The BioArray Solutions ENA IgG BeadChip™ Test System is intended for use in testing human serum for the presence of human IgG class antibodies to six extractable nuclear antigens, SSA, SSB, Sm, Sm/RNP, Scl-70, and Jo-1. The presence of these autoantibodies can be used in conjunction with clinical findings and other laboratory tests to aid in the diagnosis of systemic lupus erythematosus, Sjögren's syndrome, scleroderma and myositis. This ENA IgG BeadChip is for use with Array Imaging System 400 (AIS400). This test is for in vitro diagnostic use.

Device Description

The ENA IqG BeadChip™ Test System is a randomly encoded microarray-based immunoassay for antibodies to extractable nuclear antigens. The device is designed to detect IgG class antibodies in human serum to six extractable nuclear antigens: SSA, SSB, Sm, RNP/Sm, Jo-1, and SCL-70. Each antigen is covalently immobilized to a spectrally distinguishable bead type. A and of bead types is constructed by mixing all of the bead types of interest including antigen beads, positive control beads, negative control beads, and system control beads. The bead mixture is immobilized as a BeadChip™ microarray on a silicon chip allowing for the simultaneous detection of the auto-antibodies of interest by the AIS 400.

AI/ML Overview

Here's an analysis of the acceptance criteria and study details from the provided 510(k) summary:

Acceptance Criteria and Device Performance

The device's performance is primarily assessed through a comparison with a predicate device (ENA IgG ImmuStrip™ Test System). The acceptance criteria are implicitly defined by the reported "Percentage Positive Agreement" and "Percentage Negative Agreement" with the predicate device for each antigen.

Table of Acceptance Criteria and Reported Device Performance

Antigen	Acceptance Criteria (Implied)	Reported Device Performance - % Positive Agreement	Reported Device Performance - % Negative Agreement	Reported Device Performance - % Total Agreement
SSA	High agreement (e.g., >90%)	95.9%	94.1%	94.5%
SSB	High agreement (e.g., >90%)	100.0%	96.1%	96.4%
Sm	High agreement (e.g., >90%)	98.0%	94.0%	94.9%
RNP/Sm	High agreement (e.g., >90%)	100.0%	91.7%	93.6%
Jo-1	High agreement (e.g., >90%)	100.0%	99.5%	99.6%
SCL-70	High agreement (e.g., >90%)	91.2%	98.9%	97.7%

Note: The specific numerical acceptance criteria (e.g., "must be >90%") are not explicitly stated in the document. They are inferred from the reported high agreement percentages, indicating that the device aims to closely match the predicate's results.

