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K Number
K131185
Device Name
ANA SCREEN ELISA (IGG)
Manufacturer
EUROIMMUN US
Date Cleared
2013-07-15

(80 days)

Product Code
LJM
Regulation Number
866.5100
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The EUROIMMUN ANA Screen ELISA (IgG) is intended for the qualitative determination of IgG class antibodies against nuclear antigens (mixture of dsDNA, histones, ribosomal P-proteins, rRNP/Sm, Sm, SS-A, SS-B, Scl-70, Jo-1 and centromeres) in human serum and plasma (EDTA, Li-heparin, Citrate). It is used as an aid in the diagnosis of mixed connective tissue diseases (MCTD), systemic lupus erythematosus, Sjögren's syndrome, progressive systemic sclerosis and polymyositis and dermatomyositis, in conjunction with other laboratory and clinical findings.
Device Description
The EUROIMMUN ANA Screen ELISA (IgG) consists of a microwell ELISA plate coated with a mixture of dsDNA, histones, ribosomal P proteins, nRNP/Sm, Sm, SS-A, SS-B, Scl-70. Jo-1 and centromeres antigens, calibrator, positive and negative control, peroxidaselabeled anti-human IgG conjugate, sample buffer, wash buffer concentrate, TMB chromogen/substrate solution and stop solution.
More Information

K081104

Not Found

No
The summary describes a standard ELISA assay kit for detecting antibodies and does not mention any computational or algorithmic components indicative of AI/ML.

No
This device is an in vitro diagnostic (IVD) test intended for the qualitative determination of IgG class antibodies to aid in the diagnosis of certain autoimmune diseases. It is not designed to treat or prevent a disease, which is the function of a therapeutic device.

Yes

The device's "Intended Use / Indications for Use" states it is "used as an aid in the diagnosis of mixed connective tissue diseases (MCTD), systemic lupus erythematosus, Sjögren's syndrome, progressive systemic sclerosis and polymyositis and dermatomyositis, in conjunction with other laboratory and clinical findings."

No

The device description clearly states it consists of a microwell ELISA plate, calibrator, controls, conjugates, buffers, and solutions, which are all physical components, not software.

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

Here's why:

  • Intended Use: The intended use explicitly states it's for the "qualitative determination of IgG class antibodies against nuclear antigens... in human serum and plasma". This is a classic description of an in vitro diagnostic test, as it analyzes biological samples outside of the body to provide information about a patient's health status.
  • Aid in Diagnosis: The intended use also states it is used "as an aid in the diagnosis of mixed connective tissue diseases (MCTD), systemic lupus erythematosus, Sjögren's syndrome, progressive systemic sclerosis and polymyositis and dermatomyositis". This further confirms its role in providing diagnostic information.
  • Device Description: The description details the components of an ELISA kit, which is a common format for in vitro diagnostic assays.
  • Performance Studies: The document includes performance studies (method comparison and clinical studies) with metrics like sensitivity, specificity, and agreement, which are standard for evaluating the performance of IVD devices.
  • Predicate Device: The mention of a predicate device (Aesku Aeskulisa ANA Hep-2) with a K number indicates that this device is being compared to another legally marketed IVD.

All of these factors strongly indicate that the EUROIMMUN ANA Screen ELISA (IgG) is an In Vitro Diagnostic device.

N/A

Intended Use / Indications for Use

The EUROIMMUN ANA Screen ELISA (IgG) is intended for the qualitative determination of IgG class antibodies against nuclear antigens (mixture of dsDNA, histones, ribosomal P-proteins, rRNP/Sm, Sm, SS-A, SS-B, Scl-70, Jo-1 and centromeres) in human serum and plasma (EDTA, Li-heparin, Citrate). It is used as an aid in the diagnosis of mixed connective tissue diseases (MCTD), systemic lupus erythematosus, Sjögren's syndrome, progressive systemic sclerosis and poly-/dermatomyositis, in conjunction with other laboratory and clinical findings.

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

LJM

Device Description

The EUROIMMUN ANA Screen ELISA (IgG) consists of a microwell ELISA plate coated with a mixture of dsDNA, histones, ribosomal P proteins, nRNP/Sm, Sm, SS-A, SS-B, Scl-70. Jo-1 and centromeres antigens, calibrator, positive and negative control, peroxidaselabeled anti-human IgG conjugate, sample buffer, wash buffer concentrate, TMB chromogen/substrate solution and stop solution.

