The EUROIMMUN Anti-LKM-1 ELISA (IgG) test kit is intended for the qualitative detection of IgG class autoantibodies against LKM-1 (cytochrome P450 IID6 of liver-kidney-microsomes) in human serum and plasma. It is used as an aid in the diagnosis of autoimmune hepatitis, type 2, in conjunction with other laboratory and clinical findings.

Device Description

The EUROIMMUN Anti-LKM-1 ELISA (IgG) consists of a microwell ELISA plate coated with LKM-1 antigen, 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

Here's a summary of the acceptance criteria and study details for the EUROIMMUN Anti-LKM-1 ELISA (IgG) device, based on the provided text:

Acceptance Criteria and Device Performance

Parameter	Acceptance Criteria (Implicit)	Reported Device Performance
Intended Use	Qualitative detection of IgG class autoantibodies against LKM-1 as an aid in diagnosing autoimmune hepatitis, type 2.	Same as intended use.
Predicate Device	Substantial equivalence to Inova Quanta Lite LKM-1 ELISA (K000535).	The new device is substantially equivalent to the predicate device, sharing similar intended use, technology (ELISA), assay platform (96-well microtiter plates), assay format (qualitative), calibration (relative), antigen (recombinant cytochrome P450 IID6), substrate (TMB), reagent preparation, and procedure. Minor differences exist in conjugate, calibrators/controls, wash buffer concentration, stop solution concentration, sample types (plasma included for new device), reported results (ratio vs. units), and cut-off level. A method comparison study with the predicate device showed a negative agreement of 96.9% (95% C.I.: 92.9% - 99.0%), a positive agreement of 97.2% (95% C.I.: 85.5% - 99.9%), and overall agreement of 96.9% (95% C.I.: 93.5% - 98.9%).
Precision	Sufficient intra-assay and inter-assay reproducibility, with no positive samples found negative and vice-versa (with minor exceptions near cutoff).	Intra-Assay Reproducibility (n=20): Sample 1 (negative): 100% negative; Sample 2 (negative): 100% negative; Sample 3 (positive): 100% positive; Sample 4 (positive): 100% positive; Sample 5 (positive): 100% positive; Sample 6 (positive): 100% positive.
		Inter-Assay Reproducibility (n=24): Sample 1 (negative): 100% negative; Sample 2 (negative): 96% negative (4% positive, likely single determination near cutoff); Sample 3 (positive): 100% positive; Sample 4 (positive): 100% positive; Sample 5 (positive): 100% positive; Sample 6 (positive): 100% positive.
		Lot-to-Lot Reproducibility: Sufficient, with no positive sample found negative and vice versa. Examples shown for 11 samples over different 'n' values: positives remained 100% positive, negatives remained 100% negative.
Analytical Specificity	No significant cross-reactivity with antibodies against SLA/LP, and no significant interference from common substances (hemoglobin, triglycerides, bilirubin).	Cross-reactivity: 28 sera positive for SLA/LP were all negative in the Anti-LKM-1 ELISA (IgG). Interference: Recovery between 86-126% for samples spiked with hemoglobin (up to 1000 mg/dL), triglycerides (up to 2000 mg/dL), and bilirubin (up to 40 mg/dL). No significant interference observed.
Clinical Sensitivity	High sensitivity for AIH type 2.	For Autoimmune hepatitis type 2 (AIH-2): 95.6% (95% C.I.: 87.6 - 99.1%)
Clinical Specificity	High specificity against various control groups (AIH/PBC overlap, AIH-1, viral hepatitis, toxic liver damages, steatohepatitis, PBC, PSC, other autoimmune diseases).	For various control groups (AIH/PBC overlap, AIH-1, viral hepatitis, toxic liver damages, steatohepatitis, PBC, PSC, other autoimmune diseases): 100.0% (95% C.I.: 99.2 - 100.0% total specificity for these combined groups). Specificity for each individual control group was 100%.
Matrix Comparison	Equivalence of concentration between serum and corresponding plasma matrices (EDTA, Heparin, Citrate).	Passing-Bablok regression showed: EDTA plasma (y = 0.02 + 1.00 x, 95% C.I. of intercept: -0.04 to 0.06, 95% C.I. of slope: 0.98 to 1.02); Heparin plasma (y = -0.00 + 1.00 x, 95% C.I. of intercept: -0.03 to 0.06, 95% C.I. of slope: 0.97 to 1.01); Citrate plasma (y = 0.00 + 0.97 x, 95% C.I. of intercept: -0.06 to 0.05, 95% C.I. of slope: 0.95 to 1.00). All comparisons satisfied the condition for equivalence (95% C.I. of slope contains 1.0, and 95% C.I. of intercept contains 0). Coefficients of determination were >0.99 and %BIAS from serum was 87-109%.
Expected Values in Healthy Blood Donors	Characterization of results in a healthy population.	In a panel of 150 healthy blood donors, with a cut-off of ratio 1.0, only one was positive. Negatives: 149, Positives: 1. Mean value: Ratio 0.2.