Study Details

Sample size used for the test set and the data provenance:
- Sample Size (Method Comparison Study): 229 samples were used for the method comparison study against the predicate device for each antigen. However, the agreement tables show varying "sub-total" numbers for analysis depending on the antigen due to "EQU" (equivocal) or "ND" (not determined) results. For example, for SSA, the total included in the agreement calculation was 218.
- Sample Size (Site-to-Site Reproducibility): 176 samples (52 normal, ~25 positive for each antigen) were provided to three testing sites. A total of 192 samples were run at each site, with 181 being included in the final analysis after exclusions.
- Data Provenance: Not explicitly stated but inferred to be clinical human serum samples. The document does not specify countries of origin. The studies appear to be prospective, as they involve testing samples for performance evaluation.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- The primary "ground truth" used for the method comparison study is the result obtained from the predicate device, the ENA IgG ImmuStrip™ Test System. The predicate device itself would have undergone its own validation studies.
- For the reproducibility and cutoff determination studies, clinical samples (pooled positive, pooled negative, normal samples, and disease positive samples) were used. These samples would have had a pre-established status (e.g., "positive for anti-SSA") which would serve as the ground truth. The section does not specify the number or qualifications of experts involved in establishing the initial status of these samples.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- The document describes a comparison against a predicate device rather than expert consensus adjudication for establishing ground truth for the method comparison study. The predicate device's result is taken as the reference.
- For the site-to-site reproducibility, "randomly encoded" samples were distributed, and agreement between the sites was assessed. No explicit adjudication method for discrepant results between sites is mentioned, beyond excluding samples due to "specimen control failure" or "sample preparation error."
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:
- No, an MRMC comparative effectiveness study was not done. This device is an in vitro diagnostic immunoassay system, not an AI-assisted diagnostic tool requiring human reader interpretation in the context of MRMC studies. The detection method is fluorometric and analyzed by a program, not directly by human readers.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Yes, a standalone performance study was done. The device itself, consisting of the ENA IgG BeadChip™ and the Array Imaging System 400 (AIS 400) with its ENA Analysis program, generates the test results. The method comparison study and reproducibility studies assess the performance of this system independently in generating results comparable to the predicate device and in achieving consistent results.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The primary ground truth for the method comparison study is the results from the legally marketed predicate device (ENA IgG ImmuStrip™ Test System).
- For reproducibility and cutoff determination, the ground truth for "positive" and "negative" samples (e.g., pooled positive sample, pooled normal serum sample, disease positive samples, normal samples) would likely be based on clinical diagnosis and/or established laboratory characterization of these samples.
The sample size for the training set:
- The submission does not explicitly describe a "training set" in the context of a machine learning or AI model development. This device is an immunoassay system.
- However, for cutoff determination, 130 normal samples were used to establish the normal range and positive cutoff values for each antigen. This could be considered analogous to a reference or normalization set rather than a training set for an algorithm in the AI sense.
How the ground truth for the training set was established:
- As there isn't a "training set" in the AI sense, the establishment of ground truth for method comparison relies on the predicate device's results.
- For the cutoff determination, the ground truth for the 130 normal samples was that they were from "healthy, asymptomatic human subjects." This is established through clinical criteria and screening for apparent health.

Summary

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510(k) SUMMARY

MAY 3 1 2005

"This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92."

THE ASSIGNED 510(K) NUMBER: K043067

SUBMITTED BY:	BioArray Solutions, Ltd.35 Technology Drive, Suite 100Warren, NJ 07059(908) 226-8200 (voice), (908) 226-0800 (fax)
CONTACT PERSON:	Kevin WyckoffQuality Assurance & Regulatory Affairs, Manager
Extension:	215
Email:	kwyckoff@bioarrays.com
DATE OF PREPARATION:	April 4, 2005
DEVICE NAME:	ENA IgG BeadChip™ Test System on the Array ImagingSystem (AIS 400)
CLASSIFICATION NAME:	Antinuclear antibody immunological test system(21 CFR 866.5100)
PREDICATE DEVICE:	ENA IgG ImmuStrip™ Test SystemDistributed by SLR Research CorporationCleared on April 8, 1995 under document number K964787by Mardx Diagnostics.

INTENDED USE

DEVICE DESCRIPTION

BioArray Solutions, Ltd.

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The ENA IgG BeadChip™ Test System kit will contain adequate reagents for 96 assays.

Patient samples are diluted prior to incubation with the BeadChip microarray. If ENA specific antibodies are present in the sample, they will bind to the immobilized antigen on one or more bead types. After washing the unbound serum from the BeadChip, Alexa-Fluor 647 conjugated goat anti-human IgG is added to the BeadChip and briefly incubated. After removing unbound detection conjugate, the BeadChip is imaged with the Array Imaging System 400 (AIS 400) to measure the fluorescent signal associated with the conjugate bound on individual beads. The average signal intensity, coefficient of variance of the intensities, and the number of beads measured for each type is determined and reported. The ENA Analysis program imports the instrument results, assesses the validity of the internal controls, and generates test results.

CHARACTERISTIC COMPARISON TO PREDICATE DEVICE

This ENA IgG BeadChip™ Test System is substantially equivalent in principle and clinical performance to the currently marketed ENA IgG ImmuStrip™ Test System marketed by SLR Research for the detection of extractable antinuclear antibodies. Similarities and differences between the procedures and ENA IgG test kits are described in Table 1.