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

Age ranged from 7 to 87 years with an average age of 46 years (15 unknown).

Intended User / Care Setting

For prescription use only.

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

A comparison study was performed using 158 clinically characterized samples from patients (49 MCTD, 37 systemic lupus erythematosus, 37 Sjögren's syndrome, 19 systemic sclerosis, 16 myositis) and 132 from control groups (10 celiac disease, 17 Wegener's granulomatosis, 39 rheumatoid arthritis, 16 infectious disease and 50 healthy), obtained from different sources. The panel consisted of 101 men and 174 women (and 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 ANA Screen ELISA (IgG) and with the Aesku Aeskulisa ANA Hep-2 as the predicate device.

Clinical studies were performed in cooperation with different sites. In total 738 clinically characterized samples were investigated for anti-nuclear antibodies (IgG).

The levels of ANA (IgG) were analyzed in a panel of 200 samples from apparently healthy blood donors (120 men and 80 women with an average age of 40 y; age range: 19 - 68 y).

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Precision/Reproducibility:

  • Intra-assay reproducibility: based on 20 determinations performed in 10 different runs on 5 days with 2 runs per day, each run performed with 3 replicates.
  • Inter-assay reproducibility: based on 30 determinations performed in 10 different runs on 5 days with 2 runs per day, each run performed with 3 replicates.
  • Lot to lot reproducibility: investigated during validation and quality control using different lots with QC samples distributed over the measurement range.

Analytical specificity:

  • Cross-reactivity: Investigated using 82 clinically and serologically characterized samples (10 celiac disease, 17 Wegener's granulomatosis, 39 rheumatoid arthritis, 16 infectious diseases). All but 2 samples were negative.
  • Interference: Investigated by spiking 4 different specimens with hemoglobin, triglycerides, and bilirubin. Recovery was 92 - 107%. Also investigated rheumatoid factor interference by spiking 6 different specimens; recoveries were 100 - 110%.

Comparison studies:

  • Method comparison with predicate device: 158 clinically characterized samples from patients and 132 from control groups (total 290). Tested against Aesku Aeskulisa ANA Hep-2.
    • Negative Agreement: 98.0% (95% C.I.: 94.2% - 99.6%)
    • Positive Agreement: 96.5% (95% C.I.: 92.0% - 98.8%)
    • Overall Agreement: 97.2% (95% C.I.: 94.6% - 98.8%)
  • Matrix comparison: 12 sample pairs of serum and corresponding plasma (EDTA, Li-heparin, Citrate).
    • Regression Equation (y = plasma, x = serum):
      • EDTA plasma: y = 0.04 + 0.99 x (95% C.I. intercept: -0.02 - 0.13, 95% C.I. slope: 0.96 - 1.02, R2: 0.9988, Mean % recovery: 103%, Range: 98 - 112 %)
      • Li-heparin plasma: y = -0.04 + 1.00 x (95% C.I. intercept: -0.10 - 0.01, 95% C.I. slope: 0.98 - 1.03, R2: 0.9992, Mean % recovery: 99%, Range: 90 - 109 %)
      • Citrate plasma: y = -0.00 + 0.99 x (95% C.I. intercept: -0.02 - 0.05, 95% C.I. slope: 0.95 - 1.00, R2: 0.9990, Mean % recovery: 98%, Range: 95 - 104 %)

Clinical studies:

  • Clinical Sensitivity: 738 clinically characterized samples. Overall sensitivity 72.5% (95% C.I.: 68.0 - 76.7%) for total 429 patient samples.
    • Mixed connective tissue diseases (n=21): 95.2% (76.2 - 99.9%)
    • Systemic lupus erythematosus (n=213): 73.2% (66.8 - 79.1%)
    • Poly-/dermatomyositis (n=26): 15.4% (4.4 - 34.9%)
    • Systemic sclerosis (n=81): 72.8% (61.8-82.1%)
    • Sjögren's syndrome (n=88): 81.8% (72.2 - 89.2%)
  • Clinical Specificity: Overall specificity of 95.8% (95% C.I.: 92.9 - 97.7%) for total 309 control samples.
    • Celiac disease (n=10): 100.0% (69.2-100.0%)
    • Wegener's granulomatosis (n=17): 94.1% (71.3-99.9%)
    • Rheumatoid arthritis (n=203): 94.1% (89.9-96.9%)
    • Other autoimmune diseases (n=63): 100.0% (94.3 -100.0%)
    • Bacterial/viral infections (n=16): 100.0% (79.4-100.0%)

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

Clinical Sensitivity: 72.5% (95% C.I.: 68.0 - 76.7%)
Clinical Specificity: 95.8% (95% C.I.: 92.9 - 97.7%)

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.