Study Details

Sample sizes used for the test set and the data provenance:
- Method Comparison with Predicate Device:
  - Sample Size: 196 total samples (167 initial samples + 29 additional samples created by mixing positive and negative samples).
  - Provenance: "A study was performed in cooperation with a university clinical hospital". Country of origin is not specified, but the context implies it's likely within the same regulatory region as the applicant (EUROIMMUN US INC.), possibly the US or Europe. The study type appears to be retrospective, using a pre-existing collection of samples from different patient groups.
  - Sample Breakdown: 58 from AIH patients, 66 from PBC patients, 15 from AIH/PBC overlap syndrome patients, and 28 from patients with viral hepatitis. 30 men and 137 women, age 1-87 years (average 50 years).
- Matrix Comparison:
  - Sample Size: 16 sample pairs (serum and corresponding plasma for EDTA, Heparin, and Citrate plasma).
  - Provenance: Not explicitly stated, but likely from a laboratory setting as part of an analytical validation. Retrospective.
- Clinical Studies (Sensitivity and Specificity):
  - Sample Size: 515 clinically characterized samples.
  - Provenance: "Performed in cooperation with several university, hospital and private laboratories". Country of origin not specified, but likely multi-center. Retrospective.
  - Sample Breakdown: 68 from AIH-2 patients, 65 from AIH-1 patients, 15 from AIH/PBC overlap syndrome patients, and 367 from other control groups (Viral hepatitis, Toxic liver damages, Steatohepatitis, PBC, PSC, Other autoimmune diseases: MCTD, celiac disease, Diabetes Type I, Hashimoto, Grave's disease, ulcerative colitis).
- Expected Values/Reference Range:
  - Sample Size: 150 apparently healthy blood donors.
  - Provenance: Not explicitly stated, but implies a collection from a healthy population. Retrospective.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- The document does not specify the number of experts or their qualifications. The clinical samples were "clinically characterized" and categorized as originating "from AIH-2 patients," "AIH-1 patients," etc., suggesting diagnoses were established by medical professionals, but details about the consensus process or individual qualifications are not provided.
Adjudication method for the test set:
- No explicit adjudication method (e.g., 2+1, 3+1) is mentioned for establishing the ground truth diagnoses. The samples were simply described as "clinically characterized," implying standard clinical diagnostic procedures were followed.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done:
- No, an MRMC comparative effectiveness study was not done. This device is an ELISA kit for detecting autoantibodies, not an imaging device or one that involves human interpretation of output that would typically be assessed in an MRMC study.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Yes, the performance data presented (precision, analytical specificity, clinical sensitivity, clinical specificity) represent the standalone performance of the ELISA kit itself. The output of the ELISA is a quantitative ratio, which is then interpreted against a fixed cut-off (Ratio 1.0) to yield a qualitative (positive/negative) result. This process does not involve a human "in-the-loop" for the interpretation of the direct output of the device beyond reading the final calculated ratio.
The type of ground truth used:
- Clinical Diagnosis: For the clinical sensitivity and specificity studies, the ground truth was established by "clinically characterized samples" from specific patient groups (e.g., "Autoimmune hepatitis type 2 (AIH-2) patients," "Viral hepatitis," "Primary biliary liver cirrhosis (PBC)"). This implies a ground truth based on established clinical diagnostic criteria, likely involving a combination of clinical findings, histology, and other laboratory tests.
- Predicate Device/Reference Method: For the method comparison study, the predicate device (Inova Quanta Lite LKM-1 ELISA) served as a reference method for comparison.
- Serological Status: For cross-reactivity, ground truth was based on samples "serologically positive for antibodies against SLA/LP."
The sample size for the training set:
- The document does not specify a separate "training set" for the ELISA device. ELISA assays are typically developed based on biochemical principles and optimized through analytical validation, rather than being "trained" in the same way machine learning algorithms are. The samples described in the performance characteristics section are for validation and verification of the device's analytical and clinical performance.
How the ground truth for the training set was established:
- As there's no explicitly defined "training set" in the context of machine learning for this ELISA device, this question is not directly applicable. The development and optimization of the ELISA kit would involve extensive laboratory work, antigen selection, and reagent formulation, with performance evaluated against characterized clinical samples as described in the "Test Set" details.

