The EUROIMMUN Anti-ENA Pool ELISA (IgG) is intended for the qualitative determination of IgG class antibodies against nuclear antigens (mixture of nRNP/Sm, Sm, SS-A (SS-A 60/Ro-52), SS-B, Scl-70 and ribosomal P proteins) in human serum. It is used as an aid in the diagnosis of mixed connective tissue diseases (MCTD), systemic lupus erythematosus, Sjögren's syndrome and progressive systemic sclerosis, in conjunction with other laboratory and clinical findings.

Device Description

The EUROIMMUN Anti-ENA Pool Screen ELISA (IgG) consists of a microwell ELISA plate coated with a mixture of nRNP/Sm, Sm, SS-A (SS-A 60/Ro-52), SS-B, Scl-70 and ribosomal P proteins and antigens, calibrator, positive and negative control, peroxidase-labelled anti-human IgG conjugate, sample buffer, wash buffer concentrate, TMB chromogen/substrate solution and stop solution.

AI/ML Overview

This document describes the performance of the EUROIMMUN Anti-ENA Pool ELISA (IgG) for the qualitative determination of IgG class antibodies against nuclear antigens.

1. Table of Acceptance Criteria (Implied) and Reported Device Performance:

The document doesn't explicitly state "acceptance criteria" with specific numerical thresholds for sensitivity and specificity that had to be met. Instead, it presents the results of clinical studies. The implied acceptance is that the device demonstrates adequate diagnostic performance for its intended use, particularly for aiding in the diagnosis of specific autoimmune diseases. The performance data is presented below:

Performance Metric	Reported Device Performance (95% Confidence Interval)
Overall Sensitivity	60.9% (54.7 - 66.9%)
Overall Specificity	96.5% (92.5 - 98.7%)

Detailed Clinical Sensitivity by Panel:

Panel	n	% Positive	95% C.I.
Mixed connective tissue disease	44	100.0%	92.0 - 100.0%
Systemic lupus erythematosus	85	55.3%	44.1 - 66.1%
Systemic sclerosis	66	45.5%	33.1 - 58.2%
Sjögren's syndrome	66	72.7%	60.4 - 83.0%

Detailed Clinical Specificity by Panel:

Panel	n	% Negative	95% C.I.
Polymyositis/dermatomyositis	26	84.6%	65.1 - 95.6%
Celiac disease	21	100.0%	83.9 - 100.0%
Wegener's granulomatosis	17	88.2%	63.6 - 98.5%
Rheumatoid arthritis	39	100.0%	91.0 - 100.0%
Other autoimmune diseases*	52	100.0%	93.2 - 100.0%
Bacterial/viral infections	16	100.0%	79.4 - 100.0%

2. Sample Size for Test Set and Data Provenance:

Clinical Studies (Test Set): A total of 432 clinically characterized samples were investigated for ENA antibodies (IgG). The document does not specify the country of origin, but the context of an FDA submission suggests general compliance with US regulatory standards, and it states samples were "obtained from different sources," implying a diverse, possibly multicenter, collection. The samples are described as "clinically characterized," indicating they are from patients with confirmed diagnoses and control groups. This makes the study prospective in nature, as samples were characterized based on clinical findings and then tested.
Method Comparison with Predicate Device: 278 clinically characterized samples were used. These samples were also from patients and control groups (49 mixed connective tissue diseases, 26 systemic lupus erythematosus, 29 Sjögren's syndrome, 22 systemic sclerosis, 20 polymyositis, 10 celiac disease, 17 Wegener's granulomatosis, 39 rheumatoid arthritis, 16 infectious disease and 50 healthy).
Traceability (CDC ANA reference panel): The reactivity of the assay was verified using the CDC ANA reference panel. This implies a reference panel from the Centers for Disease Control and Prevention (USA).

3. Number of Experts and Qualifications:

The document mentions "clinically characterized samples" and "cooperation with different sites" for clinical studies. It also states that the predicate device comparison used "clinically characterized samples." However, it does not specify the number of experts used to establish the ground truth or their specific qualifications (e.g., "radiologist with 10 years of experience"). Clinical characterization typically involves a team of healthcare professionals (physicians, specialists) making diagnoses based on a variety of clinical and laboratory findings.