K081104

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

§ 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).

0

510(k) SUMMARY

A. 510(k) Number:

K131185

B. Purpose for Submission:

New device

C. Measurand:

Anti-Nuclear Antibodies

D. Type of Test:

Qualitative enzyme immunoassay

E. Applicant:

EUROIMMUN US INC.

F. Proprietary and Established Names:

EUROIMMUN ANA Screen ELISA (IgG)

G. Regulatory Information:

    1. Regulation section:
      21 CFR 866.5100 – Anti-Nuclear Antibody immunological test system
    1. Classification:
      Class II
    1. Product code:
      LJM
    1. Panel:
      Immunology

JUL 1 5 2013

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EUROIM

H. Intended Use:

1.Intended use(s):

The EUROIMMUN ANA Screen ELISA (IgG) is intended for the qualitative determination of IgG class antibodies against nuclear antigens (mixture of dsDNA, histones, ribosomal P-proteins, rRNP/Sm, Sm, SS-A, SS-B, Scl-70, Jo-1 and centromeres) in human serum and plasma (EDTA, Liheparin, Citrate). It is used as an aid in the diagnosis of mixed connective tissue diseases (MCTD), systemic lupus erythematosus, Sjögren's syndrome, progressive systemic sclerosis and polymyositis and dermatomyositis, in conjunction with other laboratory and clinical findings.

    1. Indication(s) for use:
      Same as intended use.

3. Special conditions for use statement(s):

For prescription use only.

4. Special instrument requirements:

Microwell plate reader capable of measuring OD at 450nm and at 620nm for dual wavelength readings.

I. Device Description:

The EUROIMMUN ANA Screen ELISA (IgG) consists of a microwell ELISA plate coated with a mixture of dsDNA, histones, ribosomal P proteins, nRNP/Sm, Sm, SS-A, SS-B, Scl-70. Jo-1 and centromeres antigens, calibrator, positive and negative control, peroxidaselabeled anti-human IgG conjugate, sample buffer, wash buffer concentrate, TMB chromogen/substrate solution and stop solution.

J. Substantial Equivalence Information:

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

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EUROIMMUNE US

Similarities
ItemDevicePredicate
Intended UseDetection of IgG antibodies to nuclear antigensSame
Assay FormatQualitativeSame
TechnologyELISASame
Assay Platform96-well microtiter platesSame
CalibrationRelative evaluationSame
ConjugateAnti-human IgG labeled with horseradish peroxidaseSame
SubstrateTMBSame
ProcedureSample incubation with micro-well antigen coated plate, followed by a wash step, incubation with an anti-human IgG enzyme conjugate; wash step, incubation with substrate; then the addition of a stop solution and reading at 450nm.Same
Reported ResultsOD RatioSame
Cut-Off LevelRatio 1.0Same
ItemDevicePredicate
Antigen MixturedsDNA, histones, ribosomal P proteins, nRNP/Sm, Sm, SS-A, SS-B, Scl-70, Jo-1, centromeresdsDNA, histones, SS-A (Ro), SS-B (La), Sm, snRNP/Sm, Scl-70, Jo-1 and centromeric antigens and lysed HEp-2 cells
Calibrators & Controls1 calibrator
2 controls: 1 positive, 1 negative3 controls: 1 positive, 1 cut-off (used for calculation of results), 1 negative
Sample BufferReady for use5x concentrate
Wash Buffer10x concentrate50x concentrate
Stop Solution0.5 M sulphuric acid1 M hydrochloric acid
Sample TypesSerum or plasma (EDTA, Li-heparin, Citrate)Serum
Sample Dilution1:2011:101