Summary

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EUROIMMUN US INC.

ATTACHMENT 1

SEP 11 2012

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

A. 510(k)Number: K112223
B. Purpose for Submission: New device
C. Measurand: Anti-LKM-1 autoantibodies
D. Type of Test: Qualitative enzyme immunoassay
E. Applicant: EUROIMMUN US INC.
F. Proprietary and Established Names: EUROIMMUN Anti-LKM-1 ELISA (IgG)
G. Regulatory Information:
- Regulation: 1.
  - 21 CFR 866.5660 Multiple autoantibodies immunological test system
- Classification: 2. Class II
- 1. Product code:
- NBS .
- র্ব . Panel:
  - Immunology

H. Intended Use:

Intended use(s): 1.
The EUROIMMUN Anti-LKM-1 ELISA (IgG) test kit is intended for the qualitative detection of IgG class autoantibodies against LKM-1 (cytochrome P450 IID6 of liver-kidney-microsomes) in human serum and plasma. It is used as an aid in the diagnosis of autoimmune hepatitis, type 2, in conjunction with other laboratory and clinical findings.
Indication(s) for use: 2.
- Same as intended use.
1. Special conditions for the use statement(s): For prescription use only.
Special instrument requirements: বা

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

l. Device Description:

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Substantial Equivalence Information: J.

Predicate device name (s): 1. Inova Quanta Lite LKM-1 ELISA
1. Predicate 510(k) number(s): K000535
1. Comparison with predicate:

Similarities
Item	New Device	Predicate Device
Intended use	Detection of IgG antibodies to LKM-1 as an aid indiagnosis of autoimmune hepatitis.	Same
Technology	ELISA	Same
Assay platform	96-well microtiter plates	Same
Assay format	Qualitative	Same
Calibration	Relative	Same
Antigen	Recombinant cytochrome P450 IID6.	Same
Substrate	TMB	Same
Reagent preparation	All reagents, calibrator and controls are ready touse, except for the wash buffer.	Same
Procedure	Sample incubation with micro-well antigen coatedplate, followed by a wash step, incubation with ananti-human IgG enzyme conjugate; wash step,incubation with substrate; then the addition of astop solution and reading at 450nm.	Same
Differences
Item	New Device	Predicate Device
Conjugate	Rabbit anti-human IgG labeled with horseradishperoxidase	Goat anti-human IgG labeled with horseradishperoxidase
Calibrators and controls	1 calibrator2 controls1 positive, 1 negative	3 controls1 high positive, 1 low positive, 1 negative
Wash buffer	10x concentrate	40x concentrate
Stop solution	0.5 M sulphuric acid	0.344 M sulphuric acid
Sample types and dilution	Serum or plasma1:101 dilution	Serum1:101 dilution
Reported results	Ratio	Units
Cut off level	Ratio 1.0	25 Units

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

None referenced.

