mL (AU/mL).

5) Predicate Device

510K Number	Device Classification Name	Manufacturer Name
K053012	FIDISTM VASCULITIS	Biomedical DiagnosticsS.A.(bmd)

6) Comparison with the predicate

		Predicate DeviceFIDISTM VASCULITISK053012	Modified DeviceFIDISTM 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	<20 AU/mLfor the 3 specificities	Same
	Equivocal	20-25 AU/mLfor the 3 specificities	Same
	Positive	>25 AU/mLfor the 3 specificities	Same
	Material supplied	Microplate with caps	Microplate with sealing films (no change in function and provides flexible use)
	Sample dilution	PBS-Tween concentrated	Sample dilution buffer – same ingredients but ready to use
	Wash buffer	PBS-Tween concentrated	Washing buffer – same ingredients but ready to use

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	Predicate DeviceFIDIST™ VASCULITISK053012	Modified DeviceFIDIST™ VASCULITIS
Internal standard beads	No	Yes
Assay configuration	1 "reagent-blank" well1 "calibrator" well1 "negative control" well1 "positive control" well	1 "reagent-blank" well1 "negative control" well1 "positive control" well2 "calibrator" wells
	Diluted sample wells	Same
	A second calibrator well every 32 wellseries	No
Incubation time	2 x 30mn RT	Same
Assay protocol	Optional final wash step	Final wash step (not optional)
Software	MLX-Booster Version 1.35	MLX-Booster Version 2.2
Assay technology	Flow cytometric	Flow cytometric
Sample delivery	Manual pipetting	Same
Automated sample delivery(option)	CARIS™ (pipettor)	Same

7) Performance Characteristics

1. Analytical performance

a. Precision
Precision of the assay was assessed in 16 samples for antibodies to each of the three analytes (MPO, PR3, GBM) and 3 negative samples. Precision was determined by calculating the within-run (intra-assay) and the between run (interassay).
For within-run: 10 tests in a same run.
For between-run: 5 runs, 3 tests per run.

Samplerange	Acceptancecriteria forwithin-run andbetween-run	MPO, PR3 and GBM parametersWithin-run		Between-run
		Minimal %CV	Maximal %CV	Minimal %CV	Maximal %CV
Less than10 AU/mL	Not calulated	Not calculated	Not calculated	Not calculated	Not calculated
10 to 19AU/mL	%CV≤20%	5.3%	11.3%	11.2%	19.6%
20 to 400AU/mL	%CV≤15%	2.3%	12.4%	5.4%	14.2%

Table 1: Summary of FIDIS™ Vasculitis precision results

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b. Linearity/ assay reportable range

FIDIS™ VASCULITIS assay has been optimized to express the average binding capacity at the current dilution (1:200) by a flow cytometric reading determined as the median fluorescence value obtained from 200 microspheres per parameter.

Further dilution potentially gives rise to inaccurate results because the reaction conditions and the equilibrium of the immunological reaction may be modified.

c. Interfering Substances

The study was conducted by testing 27 MPO, PR3, GBM negative samples characterized as positive for various potential interferences obtained from a routine laboratory.

	Number of positive samples
	MPO	PR3	GBM
Cryoglobulinemia N=2	0	0	0
Complement N=8	0	0	0
IgG monoclonalimmunoglobulins N=2	0	0	0
IgM monoclonalimmunoglobulins N=3	0	0	0
Rheumatoid factor N=7	0	1	0
Citrated plasma N=3	0	0	0
Hemolyzed sera N=2	0	0	0

Table 2: Summary of Interfering Substance results

N: number of samples tested

d. Threshold values

Threshold values were estimated from the 2 selected populations:

. 37 samples from blood donors
I 28 samples selected for their potential biological interferences

The negative thresholds (20AU/mL) correspond to the 100% of negative MPO/GBM samples and 98.5% of negative PR3 samples for the populations studied.

Stability of the assay results after final wash step e.

This assay included 3 test series for 6 samples per analyte (MPO, PR3, GBM). Each series of tests was washed and read after different times:

-T= 0 hour: the first series of tests was read immediately after the final wash step.
। T= 4 hours: the second series of test was read after 4 hours of storage at room temperature away from direct sunlight.

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T=18 hours: the last series was read after 18 hours of storage at room temperature away from direct sunlight.