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EUROIMMUN

  • K. Standard/Guidance Document Referenced (if applicable):
    Guidance for Industry and FDA Staff: Recommendations for Anti-Nuclear 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 IgG enzyme conjugate reagent is added to each microtiter well. After an additional 30minutes incubation at room temperature, the microtiter wells are again washed 3 times with 300 ul 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 (if/when applicable):

1. Analytical performance:

a. Precision/Reproducibility:

The reproducibility of the test was investigated using sera with different concentrations. Intra-assay reproducibility is based on 20 determinations and interassay 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:

n = 16 - 20ANA Screen ELISA (IgG) Ratio
Sample 1Sample 2Sample 3Sample 4Sample 5Sample 6Sample 7Sample 8
Mean Value (x):0.30.91.12.56.17.40.12.4
Range of Values:0.2 - 0.30.8 - 0.91.0 - 1.22.3 - 2.65.8 - 6.37.1 - 7.70.1 - 0.22.0 - 2.8
Expected Result:NegativeNegativePositivePositivePositivePositiveNegativePositive
% positive:0%0%100%100%100%100%0%100%
% negative:100%100%0%0%0%0%100%0%
Sample 9Sample 10Sample 11Sample 12Sample 13Sample 14Sample 15Sample 16
Mean Value (x):4.31.03.22.25.62.32.24.3
Range of Values:3.9 - 4.60.9 - 1.03.0 - 3.52.0 - 2.54.9 - 6.22.1 - 2.52.0 - 2.54.0 - 4.8
Expected Result:PositivePositivePositivePositivePositivePositivePositivePositive
% positive:100%100%100%100%100%100%100%100%
% negative:0%0%0%0%0%0%0%0%
Sample 17Sample 18Sample 19Sample 20Sample 21Sample 22
Mean Value (x):1.67.42.04.62.08.1
Range of Values:1.4 - 1.86.8 - 7.81.8-2.24.2 - 5.01.9-2.17.4-8.8
Expected Result:PositivePositivePositivePositivePositivePositive

Intra-Assay Reproducibility

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્પાડ EUROIMMI NE

n = 16 - 20ANA Screen ELISA (IgG) Ratio
Sample 1Sample 2Sample 3Sample 4Sample 5Sample 6Sample 7Sample 8
% positive:100%100%100%100%100%100%
% negative:0%0%0%0%0%0%
n = 30ANA Screen ELISA (IgG) Ratio
Sample 1Sample 2Sample 3Sample 4Sample 5Sample 6Sample 7Sample 8
Mean Value (x):0.60.91.12.76.07.60.22.4
Range of Values:0.5 - 0.70.7 - 1.01.0 - 1.22.5 - 3.05.4 - 6.47.2 - 8.00.1 - 0.31.6 - 3.1
Expected Result:NegativeNegativePositivePositivePositivePositiveNegativePositive
% positive:0%0%100%100%100%100%0%100%
% negative:100%100%0%0%0%0%100%0%
Sample 9Sample 10Sample 11Sample 12Sample 13Sample 14Sample 15Sample 16
Mean Value (x):4.11.02.81.74.71.91.74.0
Range of Values:3.3 - 4.90.8 - 1.22.0 - 3.51.1 - 2.24.2 - 5.61.1 - 3.31.1 - 2.23.4 - 4.8
Expected Result:PositivePositivePositivePositivePositivePositivePositivePositive
% positive:100%100%100%100%100%100%100%100%
% negative:0%0%0%0%0%0%0%0%
Sample 17Sample 18Sample 19Sample 20Sample 21Sample 22
Mean Value (x):1.46.92.35.22.18.5
Range of Values:1.1 - 2.05.7 - 8.01.6 - 2.73.0 - 6.61.8 - 2.66.9 - 9.8
Expected Result:PositivePositivePositivePositivePositivePositive
% positive:100%100%100%100%100%100%
% negative:0%0%0%0%0%0%

Inter-Assay Reproducibility

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:

*3 lots x 2 runsANA Screen ELISA (IgG) Ratio
** n lots x 1 run
Sample 1Sample 2Sample 3Sample 4Sample 5Sample 6Sample 7Sample 8
n:11**11**11**6*6*6*6*6*
Mean Value (x):0.152.97.10.22.13.71.13.1
Range of Values:0.1-2.02.7-3.26.8-7.80.1-0.21.9-2.43.4-4.31.0-1.23.0-3.2
Expected Result:negativepositivepositivenegativepositivepositivepositivepositive
% positive:0%100%100%0%100%100%100%100%
% negative:100%0%0%100%0%0%0%0%
Sample 9Sample 10Sample 11Sample 12Sample 13Sample 14Sample 15Sample 16
n:6*6*6*6*6*6*6*6*
Mean Value (x):2.04.82.32.03.91.56.02.0
Range of Values:1.5-2.34.4-5.71.9-2.71.5-2.23.7-4.21.4-1.55.3-7.41.9-2.1
Expected Result:positivepositivepositivepositivepositivepositivepositivepositive
% positive:100%100%100%100%100%100%100%100%
% negative:0%0%0%0%0%0%0%0%
Sample 17Sample 18Sample 19
n:6*6*6*
Mean Value (x):6.01.98.5
Range of Values:4.4-6.81.8-2.08.1-8.7
Expected Result:positivepositivepositive
% positive:100%100%100%

Lot to Lot Reproducibility

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| *3 lots x 2 runs

** n lots x 1 runANA Screen ELISA (IgG) Ratio
Sample 1Sample 2Sample 3Sample 4Sample 5Sample 6Sample 7Sample 8
% negative:0%0%0%

  • b. Linearity/assay reportable range:
    Not applicable.

  • c. High Dose Hook Effect
    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 ANA Screen ELISA (IgG) eliminates the adverse contribution of binding proteins, endogenous interfering substances and general matrix effects due to the extra wash step.

  • d. 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 ANA Screen ELISA (IgG) was verified using the CDC ANA reference panel.

  • Detection limit: e.
    Not applicable.

  • Analytical specificity: f.
    Cross-reactivity: The quality of the antigen mixture coated on the plates (containing the antigens nRNP/Sm, Sm, SS-A, SS-B, Scl-70, Jo-1, dsDNA, histones, ribosomal P-proteins and centromeres) ensures a high specificity of the ELISA. 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 ANA Screen 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 0.5 - 7.3) 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

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EÜROIMMUN ====================================================================================================================================================================

92 - 107 %. No significant interference was observed for concentrations of up to 1000 mg/dl for hemoglobin, 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 100 - 110%. No interference was observed with rheumatoid factor up to 500 IU/ml.

  • Assay cut-off: f.
    Ratio 1.0

    1. Comparison studies:
    • Method comparison with predicate device: a.

A comparison study was performed using 158 clinically characterized samples from patients (49 MCTD, 37 systemic lupus erythematosus, 37 Sjögren's syndrome, 19 systemic sclerosis, 16 myositis) and 132 from control groups (10 celiac disease, 17 Wegener's granulomatosis, 39 rheumatoid arthritis, 16 infectious disease and 50 healthy), obtained from different sources. The panel consisted of 101 men and 174 women (and 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 ANA Screen ELISA (IgG) and with the Aesku Aeskulisa ANA Hep-2 as the predicate device. The results are shown in the table below. The discrepant samples were from controls and one MCTD sample in the cut-off range.

n = 290
Predicate ELISA
positivenegative
EUROIMMUN
ANA Screen ELISA
(IgG)positive1373
negative5145
Negative Agreement145/148=98.0%95% C.I.:94.2%-99.6%
Positive Agreement137/142=96.5%95% C.I.:92.0%-98.8%
Overall Agreement282/290=97.2%95% C.I.:94.6%-98.8%
  • Matrix comparison: b.
    The usability of plasma was investigated using sample pairs each of serum and corresponding plasma (EDTA, Li-heparin, Citrate). Passing-Bablok regression was calculated for the comparison of serum to plasma. The regression equation is near the ideal correlation (intercept 0; slope 1.0) indicating equivalence of concentrations between serum and the corresponding plasma matrices. Coefficients of determination were found to be above 0.99 and %recovery compared to serum was in the range of 90 to 112 % (serum = 100 %).