L. Test Principle:

Patient samples are diluted 1:101 in sample buffer, 100 µl of each diluted patient sample and pre-diluted controls and calibrator are added to the antigen 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 ul of the anti-human IgG 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 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 µl 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.

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Performance Characteristics (where applicable): M.

Analytical performance: 1.
- a. Precision/Reproducibility:

The reproducibility of the test was investigated with samples at different points on the calibration curve. Intra-assav reproducibility is based on 20 determinations and inter-assay reproducibility on 24 determinations performed in 6 different runs (days) according to the package insert. Both intra-assay and inter-assay reproducibility were found to be sufficient as no positive sample was found negative and vice versa (except for a single determination of a negative sample that was very close to the cutoff). The following results were obtained:

Intra-assav reproducibility

n = 20	Anti-LKM-1 ELISA (IgG)Ratio
	Sample 1	Sample 2	Sample 3	Sample 4	Sample 5	Sample 6
Mean value (x):	0.2	0.8	1.2	1.9	3.0	4.7
Range of values:	0.2 – 0.2	0.7 - 0.8	1.1 – 1.3	1.8 – 2.0	2.9 – 3.2	4.1 – 5.0
Expected result:	negative	negative	positive	positive	positive	positive
% positive:	0%	0%	100%	100%	100%	100%
% negative:	100%	100%	0%	0%	0%	0%

Inter-assay reproducibility

n = 24	Anti-LKM-1 ELISA (IgG) Ratio
	Sample 1	Sample 2	Sample 3	Sample 4	Sample 5	Sample 6
Mean value (x):	0.2	0.8	1.2	1.9	2.9	4.6
Range of values:	0.2 - 0.3	0.7 - 1.0	1.0 - 1.3	1.5 - 2.2	2.4 - 3.4	3.9 - 5.2
Expected result:	negative	negative	positive	positive	positive	positive
% positive:	0%	4%	100%	100%	100%	100%
% negative:	100%	96%	0%	0%	0%	0%

The Lot to Lot reproducibility was investigated during the validaton and quality control of the kit using different lots with QC samples distributed over the measurement range. Lot to lot reproducibility was found to be sufficient as no positive sample was found negative and vice versa. The following results were obtained:

		Anti-LKM-1 ELISA (IgG)
		Ratio
Sample	Sample 1	Sample 2	Sample 3	Sample 4	Sample 5	Sample 6	Sample 7
n	6	6	6	6	6	6	6
Mean value (x):	0.9	1.2	1.7	2.4	2.9	4.8	5.8
Range of values:	0.9 - 0.9	1.2 - 1.4	1.6 - 1.8	2.3 - 2.5	2.8 - 3.0	4.5 - 5.1	5.7 - 6.0
Expected result:	negative	positive	positive	positive	positive	positive	positive
% positive:	0%	100%	100%	100%	100%	100%	100%
% negative:	100%	0%	0%	0%	0%	0%	0%
Sample	Sample 8	Sample 9	Sample 10	Sample 11
n	32	7	14	8
Mean value (x):	7.3	8.0	0.1	0.1
Range of values:	5.5 - 8.3	7.2 - 8.7	0.1 - 0.1	0.1 - 0.2
Expected result:	positive	positive	negative	negative
% positive:	100%	100%	0%	0%
% negative:	0%	0%	100%	100%

Lot to lot reproducibility

3 lots x 2 runs n lots x 1 run

b. Linearity/assay reportable range:

Not applicable.

Traceability, Stability, Expected values (controls, calibrators or methods): C.
There is no recognized standard or reference material for antibodies. Results are given as ratios.