4. Adjudication Method:

The document does not describe any specific adjudication method (e.g., 2+1, 3+1) for the test set. The ground truth relies on "clinically characterized samples," meaning the diagnoses were established through routine clinical practice, which may involve consensus among treating physicians but not necessarily a formal adjudication process for research purposes.

5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study:

No MRMC study was performed or reported. This device is an in vitro diagnostic (IVD) test, not an imaging device that would typically involve human readers interpreting results with and without AI assistance. The comparison was against a predicate device (another ELISA test), not against human interpretation of raw data.

6. Standalone Performance:

Yes, a standalone performance study was done. The clinical sensitivity and specificity reported are for the device (algorithm) only (EUROIMMUN Anti-ENA Pool ELISA (IgG)) against the clinical ground truth.

7. Type of Ground Truth Used:

The ground truth used was expert consensus / clinical findings. The samples were described as "clinically characterized," meaning the diagnoses for the various autoimmune diseases and control conditions were established based on a combination of medical history, physical examination, laboratory tests (other than the device being tested), and specialist consultations, reflecting the "gold standard" of clinical diagnosis for these conditions.

8. Sample Size for Training Set:

The document does not explicitly mention a separate "training set" for the device's development. This is typical for ELISA-based diagnostic kits, where the assay design is based on established immunochemical principles and antigen selection rather than machine learning models that require distinct training and test sets. The studies described (reproducibility, analytical specificity, clinical validation) function more as verification and validation of a pre-defined assay.

9. How Ground Truth for Training Set Was Established:

As no explicit training set is mentioned in the context of machine learning, this question is not directly applicable. For the development of the assay, the selection of the specific antigens (nRNP/Sm, Sm, SS-A (SS-A 60/Ro-52), SS-B, Scl-70, and ribosomal P proteins) would have been based on established scientific literature and clinical relevance to the target autoimmune diseases, likely informed by studies that linked these antibodies to specific clinical conditions. The "ground truth" for antigen selection and assay design would be the medical understanding of these disease biomarkers.

Summary

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EUROIMMUN US INC.

APR 0 9 2013

PREMARKET NOTIFICATION 510(K) SAFETY AND EFFECTIVENESS SUMMARY (as required by 21 CFR § 807.92)

A. 510(k)Number: K112996
B. Purpose for Submission: New device
C. Measurand: Anti-nuclear antibodies
D. Type of Test: Qualitative enzyme immunoassay
E. Applicant:
- EUROIMMUN US INC.
E. Proprietary and Established Names: EUROIMMUN Anti-ENA Pool ELISA (IgG)
G. Regulatory Information:
- Regulation: 1.
  - 21 CFR 866.5100 Antinuclear antibody immunological test system
  - 1. Classification:
  - Class II 3. Product code:
  - LJM
  - 1. Panel:

Immunology

H. Intended Use:

1. Intended use(s):
  The EUROIMMUN Anti-ENA Pool ELISA (IgG) is intended for the qualitative determination of IgG class antibodies against nuclear antigens (mixture of nRNP/Sm, Sm, SS-A (SS-A 60/Ro-52), SS-B, Scl-70 and ribosomal P proteins) in human serum. It is used as an aid in the diagnosis of mixed connective tissue diseases (MCTD), systemic lupus erythematosus, Sjögren's syndrome and progressive systemic sclerosis, in conjunction with other laboratory and clinical findings.
1. Indication(s) for use:
- Same as intended use.
1. Special conditions for the use statement(s): For prescription use only.
র্য . Special instrument requirements:

Microwell plate reader capable of measuring OD at 450nm for dual wavelength readings.

l, Device Description:

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J. Substantial Equivalence Information:

Predicate device name (s): 1. Aesku Aeskulisa ANA Hep-2
Predicate 510(k) number(s): 2. K081104
1. Comparison with predicate:

Similarities
Item	New Device	Predicate Device
Intended use	Detection of IgG antibodies to nuclear antigens	Same
Assay format	Qualitative	Same
Technology	ELISA	Same
Assay platform	96-well microtiter plates	Same
Calibration	Relative evaluation	Same
Conjugate	Anti-human IgG labeled with horseradish peroxidase	Same
Substrate	TMB	Same
Sample types	Serum	Same
Procedure	Sample incubation with micro-well antigen coated plate.followed by a wash step, incubation with an anti-humanIgG enzyme conjugate; wash step, incubation withsubstrate; then the addition of a stop solution andreading at 450nm.	Same
Reported results	OD Ratio	Same
Cut off level	Ratio 1.0	Same
Differences
Item	New Device	Predicate Device
Antigen mixture	nRNP/Sm, Sm, SS-A (SS-A 60/Ro-52), SS-B, Scl-70and ribosomal P proteins	dsDNA, histones, SS-A (Ro), SS-B (La), Sm,snRNP/Sm, Scl-70, Jo-1 and centromeric antigens andlysed HEp-2 cells
Calibrators and controls	1 calibrator2 controls: 1 positive, 1 negative	3 controls: 1 positive, 1 cut-off (used for calculation ofresults), 1 negative
Sample buffer	Ready for use	5x concentrate
Wash buffer	10x concentrate	50x concentrate
Stop solution	0.5 M sulphuric acid	1 M hydrochloric acid
Sample dilution	1:201	1:101

Standard/Guidance Document Referenced (if applicable): K.

Guidance for Industry and FDA Staff: Recommendations for Antibody (ANA) Test System Premarket (510(k)) Submissions (January 22, 2009)

L. Test Principle:

Patient samples are diluted 1:201 in sample buffer, 100 µl of each diluted patient sample and pre-diluted controls and calibrator are added to the antigen mixture coated microtiter wells and incubated for 30 minutes at room temperature. After incubation the microtiter well strips are washed with wash buffer to remove unbound antibodies and 100 µl of the anti-human lgG enzyme conjugate reagent is added to each microtiter well. After an additional 30-minutes incubation at room temperature, the microtiter wells are again washed 3 times with 300 µl of wash buffer to remove any unbound enzyme conjugate and 100 µl of the chromogen substrate is added. The strips are incubated for 15 minutes at room temperature and 100 ul stop solution is added. The microtiter plates are placed in an ELISA reader and read at a wavelength of 450 nm and a reference wavelength of between 620 nm and 650 nm within 30 minutes.

M. Performance Characteristics (where applicable):

1. Analytical performance:

Precision/Reproducibility: a.

The reproducibility of the test was investigated using sera with different concentrations. Intra-assay reproducibility is based on 20 determinations and inter-assay reproducibility on 30 determinations performed in 10 different runs on 5 days with 2 runs per day, each run performed with 3 replicates according to the package insert. The following results were obtained:

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Intra-Assay Reproducibility .

n = 20				Anti-ENA Pool ELISA (IgG) Ratio
	Sample 1	Sample 2	Sample 3	Sample 4	Sample 5	Sample 6	Sample 7	Sample 8
Mean Value (x):	0.4	0.8	1.4	2.4	5.7	8.3	0.1	7.4
Range of Values:	0.3 - 0.4	0.7 - 0.8	1.3 - 1.4	2.2 - 2.6	5.4 - 6.0	7.8 - 9.0	0.1	6.8 - 7.6
Expected Result:	negative	negative	positive	positive	positive	positive	negative	positive
% positive:	0%	0%	100%	100%	100%	100%	0%	100%
% negative:	100%	100%	0%	0%	0%	0%	100%	0%
	Sample 9	Sample 10	Sample 11	Sample 12	Sample 13	Sample 14	Sample 15	Sample 16
Mean Value (x):	2.8	4.9	2.5	8.3	10.3	2.1	5.6	2.8
Range of Values:	2.5 - 3.0	4.7 - 5.2	2.1 - 2.7	8.0 - 8.6	9.5 - 11.1	2.0 - 2.3	4.9 - 6.2	2.5 - 3.0
Expected Result:	positive	positive	positive	positive	positive	positive	positive	positive
% positive:	100%	100%	100%	100%	100%	100%	100%	100%
% negative:	0%	0%	0%	0%	0%	0%	0%	0%