%CV acceptancecriteria	Parameter	Sample	Mean(AU/mL)	%CV
CV%<15%	MPO	Sample 1	19	14%
		Sample 2	32	6%
		Sample 3	45	4%
		Sample 4	92	4%
		Sample 5	156	12%
		Sample 6	260	8%
CV%<15%	PR3	Sample 7	23	11%
		Sample 8	29	3%
		Sample 9	50	3%
		Sample 10	106	10%
		Sample 11	231	8%
		Sample 12	834	6%
CV%<15%	GBM	Sample 13	78	5%
		Sample 14	79	5%
		Sample 15	108	6%
		Sample 16	129	5%
		Sample 17	150	7%
		Sample 18	213	5%

Table 3: Summary of Stability of the assay results after final wash step

Based on the common laboratories practices, the time range recommended is "one hour for a plate when stored at room temperature away from direct sunlight".

2. Comparison study with predicate

ﺖ

bmd has compared the results obtained with modified FIDIS™ VASCULITIS versus the results obtained with predicate FIDIS™ VASCULITIS K053012.

The study was performed on 219 samples characterized with the predicate test and the result repartition is described below:

135 samples were positive for one or more parameters ANCA and/or - GBM.
84 negative samples including some samples evaluated for their potential biological interferences.

All equivocal samples with predicate and FIDIS™ VASCULITIS tests are considered negative for the comparison and the evaluation studies.

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> Table 4: MPO performances

		PREDICATE FIDIS™VASCULITISK053012
			Positive Negative	Total
MODIFIEDFIDIS™VASCULITIS	Positive	69	0	રેત્વે છે. આ ગામમાં પ્રાથમિક શાળા, આંગણવાડી તેમ જ દૂધની ડેરી જેવી સવલતો પ્રાપ્ય થયેલી છે. આ ગામનાં લોકોનો મુખ્ય વ્યવસાય ખેતી, ખેતમજૂરી તેમ જ પશુપાલન છે. આ ગામમાં મુખ્યત્વે આ
	Negative	2	148	1 20
	Total	71	148	219

→ Table 5: PR3 performances

		PREDICATE FIDIS™VASCULITISK053012
		Positive	Negative	Total
MODIFIEDFIDIST™VASCULITIS	Positive	47	1	48
	Negative	2	169	171
	Total	49	170	219

→ Table 6: GBM performances

	PREDICATE FIDIS™VASCULITISK053012
	Positive	Negative	Total
MODIFIEDFIDIS™VASCULITIS	Positive	25	0	25
	Negative	0	194	194
	Total	25	194	219

There were 7 equivocal results with assay. the For purposes of calculation. these results were considered as negative.

Positive percent agreement: -97.18% (69/71)
-Negative percent agreement: 100% (148/148)
-Overall agreement: 99.09% (217/219)

There were 11 equivocal results with assay. the For purposes of calculation, these results were considered as negative.

Positive percent agreement: ・ 95.92% (47/49)
-Negative percent agreement: 99.41% (169/170)
Overall agreement: 98.63% (216/219)

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

-Positive percent agreement: 100% (25/25)
. Negative percent agreement: 100% (194/194)
-Overali agreement: 100% (219/219)

Table 7: Summary of performance agreement results

AntigenicSpecificity	Samplenumber	Positivepercentagreement	Negativepercentagreement	Overallagreement
MPO	219	97.18%	100%	99.09%
PR3	219	95.92%	99.41%	98.63%
GBM	219	100%	100%	100%

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In addition to the analysis above, the 95% one-sided lower confidence limit in percent of proportion agreement (95% LCL (%) was calculated using the Exact Binomial Test for proportions to determine how low this proportion could be with a 95% confidence.

Table 7a: Summary of performance agreements results - 95% LCL (%)

AntigenicSpecificity	N	Positive Agreement				Negative Agreement				Overall Agreement
		N₁	R₁	P₁ (%)	95% LCL (%)	N₂	R₂	P₂ (%)	95% LCL (%)	N	R	P (%)	95% LCL (%)
MPO	219	71	69	97.18	91.40	148	148	100.00	98.00	219	217	99.09	97.15
PR3	219	49	47	95.92	87.70	170	169	99.41	97.24	219	216	98.63	96.50
GBM	219	25	25	100.00	88.71	194	194	100.00	98.47	219	219	100.00	98.64

N1 = No. of positives;R1 = No. of positive agreements; P1 = R1/N1

N2 = No. of negatives; R2 = No. of negative agreements; P2 = R2/N2

N = N; + N2; R = R1 + R2; P = R/N

All of results show that FIDISTM VASCULITIS system can be considered substantially equivalent to the predicate K053012 FIDISTM VASCULITIS system.

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

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

Precision of the assay was assessed in 16 samples for antibodies to each of the three parameters (MPO, PR3, GBM) and 3 negative samples. Precision was determined by calculating the within-run (intra-assay) and the between-run (interassay).

Precision was determined by calculating the within-run (intra-assay) and the between-run (inter-assay).