DEVICE	PREDICATE
	A. Similarities
Intended Use. The BioArray Solutions ENABeadChip™ is intended for use in testinghuman serum for the presence of human IgGclass antibody to extractable nuclear antigens(ENA): SSA, SSB, Sm, Sm/RNP, Scl-70, andJo-1, as an aid in the diagnosis of autoimmunediseases, such as systemic lupuserythematosus, Sjogren's syndrome,sclerodema, and myositis. This test is for invitro diagnostic use.	The SLR ENA IgG Immustrip™ Test Systemis intended for use in testing human serumfor the presence of human IgG to extractablenuclear antigens, as an aid in the diagnosisof autoimmune disease, such as systemiclupus erthematosus, Sjögren's syndrome,sclerodema, and myositis.
Assay type - ImmunoassayAntigens - SSA, SSB, Sm, Sm/RNP, Scl-70,Jo-1Reporter conjugate - Alexa Fluor 647Assay Format - QualitativeSample Type - Serum	ImmunoassaySSA, SSB, Sm, Sm/RNP, Scl-70, Jo-1Alkaline PhosphataseQualitativeSerum
	B. Differences
Substrate - MicroparticleIncubation Time - 30/15 minutesMethod of Detection - Fluorometer	Strip30/30/15 minutesVisual

Table 1 - Comparison with Predicate

NON-CLINICAL PERFORMANCE DATA.

Non-clinical performance data has been submitted to address the following aspects: Performance comparison study to predicate device

Reproducibility study: over-time, operator-to-operator, and site-to-site comparison. Normal range and cutoff determination and analytical sensitivity. Cross-reacting and interference substances

Expiry date is two weeks from date of manufacture.

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SUMMARY OF PERFORMANCE DATA AND CONCLUSION.

A summary of the method comparison study results is listed in Table 2. The data submitted in this 510(K) Premarket Notification supports the finding that this product is substantially this o ro(r) i remainer rotheansed use, assay principle, and safety features to the legally equiraliant with rooped to the the entere, we believe that this device meets the requirement for a "Substantial Equivalence" decision in accordance with the 510(k) guidelines.

Predicate/BeadChip	POS/POS	NEG/NEG	POS/NEG	NEG/POS	EQU/ND	Total	% PostiveAgreement	% NegativeAgreement
SSA	47	159	2	10	11	229	95.9	94.1
SSB	21	195	0	8	5	229	100.0	96.1
Sm	48	156	1	10	14	229	98.0	94.0
RNP/Sm	50	155	0	14	10	229	100.0	91.7
Jo-1	21	204	0	1	3	229	100.0	99.5
SCL-70	31	183	3	2	10	229	91.2	98.9

Table 2 - Summary of Method Comparison Study Results

	BeadChip					% PositiveAgreement	% NegativeAgreement	% TotalAgreement
SSA	POS	NEG	EQU	sub-total
	POS	47	2	1	49	95.9%	94.1%	94.5%
Predicate	NEG	10	159	8	169
	ND	1	1			(47/49)	(159/169)	(206/218)
	sub-total	57	161		218
SSB		BeadChip				% PositiveAgreement	% NegativeAgreement	% TotalAgreement
		POS	NEG	EQU	sub-total
Predicate	POS	21	0	0	21	100.0%	96.1%	96.4%
	NEG	8	195	5	203
	ND	0	0			(21/21)	(195/203)	(216/224)
sub-total		29	195		224

Sm		BeadChip			% PositiveAgreement	% NegativeAgreement	% TotalAgreement
		POS	NEG	EQU	sub-total
Predicate	POS	48	1	0	49	98.0%	94.0%	94.9%
	NEG	10	156	13	166
	ND	1	0			(48/49)	(156/166)	(204/215)
	sub-total	58	157		215

Sm/RNP				BeadChip		% PositiveAgreement	% NegativeAgreement	% TotalAgreement
		POS	NEG	EQU	sub-total
	POS	50	0	0	50	100.0%	91.7%	93.6%
	NEG	14	155	9	169
PredicateBioArray Solutions, Ltd. 1	ND		0			(50/50)	(155/169)
	sub-total	64	155		219

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Jo-1		BeadChip				% PositiveAgreement	% NegativeAgreement	% TotalAgreement
		POS	NEG	EQU	sub-total
Predicate	POS	21	0	0	21	100.0%	99.5%	99.6%
	NEG	1	204	3	205
	ND	0	0			(21/21)	(204/205)	(225/226)
sub-total		22	204		226