Table 5.1.1.2 Inter-assay reproducibility

n = 30	Anti-ENA Pool ELISA (IgG) Ratio
	Sample 1	Sample 2	Sample 3	Sample 4	Sample 5	Sample 6	Sample 7
Mean Value (x):	0.4	0.8	1.3	2.7	5.6	8.4	0.2
Range of Values:	0.3 - 0.5	0.7 - 0.9	1.2 - 1.4	2.5 - 3.0	4.9 - 6.1	7.6 - 9.1	0.2 - 0.3
Expected Result:	negative	negative	positive	positive	positive	positive	negative
% positive:	0%	0%	100%	100%	100%	100%	0%
% negative:	100%	100%	0%	0%	0%	0%	100%
	Sample 8	Sample 9	Sample 10	Sample 11	Sample 12	Sample 13	Sample 14
Mean Value (x):	6.5	2.0	3.5	1.8	6.8	7.1	2.0
Range of Values:	5.3 - 7.3	1.5 - 2.8	2.6 - 4.9	1.1 - 2.1	5.4 - 8.9	4.5 - 9.8	1.6 - 2.4
Expected Result:	positive	positive	positive	positive	positive	positive	positive
% positive:	100%	100%	100%	100%	100%	100%	100%
% negative:	0%	0%	0%	0%	0%	0%	0%

The Lot to lot reproducibility was investigated during the validation and quality control of the kit using different lots with QC samples distributed over the measurement range. The following results were obtained:

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EUROIMMUN US INC.

Lot to Lot Reproducibility

	Sample 1Ratio	Sample 2Ratio	Sample 3Ratio	Sample 5Ratio	Sample 6Ratio	Sample 7Ratio	Sample 8Ratio
n:	6*	6*	11**	9**	11**	11**	9**
Mean Value (x):	1.1	0.9	0.1	2.7	3.6	5.0	8.5
Range of Values:	1.1 - 1.2	0.8 - 0.9	0.1 - 0.2	2.5 - 3.3	3.0 - 4.2	4.1 - 5.7	7.0 - 9.8
Expected Result:	positive	negative	negative	positive	positive	positive	positive
% positive:	100%	0%	0%	100%	100%	100%	100%
% negative:	0%	100%	100%	0%	0%	0%	0%

Anti-ENA Pool ELISA (IgG)

Omitte. Replaced by Sample 14

Anti-ENA Pool ELISA (IgG)

	Sample 9	Sample 10	Sample 11	Sample 12	Sample 13	Sample 14	Sample 15	Sample 16
	Ratio	Ratio	Ratio	Ratio	Ratio	Ratio	Ratio	Ratio
n:	6*	6*	6*	6*	6*	6*	6*	6*
Mean Value (x):	0.2	6.3	2.4	3.9	2.2	6.8	8.2	2.0
Range of Values:	0.1 - 0.3	5.5 - 7.6	1.9 - 3.0	2.9 - 5.2	1.9 - 2.7	5.9 - 8.2	7.0 - 9.7	1.8 - 2.3
Expected Result:	negative	positive	positive	positive	positive	positive	positive	positive
% positive:	0%	100%	100%	100%	100%	100%	100%	100%
% negative:	100%	0%	0%	0%	0%	0%	0%	0%

*3 lots x 2 runs

** n lots x 1 run :

Additional Samplex Run

No.	Lot	Test	Sample 9Ratio	Sample 10Ratio	Sample 11Ratio	Sample 12Ratio
1	1	1	0.1	7.6	3.0	5.2
2	2	2	0.1	7.5	2.9	5.0
3	3	3	0.3	5.8	2.1	3.4
4	4	4	0.3	6.0	2.2	3.4
5	5	5	0.3	5.5	1.9	3.2
6	6	6	0.3	5.5	2.0	2.9
No.	Lot	Test	Sample 13Ratio	Sample 14Ratio	Sample 15Ratio	Sample 16Ratio
1	1	1	2.7	8.1	9.7	2.3
2	2	2	2.7	8.2	9.7	2.2
3	3	3	2.0	6.1	7.9	1.8
4	4	4	2.0	6.4	7.4	1.8
5	5	5	1.9	5.9	7.4	1.9

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b. Linearity/assay reportable range: Not applicable.
High dose Hook effect C.