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

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Sample range	Acceptancecriteria forwithin-runand between-run	Within-runminimal CV%for MPO, PR3and GBMparameters	Within-runmaximalCV% forMPO, PR3and GBMparameters	Between-runminimal CV%for MPO, PR3and GBMparameters	Between-runmaximalCV% forMPO, PR3and GBMparameters
Less than10AU/mL	Not calculated	Not calculated	Not calculated	Not calculated	Not calculated
10 to 19AU/mL	CV=20%	4.9%	6.9%	6.9%	13.6%
20 to 400AU/mL	CV=15%	2.6%	10.8%	5.9%	11.7%

Table 8: Summary of CARIS™ precision results

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

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

The study was performed on 117 samples characterized with the modified FIDISTM VASCULITIS with manual assay preparation step.

The result repartition is described below:

75 positive samples for one or more parameters ANCA and/or GBM. –
42 negative samples including some samples evaluated for their – potential biological interferences.

All equivocal samples are considered negative for the comparison and the evaluation studies.

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∞ Table 9: MPO performances

MPO		MODIFIED FIDIS™VASCULITISManual
		Positive	Negative	Total
MODIFIEDFIDIS™VASCULITISWith CARIS	Positive	34	2	36
	Negative	0	81	81
	Total	34	83	117

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

Positive percent agreement: 100% ー (34/34)
Negative percent agreement: -97.59% (81/83)
-Overall agreement: 98.29% (115/117)

→ Table 10: PR3 performances

	PR3	MODIFIED FIDIS™VASCULITISManual
		Positive	Negative	Total
MODIFIEDFIDIS™VASCULITISWith CARIS	Positive	25	2	27
	Negative	0	90	90
	Total	25	92	117

→ Table 11: GBM performances

	GBM	MODIFIED FIDIS™VASCULITISManual	Positive	Negative
MODIFIEDFIDIS™VASCULITISWith CARIS	Positive	23	0	23
	Negative	0	94	94
	Total	23	94	117

assay. For purposes of calculation, these results were considered as negative. Positive percent agreement: 100% -

There were 6 equivocal results with the

· (25/25)
Negative percent agreement: । 97.83% (90/92)
-Overall agreement: 98.29% (115/117)

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

Positive percent agreement: 100% י (23/23)
Negative percent agreement: 100% । (94/94)
- Overall agreement: 100% (117/117)

Table 12: Summary of performance agreements results obtained with CARIS™ versus manual

ﺘ

AntigenicSpecificity	Samplenumber	Positivepercentagreement	Negativepercentagreement	Overallagreement
		proportion	proportion	proportion
MPO	117	100%	97.59%	98.29%
PR3	117	100%	97.83%	98.29%
GBM	117	100%	100%	100%

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Table 12a: Summary of performance agreements results obtained with CARIS™ versus manual -- 95% LCL (%)

AntigenicSpecificity	N	Positive Agreement				Negative Agreement				Overall Agreement
		N₁	R₁	P₁ (%)	95% LCL (%)	N₂	R₂	P₂ (%)	95% LCL (%)	N	R	P (%)	95% LCL (%)
MPO	117	34	34	100.00	91.57	83	81	97.59	92.61	117	115	98.29	94.72
PR3	117	25	25	100.00	88.71	92	90	97.83	93.31	117	115	98.29	94.72
GBM	117	23	23	100.00	87.79	94	94	100.00	96.86	117	117	100.00	97.47

N1 = No. of positives; R1 = No. of positive agreements; P1 = R1/N1

N2 = No. of negatives; N = N1 + N2; R = R1 + R2; P = R/N

All of previous evaluation results indicate that manual and automated (with CARISTM) assay preparation steps are substantially equivalent.

8) Conclusions

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

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/11/Picture/1 description: The image shows the logo for the Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES (USA)" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, symbolizing the department's mission to protect and promote the health and well-being of the nation.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

DEC 2 1 2007

Biomedical Diagnostics S.A. (BMD) c/o Ms. Christelle Courivaud Regulatory Affairs Manager Actipole 25, 4-6 Bld de Beaubourg 77435 Marne La Vallée cedex 2 France

Re: K070458

Trade/Device Name: FIDIS™ VASCULITIS* Assay Regulation Number: 21 CFR 866.5660 Regulation Name: Multiple autoantibodies immunological test system Regulatory Class: Class II Product Code: MOB, MVJ Dated: November 27, 2007 Received: November 30, 2007

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

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to

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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 information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (240) 276-0450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Robert Barton

Robert L. Becker, Jr., M.D., 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

510(k) Number (if known): K070458

Device Name:

FIDIS™ 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 test is for In vitro Diagnostic Use.

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

X : Prescription Use (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 (OIVD)

Maria M Chan

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety 510K 2070958

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).