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ರ. Detection limit:
Not applicable.
Analytical specificity: ର.
Cross-reactivity: Cross reactivity was investigated using a panel of 28 sera serologically positive for antibodies against SLA/LP. All 28 sera were negative in the Anti-LKM-1 ELISA (IgG), so no cross reactivity is expected.

Interference: To investigate the influence from hemoglobin, triglycerides and bilirubin, 5 different specimens at different anti-LKM-1 concentrations (ratio 1.1 - 9.3) 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 was within the range of 86 - 126%. No significant interference was observed for concentrations of up to 1000 mg/d for hemoglobin, 2000 mg/dl for triglyceride and 40 mg/dl for bilirubin.

f. Assay cut-off:
Ratio 1.0

2. Comparison studies:

Method comparison with predicate device: a.
A study was performed in cooperation with a university clinical hospital comparing the performance of the EUROIMMUN Anti-LKM-1 ELISA (IgG) and an FDA released predicate device. 167 samples were investigated (58 from AIH patients, 66 from PBC patients, 15 from patients with AIH/PBC overlap syndrome and 28 from patients with viral hepatitis). The panel consisted of 30 men and 137 women. Age ranged from 1 to 87 years with an average age of 50 years. To cover the lower range with more samples, additional 29 samples were created by mixing of positive and negative samples.

n = 196			Predicate ELISA
	positive	borderline	negative
EUROIMMUNAnti-SLA/LP ELISA (IgG)	positive	35	0	5
	negative	1	0	155
Negative agreement	155 / 160 =	96.9%	95% C.I.:	92.9% - 99.0%
Positive agreement	35 / 36 =	97.2%	95% C.I.:	85.5% - 99.9%
Overall agreement	190 / 196 =	96.9%	95% C.I.:	93.5% - 98.9%

Matrix comparison: b.
The usability of plasma was investigated using 16 sample pairs each of serum and corresponding plasma. The samples cover concentrations in the diagnostically important range and the cut-off. Passing-Bablok regression was calculated for the comparison of serum to plasma. The results are shown in the table below.

	EDTA plasma	Heparin plasma	Citrate plasma
Regression equation(y = plasma, x = serum)	$y = 0.02 + 1.00 x$	$y = -0.00 + 1.00 x$	$y = 0.00 + 0.97$
95% C.I. of intercept	-0.04 to 0.06	-0.03 to 0.06	-0.06 to 0.05
95% C.I. of slope	0.98 to 1.02	0.97 to 1.01	0.95 to 1.00

A comparison in which the 95% C.I. of the slope contains 1.0 and the 95% C.I. of the intercept contains 0 indicates equivalence of concentration between serum and the corresponding plasma matrices. The comparison above satisfies this condition.

Coefficients of determination were found to be above 0.99 and %BIAS from serum was in the range of 87 to 109 % (serum = 100 %).

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3. Clinical studies:

In a clinical/diagnostical study, performed in cooperation with several university, hospital and private laboratories, in total 515 clinically characterized samples (68 from AIH-2 patients, 65 from AIH-1 patients, 15 from patients with AIH/PBC overlap syndrome and 367 from other control groups) were investigated for anti-UKM-1 antibodies (IgG). The EUROIMMUN Anti-LKM-1 ELISA (IgG) showed a sensitivity for AlH type 2 of 95.6% (95% C.I.: 87.6 - 99.1%). The specificity was 100.0% (95% C.I.: 99.2 - 100.0%).

Clinical sensitivity: a.