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EDTA plasmaLi-heparin plasmaCitrate plasma
n121212
Regression Equation: (y = plasma, x = serum)y = 0.04 + 0.99 xy = -0.04 + 1.00 xy = -0.00 + 0.99 x
95% C.I. of intercept-0.02 - 0.13-0.10 - 0.01-0.02 - 0.05
95% C.I. of slope0.96 - 1.020.98 - 1.030.95 - 1.00
Coefficient of determination R20.99880.99920.9990
Mean %recovery103 %99 %98 %
Range of %recovery98 - 112 %90 - 109 %95 - 104 %

3. Clinical studies:

a. Clinical Sensitivity:

Clinical studies were performed in cooperation with different sites. In total 738 clinically characterized samples were investigated for anti-nuclear antibodies (IgG). The EUROIMMUN ANA Screen ELISA (IgG) showed an overall sensitivity of 72.5% (95% C.I.: 68.0 - 76.7%) and a specificity of 95.8% (95% C.I.: 92.9 - 97.7%). The results are shown in the table below. 95% C.I. are calculated by the exact method.

No.Panelnpositive%95% C.I.
1Mixed connective tissue diseases212095.2%76.2 - 99.9%
2Systemic lupus erythematosus21315673.2%66.8 - 79.1%
3Poly-/dermatomyositis26415.4%4.4 - 34.9%
4Systemic sclerosis815972.8%61.8-82.1%
5Sjögren's syndrome887281.8%72.2 - 89.2%
Total42931172.5%68.0 – 76.7%
  • Clinical specificity: b.
    .
No.PanelnANA Screen ELISA (IgG)
negative%95% C.I.
6Celiac disease1010100.0%69.2-100.0%
7Wegener's granulomatosis171694.1%71.3-99.9%
8Rheumatoid arthritis20319194.1%89.9-96.9%
9Other autoimmune diseases*6363100.0%94.3 -100.0%
10Bacterial/viral infections1616100.0%79.4-100.0%
Total30929695.8%92.9-97.7%

*from the following groups: AlH (n = 8), PBC (n = 9), Grave's disease (n = 12), Hashimoto (n = 11), celiac disease (n = 11), Diabetes Type I (n = 12)

  • c. Other clinical supportive data (when a. and b. are not applicable):

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Not applicable.

    1. Clinical cut-off:
      See Assay Cut-Off.

5. Expected values/Reference range:

The levels of ANA (IgG) were analyzed in a panel of 200 samples from apparently healthy blood donors (120 men and 80 women with an average age of 40 y; age range: 19 - 68 y). The results are shown in the table below.

n200
Positives6
Negatives194
Prevalence3.0%
Ratio
Lowest Value0.1
Highest Value4.5
Mean Value0.2

Proposed Labeling:

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

Conclusion:

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

Michael Locke

Signature

July 15, 2013 Michael Locke/Director of Regulatory Affairs Date Printed Name/Title

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Image /page/9/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three stripes forming 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.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Bambshire Avenue Document Control Center - WO66-G60 Silver Spring, MI) 20993-0002

EUROIMMUN US.INC C/O MR. MICHAEL LOCKE DIRECTOR, REGULATORY AFFAIRS 1100 THE AMERICAN ROAD MORRIS PLAINS NJ 07960

July 15, 2013

Re: K131185

Trade/Device Name: ANA Screen ELISA (IgG) Regulation Number: 21 CFR 862.1660 Regulation Name: Antinuclear Antibody Immunological Test System Regulatory Class: II Product Code: LJM Dated: April 24, 2013 Received: April 26, 2013

Dear Mr. Locke:

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 docs 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 that I by Federal statues and regulations administered by other Federal agencies. You must or any with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); medical device 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 (Scctions 531-542 of the Act); 21 CFR 1000-1050.

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Page 2-Mr. Michael Locke

If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809), please contact 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.hum. 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/ReportalProblem/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/Resources/or You/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

Enclosure

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Indications for Use

510(k) Number (if known): K131185

EUROIMMUN ANA-Screen ELISA (IgG) Device Name:

Indications For Use:

The EUROIMMUN ANA Screen ELISA (IgG) is intended for the qualitative determination of IgG class antibodies against nuclear antigens (mixture of dsDNA, histones, ribosomal P-proteins, rRNP/Sm, Sm, SS-A, SS-B, Scl-70, Jo-1 and centromeres) in human serum and plasma (EDTA, Li-heparin, Citrate). It is used as an aid in the diagnosis of mixed connective tissue diseases (MCTD), systemic lupus erythematosus, Sjögren's syndrome, progressive systemic sclerosis and poly-/dermatomyositis, 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 M. Chan -S

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

K131185 510(k):