SCL-70		BeadChip				% PositiveAgreement	% NegativeAgreement	% TotalAgreement
		POS	NEG	EQU	sub-total
Predicate	POS	31	3	9	34	91.2%	98.9%	97.7%
	NEG	2	183	1	185
	ND	0	0			(31/34)	(183/185)	(214/219)
	sub-total	33	186		219

Reproducibility Studies -

Day to day reproducibility. The day-to-day reproducibility study was conducted with a pooled positive sample (PDP) containing antibodies to SSA, SSB, Sm, Sm/RNP, Jo-1, and SCL-70 and a pooled normal serum sample (PNS). The ENA IgG BeadChip assay was performed in duplicate for ten consecutive days for a total of twenty runs per sample using three lots of BeadChips. The pooled positive and negative controls were prepared, aliquoted, and stored in a –20°C freezer. A new aliquot was used each day to prepare fresh dilutions. The three lots of BeadChips were manufactured from three independently coupled ENA bead libraries.

The results for the pooled positive sample are reported by antigen, including the mean of the relative activity (RA), standard deviation (SD), and the coefficient of variance (CV) for each lot (intra-lot reproducibility) and the MEAN, SD, and CV of relative activity of all three lots (inter-lot reproducibility). The RA is the ratio between the antigen Normalized Intensity (NMI) and the lot specific cutoff multiplied by 100. Please refer to the Normal Range/Cutoff section in the original submission for further information regarding the cutoff values.

Negative sample were studied and the results were acceptable

Table 3 - Day to Day Reproducibility - Pooled Positive Sample

INTRA-LOT 10-DAYREPRODUCIBILITY	RELATIVE ACTIVITY (RA)		SSA	SSB	Sm	RNP/Sm	Jo-1	SCL-70

Lot-A (n=20)	MEAN	826.1	423.4	661.1	1016.0	458.6	123.3
	SD	92.5	50.7	78.6	125.3	62.2	14.0
	CV(%)	11.2	12.0	11.9	12.3	13.6	11.3
Lot-B (n=20)	MEAN	890.3	435.4	777.6	1198.9	549.8	135.3
	SD	76.1	64.4	123.3	120.1	69.1	18.6
	CV(%)	8.5	14.8	15.9	10.0	12.6	13.7
Lot-C (n=20)	MEAN	776.5	442.7	751.1	1115.6	522.8	136.3
	SD	56.4	37.4	87.7	88.8	54.7	15.0
	CV(%)	7.3	8.4	11.7	8.0	10.5	11.0
INTER-LOT	Lot-A,B,C(n=60)	MEAN	831.0	433.9	730.0	1110.2	510.4	131.6
		SD	88.6	51.7	109.0	133.9	72.4	16.8
		CV(%)	10.7	11.9	14.9	12.1	14.2	12.7

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Operator-to-operator reproducibility. The operator reproducibility was conducted with the pooled positive control, the pooled negative control, and ten disease positive samples. Two researchers performed the ENA IgG BeadChip assays in duplicate. The results are summarized in Table 4, including the mean, standard deviation, and CVs of the relative activity. The CVs were less than 10% for all positive signals; PNS-10 is a pooled negative control and the CV for the weak nonspecific signals for each antigen are much higher compared to disease positive markers.

Sample ID	Marker	MeanRA	SDRA	CV (%)
AAB206	Sm	312.2	29.7	9.52
AAB206	Sm/RNP	594.1	44.4	7.47
AAB237	Sm/RNP	512.9	40.3	7.86
AAB241	SSA	848.3	61.8	7.28
AAB266	SSA	860.8	35.3	4.10
AAB266	SSB	341.8	12.3	3.59
AAB273	SSB	612.8	33.3	5.43
AAB293	SCL-70	90.8	7.6	8.42
AAB297	SCL-70	111.4	9.5	8.50
AAB313	Jo-1	281.0	24.4	8.68
AAB315	Jo-1	262.8	14.0	5.32
AAB376	Sm	401.7	37.8	9.42
PDP-30	SSA	352.6	22.7	6.44
PDP-30	SSB	218.1	10.3	4.70
PDP-30	Sm	419.0	9.3	2.23
PDP-30	Sm/RNP	596.5	5.7	0.95
PDP-30	Jo-1	280.2	25.4	9.05
PDP-30	SCL-70	76.4	2.9	3.77
PNS-10	SSA	7.4	9.4	127.18
PNS-10	SSB	3.8	2.6	67.82
PNS-10	Sm	13.3	3.0	22.74
PNS-10	Sm/RNP	28.3	6.5	23.12
PNS-10	Jo-1	14.2	4.0	28.25
PNS-10	SCL-70	16.4	1.9	11.83