No.	Panel	n	Anti-LKM-1 ELISA (IgG)
			positive	%	95% C.I.
1	Autoimmune hepatitis type 2 (AIH-2)	68	65	95.6%	87.6 – 99.1%

b. Clinical specificity:

No.	Panel	n	negative	%	95% C.I.
2	AIH/PBC overlap syndrome	15	15	100.0%	78.2 - 100.0%
3	Autoimmune hepatitis type 1 (AIH-1)	65	65	100.0%	94.5 - 100.0%
4	Viral hepatitis	118	118	100.0%	96.9 - 100.0%
5	Toxic liver damages	14	14	100.0%	76.8 - 100.0%
6	Steatohepatitis	24	24	100.0%	85.8 - 100.0%
7	Primary biliary liver cirrhosis (PBC)	111	111	100.0%	96.7 - 100.0%
8	Primary sclerosing cholangiitis (PSC)	19	19	100.0%	82.4 - 100.0%
9	Other autoimmune diseases*	81	81	100.0%	95.5 - 100.0%
	Total	447	447	100.0%	99.2 - 100.0%

*from the following groups: MCTD (n = 20), celiac disease (n = 11), Diabetes Type I (n = 12), Hashimoto (n = 11), Grave's disease (n = 12), ulcerative colitis (n = 15)

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

Clinical cut-off:

See Assay cut-off.

1. Expected values/Reference range:
  The levels of anti-LKM-1 antibodies (IgG) were analyzed with the EUROIMMUN Anti-LKM-1 ELISA (IgG) in a panel of 150 apparently healthy blood donors (mixed age and sex). With a cut-off of ratio 1.0, only one blood donor was found positive.

Positives	1
Negatives	149
Lowest value	Ratio 0.0
Highest value	Ratio 3.4
Mean value	Ratio 0.2
Std dev. (SD)	Ratio 2.29
95th percentile	0.4
99th percentile	0.8

N. Proposed Labeling:

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

o. Conclusion:

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

Date

Signature

Kathryn Kohl, Managing Director Typed Name, Title

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized representation of an eagle or other bird, with its wings spread.

Food and Drug Administration

10903 New Hampshire Avenue Silver Spring, MD 20993

SEP 1 1 2012

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

Re: K112223

Trade/Device Name: EUROIMMUN Anti-LKM-1 (IgG) Regulation Number: 21 CFR 866.5660 Regulation Name: Multiple autoantibodies immunological test system Regulatory Class: Class II Product Code: NBS Dated: September 5, 2012 Received: September 7, 2012

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.

If your device is classified (see above) into class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); medical device reporting (reporting of

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Page 2 – Ms. Kathryn Kohl

medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). 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 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 advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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/cdrh/industry/support/index.html.

Sincerely yours,

ﮯ ﮨﯿﮟ ﺍﻭﺭ ﺍﺱ ﮐﮯ ﺍﺱ ﮐﮯ ﺍﺱ ﮐﮯ ﺍﺱ ﮐﮯ ﺍﺱ ﮐﮯ ﺍﺱ ﮐﮯ ﺍﺱ ﮐﮯ ﺍﺱ ﮐﮯ ﺍﺱ ﮐﮯ ﺍﺱ ﮐﮯ ﺍﺱ ﮐﮯ ﺍﺱ ﮐﮯ ﺍﺱ ﮐﮯ ﺍﺱ ﮐﮯ ﺍﺱ ﮐﮯ ﺍﺱ ﮐﮯ ﺍﺱ ﮐﮯ ﺍﺱ ﮐﮯ ﺍﺱ ﮐﮯ ﺍﺱ ﮐﮯ ﺍﺱ ﮐﮯ ﺍﺱ ﮐﮯ ﺍﺱ ﮐﮯ ﺍﺱ ﮐﮯ ﺍﺱ ﮐﮯ ﺍﺱ ﮐﮯ ﺍﺱ ﮐﮯ ﺍ

Reena Philip

Maria Chan, Ph.D. Director Division of Immunology and Hematology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): K112223

Anti-LKM-1 ELISA (IgG) Device Name:

Indications For Use:

The EUROIMMUN Anti-LKM-1 ELISA (IgG) test kit is intended for the qualitative detection of IgG class autoantibodies against LKM-1 (cytochrome P450 IID6 of liverkidney-microsomes) in human serum and plasma. It is used as an aid in the diagnosis of autoimmune hepatitis, type 2, 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 Diagnostic Devices (OIVD)

Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

510K K112223

Page 1 of

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).