Potential for a high dose Hook effect is a phenomenon that is inherent with one step "sandwich" assay designs: Very high concentrations of antigen in the patient sample bind to all available sites saturating them - on both the antibody-solid phase and the antibody-labeled conjugate and thereby prevent the "sandwich" formation. Under these conditions, the measured level of analyte may be significantly lower than the actual level present in the sample. The two-step immunoassay design of the Anti-ENA Pool ELISA (IgG) eliminates the adverse contribution of binding proteins, endogenous interfering substances and general matrix effects due to the extra wash step.

ರ. Traceability, Stability, Expected values (controls, calibrators or methods). A recognized standard or reference material for anti-nuclear antibodies is not available. Results of this assay are given in ratios. The reactivity of the Anti-ENA Pool ELISA (IgG) was verified using the CDC ANA reference panel.
Limit of detection: e. Not applicable.

f. Analytical specificity:

Cross-reactivity: The quality of the antigen mixture coated on the plates, containing the antigens nRNP/Sm, Sm, SS-A (SS-A 60/Ro-52), SS-B, Scl-70 and ribosomal P-proteins, ensures a high specificity of the ELISA. The reactivity of the assay was confirmed using the CDC ANA reference panel. CDC sample No. 10, characterized as anti-Jo-1 positive, was found positive due to Ro-52 antibodies which commonly occur in anti-Jo-1 positive samples. As the definition of CDC sample No. 10 did not include a check for Ro-52 antibodies, anti-Jo-1 positive samples that were negative for anti-Ro-52 were tested and found negative, while samples positive for both anti-Ro-52 were found positive, so no cross-reactivity to Jo-1 is expected. Cross reactivity was investigated using a total of 82 clinically and serologically characterized samples (10 celiac disease for antibodies against gliadin and tissue transglutaminase, 17 Wegener's granulomatosis for ANCA, 39 rheumatoid arthritis for antibodies against CCP and 16 infectious diseases antibody positive samples). All except of 2 samples were negative in the Anti-ENA Pool ELISA (IgG), so no cross reactivity is expected.

Interference: To investigate the influence from hemoglobin, triglycerides and bilirubin, 4 different specimens at different ANA concentrations (ratio 0.7 - 8.4) were spiked with potential interfering substances and were incubated with the test system. The recovery in relation to the unspiked sample without interferent was calculated. The individual recovery of the positive or borderline samples was within the range of 91 - 105 %. No significant interference was observed for concentrations of up to 1000 mg/dl for hemogiobin, 2000 mg/dl for triglyceride and 40 mg/dl for bilirubin. Furthermore, the influence from rheumatoid factor was investigated by spiking of 6 different speciments with a rheumatoid factor positive material (characterized nephelometrically). The recovery in relation to the original sample (not spiked) was calculated. The recoveries were found within 96 - 106%. No interference was observed with rheumatoid factor at 500 IU/ml.

Assay cut-off: g.
Ratio 1.0

2. Comparison studies:

a. Method comparison with predicate device:
A comparison study was performed using 278 clinically characterized samples from patients and control groups (49 mixed connective tissue diseases, 26 systemic lupus erythematosus, 29 Syögren's syndrome, 22 systemic sclerosis, 20 polymyositis, 10 celiac disease, 17 Wegener's granulomatosis, 39 rheumatoid arthritis, 16 infectious disease and 50 healthy), obtained from different sources. The panel consisted of 100 men with 14 unknown. Age ranged from 7 to 87 years with an average age of 46 years (15 unknown). The samples were tested with the EUROIMMUN Anti-ENA Pool ELISA (IgG) and with the Aesku Aeskulisa ANA Hep-2 as the predicate device. The results are shown in the table below. All discrepant samples were from controls.

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n = 278						Predicate ELISA
						positive	negative
EUROIMMUN	positive		135				1
Anti-ENA Pool ELISA (IgG)	negative		3				139
Negative agreement	139	/	140	=	99.3%	95% C.I.:	96.1%	-	100.0%
Positive agreement	135	/	138	=	97.8%	95% C.I.:	93.8%	-	99.5%
Overall agreement	274	/	278	=	98.6%	95% C.I.:	96.4%	-	99.6%

b. Matrix comparison: Not applicable.

3. Clinical studies:

Clinical studies were performed in cooperation with different sites. In total 432 clinically characterized samples were investigated for ENA antibodies (IgG). The EUROIMMUN Anti-ENA Pool ELISA (IgG) showed an overall sensitivity of 60.9% (95% C.I.: 54.7 - 66.9%) and a specificity of 96.5% (95% C.I.: 92.5 - 98.7%). The results are shown in the table below. 95% C.I. are calculated by the exact method.