Table 4 - Operator to Operator Reproducibility

Note:

Two researchers performed the assay in duplicate, separately (4 runs in total). 2) PNS-10: 1:10 diluted pooled normal serum sample 3) PDP-30: 1:30 diluted pooled disease positive sample

Site to site reproducibility. A site-to-site reproducibility study was performed to assess the assay variability between sites, instruments, and operators. Identical serum samples (commercially obtained) were provided to the three testing sites for on-site testing. A histocompatibility and immunocompatibility laboratory holding both CLIA and ASHI certifications was used as one of the testing sites. The second site was a CLIA certified laboratory specializing in providing diagnostic services related to women's health. BioArray Solutions in-house facilities were used for the third site. These samples were randomly encoded to eliminate any references to identity or diagnosis prior to distributing the samples to the investigational sites. A total of 176 samples comprised of 52 normal samples and approximately 25 positive samples for each antigen were used. A total of 192 samples were run at each site. Ten samples were excluded due to specimen control failure at one or more sites and one sample was excluded due to a sample preparation error. Results for two samples for the Scl-70 marker were excluded due to cluster QC failure at one site. These samples were not repeated at that site.

Comparative analysis of the results obtained from two sites showed that the total agreement of positive/negative calls between two sites for SSA, SSB, Sm, Sm/RNP, JO-1, and SCL-70 is 97.2%, 95.6%, 96.7%, 90.6%, 97.2% and 96.1% respectively.

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	+/+/+	-/-	?/?/?	-/?	+/?	+/-	Total #	TotalAgreement(%)
SSA	38	138		3	2		181	97.2
SSB	35	137	1	5	2	1	181	95.6
SM	40	135		5	1		181	96.7
RNP/Sm	38	125	1	15	1	1	181	90.6
Jo-1	37	138	1	3	1	1	181	97.2
SCL-70	27	144	1	5	2		179	96.1
Note:	(+) Positive	(-) Negative	(?) Equivocal

Table 5 - Three Site Comparison of 181 Assays including Positive and Negative Controls

Normal Range, Cutoff, and Analytical sensitivity

Normal range and cutoff. To determine the normal range for each antigen in the ENA IgG Beadchip assay, one hundred thirty normal samples from healthy, asymptomatic human subjects were assayed. The mean and standard deviation of the relative activity (RA) is listed in Table 6. The upper limit of the normal range for each antigen is the mean plus 3~3.5 standard deviations (SD) and the lower limit of the positive range (Cutoff) for each antigen is the mean plus six SD.

(RA Value)	SSA	SSB	Sm	Sm/RNP	Jo-1	SCL-70
Data Points Used	130	130	129	130	130	130
MEAN	5.7	6.0	11.6	16.7	9.2	21.0
SD	15.9	15.5	15.0	14.0	15.1	13.2
Upper limit - normal range	60	60	60	60	60	60
Positive Cutoff	100	100	100	100	100	100

Table 6 - Cutoff Determination

Note: One sample was eliminated for the Sm antigen using the Dixon D/R ratio method (NCCLS C28-A2).

Analytical sensitivity- limit of blank. To determine the sensitivity of the limit of blank was determined using assays performed with sample diluent in place of serum during the sample incubation. A total of seven assays were performed. The mean and SD of the RA for each antigen are given in Table 7.

				Table 7 - Limit of Blank with Sample Diluent
--	--	--	--	----------------------------------------------

RA	SSA	SSB	Sm	RNP/Sm	Jo-1	SCL-70
Mean	2.4	0.3	2.0	2.9	0.4	1.2
STD	3.6	1.3	0.7	2.9	0.7	0.3
Mean+3xSTD	13.3	4.2	4.1	11.6	2.4	2.1

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Cross Reacting Substances

Anti-ds-DNA antibodies. To test whether the anti-ds-DNA antibodies cross-react with the BeadChip ENA antigen panel, six purchased samples characterized by the vendor as positive for anti-ds-DNA were tested side by side with the BeadChip and the predicate device. Both the BeadChip and the were tested anti-SSA reactivity in three of the six samples. In addition, two of the three predicate dolotics and GSA also tested positive for anti-SSB antibodies with the BeadChip but not with the predicate. Competitive inhibition assays confirmed that the observed anti-SSA and anti-SSB with the predicate. Oompokine finnishion addres. No cross-reaction was detected from the anti-ds-DNA antibodies.

Rheumatoid Factor (RE). To test whether rheumatoid factor cross-reacts with the BeadChip ENA rdicumator ruscer (* ); } + + + + + = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = annigen partify the BeadChip. One sample showed weak anti-SSA and anti-RNP activities while were toolou with the betivity to any antigen. The RF samples were spiked into a weak positive the other and reading to and observed activity was additive. Competitive inhibition assays confirmed that the observed anti-Sm/RNP activity was independent of the rheumatoid factor activity. No cross-reaction was detected from the rheumatoid factor.

Interference Substances

Hemolytic and lipidemic samples. To investigate the performance of the ENA IgG BeadChip Test If it the presence of potential interferents, a hemolytic sample was identified from the normal oyoten in the prooms of processes in the disease samples. These two samples were added at a 1:10 dilution to the pooled positive control. The hemolytic sample did not have significant effect on assay performance, while the lipidemic sample showed apparent interference with the assay, including inhibition of the protein L activity resulting in a chip QC failure. It is recommended that lipidemic samples not be used with the BeadChip.

Additionally, PDP-90 samples were titrated with purified hemoglobin and bilirubin purchased from Auditionally, FBF the operating range of the assay in the presence of these substances. Bilirubin at Oncentrations of 10, 20, and 40 mg/dl and hemoglobin at concentrations of 250, 500, and 1000 mg/dl were not found to interfere with the assay within the tested limits.

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Image /page/7/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three lines representing its body and wings. The eagle is facing right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle.

Public Health Service

MAY 3 1 2005

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

BioArray Solutions, Ltd. c/o Mr. Kevin Wyckoff Quality Assurance & Regulatory Affairs Manager 35 Technology Drive Suite 100 Warren, NJ 07059

Re: K043067

Trade/Device Name: ENA IgG BeadChip™ Test System on the Array Imaging System (AIS 400) Regulation Number: 21 CFR 866.5100 Regulation Name: Antinuclear antibody immunological test system Regulatory Class: Class II Product Code: LLL Dated: November 5, 2004 Received: November 8, 2004

Dear Mr. Wyckoff:

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

{8}------------------------------------------------

Page 2 - Mr. Kevin Wyckoff

systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0131. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address

http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours.

Robert L. Beckerf

Robert L. Becker, Jr., M.D., Ph 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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INDICATIONS FOR USE STATEMENT

510(k) Number (if known): K043067

Device Name: ENA IgG BeadChip™ Test System

Indications For Use:

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use

(Per 21 CFR 801.109)

Over-The-Counter Use (Optional Format 1-2-96)

Mana M. Khan

Division Sign-Off

Office of In Vitro Dlagnostic Device Evaluation and Sately

510(k) K043067

Regulation Number and Section

§ 866.5100 Antinuclear antibody immunological test system.

(a)
Identification. An antinuclear antibody immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the autoimmune antibodies in serum, other body fluids, and tissues that react with cellular nuclear constituents (molecules present in the nucleus of a cell, such as ribonucleic acid, deoxyribonucleic acid, or nuclear proteins). The measurements aid in the diagnosis of systemic lupus erythematosus (a multisystem autoimmune disease in which antibodies attack the victim's own tissues), hepatitis (a liver disease), rheumatoid arthritis, Sjögren's syndrome (arthritis with inflammation of the eye, eyelid, and salivary glands), and systemic sclerosis (chronic hardening and shrinking of many body tissues).(b)
Classification. Class II (performance standards).