Clinical sensitivity: a.

No.	Panel	n	Anti-ENA Pool ELISA (IgG)
			positive	%	95% C.I.
1	Mixed connective tissue disease	44	44	100.0%	92.0 - 100.0%
2	Systemic lupus erythematosus	85	47	55.3%	44.1 - 66.1%
3	Systemic sclerosis	66	30	45.5%	33.1 - 58.2%
4	Sjögren's syndrome	66	48	72.7%	60.4 - 83.0%
	Total	261	159	60.9%	54.7 - 66.9%

b. Clinical specificity:

No.	Panel	n	Anti-ENA Pool ELISA (IgG)
			negative	%	95% C.I.
5	Polymyositis/dermatomyositis	26	22	84.6%	65.1 - 95.6%
6	Celiac disease	21	21	100.0%	83.9 - 100.0%
7	Wegener's granulomatosis	17	15	88.2%	63.6 - 98.5%
8	Rheumatoid arthritis	39	39	100.0%	91.0 - 100.0%
9	Other autoimmune diseases*	52	52	100.0%	93.2 - 100.0%
10	Bacterial/viral infections	16	16	100.0%	79.4 - 100.0%
	Total	171	165	96.5%	92.5 - 99.7%

from the following groups: AIH (n = 8), Grave's disease (n = 12), Hashimoto (n = 11), Diabetes Type I (n = 12)

Other clinical supportive data (when a. and b. are not applicable): C. Not applicable.

Clinical cut-off: 4.

See Assay cut-off.

Expected values/Reference range: 5.
The levels of ANA (IgG) were analyzed in a panel of 200 samples from apparently healthy blood donors (mixed age and sex). The results are shown in the table below.

n	200
Positives	3
Negatives	197
Prevalence	1.5%
	Ratio
Lowest value	0.0
Highest value	5.0
Mean value	0.2
Std deviation	0.37

N. Proposed Labeling:

The labeling is sufficient and it satisfies the requirements of 21 CFR Part 809.10.

0. Conclusion:

The submitted information in this premarket notification is complete and supports a substantial equivalence decision.

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EUROIMMUN US INC.

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03.2013

Date

Michael Locke

Signature

Michael Locke, Dir. Of Regulatory Affairs Typed Name, Title

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

April 9, 2013

Euroimmun US Inc. c/o Ms. Kathryn Kohl Managing Director 1100 The American Road Morris Plains, NJ 07950

Re: K112996

Trade/Device Name: EUROIMMUN Anti-ENA Pool ELISA (IgG) Regulation Number: 21 CFR §866.5100 Regulation Name: Antinuclear Antibody Immunological Test System Regulatory Class: Class II Product Code: LLL Dated: March 28, 2013 Received: April 3, 2013

Dear Ms. Kohl:

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 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

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Page 2 – Ms. Kathryn Kohl

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.lda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm I 15809.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/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Maria M. Chan -S

Maria M. Chan, Ph.D. Director Division of Immunology and Hematology Devices Office of In Vitro Diagnostics and Radiological Health

Center for Devices and Radiological Health

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Indications for Use

510(k) Number (if known): K112996

Device Name: EUROIMMUN Anti-ENA Pool ELISA (IgG)

Indications For Use:

The EUROIMMUN Anti-ENA Pool ELISA (IgG) is intended for the qualitative determination of IgG class antibodies against nuclear antigens (mixture of nRNA/Sm, Sm, SS-A (SS-A 60/Ro-52), SS-B, Scl-70, and ribosomal P proteins) in human serum. It is used as an aid in the diagnosis of mixed connective tissue disease (MCTD), systemic lupus erythematosus, Sjögren's syndrome and progressive systemic sclerosis, in conjunction with other laboratory and clinical findings.

Prescription Use × (Part 21 CFR 801 Subpart D)

AND/OR Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH; Office of In Vitro Diagnostics and Radiological Health (OIR)

Maria Mỹ @han -S

Division Sign-Off Office of In Vitro Diagnostics and Radiological Health

510(k) K112996

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).