EliA M2 is intended for the in vitro semi-quantitative measurement of IgG antibodies directed to M2 in human serum and plasma (heparin, EDTA) to aid in the clinical diagnosis of primary biliary cirrhosis in conjunction with other laboratory and clinical findings. EliA M2 uses the EliA IgG method on the instruments Phadia 100 and Phadia 250.

EliA M2 Positive Control 100 is intended for laboratory use in monitoring the performance of in vitro measurement of M2 antibodies with Phadia 100 using the EliA IgG method.

EliA M2 Positive Control 250 is intended for laboratory use in monitoring the performance of in vitro measurement of M2 antibodies with Phadia 250 using the EliA IgG method.

Device Description

The new device belongs to a fully integrated and automated system for immunodiagnostic testing. It comprises a Fluorescence-Immunoassay test system using EliA single wells as the solid phase and is intended to be performed on the instruments Phadia 100 and Phadia 250.

The conjugate for the EliA IgG method is mouse anti-human IgG beta-galactosidase, which uses 4-Methylumbelliferyl-ßD-Galactoside as substrate.

The total IgG calibration is based on a set of six WHO-standardized IgG Calibrators derived from human serum. They are used to establish an initial calibration curve, which may be used for up to 28 days on additional assays and can be stored by the instrument. Each additional assay includes calibrator (curve) controls that have to recover in defined ranges to ensure that the stored calibration curve is still valid. The Fluorescence-Immunoassay test system includes test-, method-specific and general reagents that are packaged as separate units.

AI/ML Overview

The provided text describes a submission for an in vitro diagnostic device, not an AI/ML-based medical device. Therefore, many of the requested categories related to AI/ML device studies (such as MRMC studies, training set size, expert adjudication, etc.) are not applicable and cannot be extracted from this document.

However, I can extract information regarding acceptance criteria and device performance from the provided text, focusing on the clinical study that supports its intended use.

Here's the information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state numerical acceptance criteria in the form of a table. However, it implies that the device's performance needs to be comparable to the predicate device and show appropriate results with clinically defined sera and normal populations.

Acceptance Criteria (Implied)	Reported Device Performance
Device performance is substantially equivalent to predicate	"In summary, all available data support that the new devices are substantially equivalent to the predicate devices." (Based on comparison study, results with clinically defined sera, and results from apparently healthy subjects)
Appropriate results for clinically defined sera	"results obtained for clinically defined sera" (No specific numerical performance metric is given, but the data is stated to support substantial equivalence.)
Appropriate results for samples from apparently healthy subjects	"results obtained for samples from apparently healthy subjects (normal population)" (No specific numerical performance metric is given, but the data is stated to support substantial equivalence.)

2. Sample size used for the test set and the data provenance

Sample Size: The document does not explicitly state the specific number of samples for the test set used in the comparison study, clinically defined sera, or normal population. It mentions "a data set including results obtained within a comparison study," "results obtained for clinically defined sera," and "results obtained for samples from apparently healthy subjects (normal population)."
Data Provenance: Not specified in terms of country of origin. The study appears to be retrospective, using existing "clinically defined sera" and "samples from apparently healthy subjects."

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. This is an immunoassay, not an AI/ML device requiring expert interpretation of images or other complex data for ground truth establishment. The "ground truth" for this type of device would typically be the clinical diagnosis of primary biliary cirrhosis, likely established by standard clinical criteria, not by individual experts assessing the samples themselves for ground truth.

4. Adjudication method for the test set

Not applicable. This is an immunoassay. The concept of adjudication for a test set typically applies to areas where human interpretation or labeling is involved, such as image analysis.

5. 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

Not applicable. This is an immunoassay, not an AI/ML device, and no human reader interpretation is described.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This refers to the performance of the immunoassay device itself. The study described focuses on the comparison of the new immunoassay device (EliA M2) to a predicate device (Quanta Lite M2 EP (MIT3), INOVA K052262), and its performance with clinically defined sera and healthy subjects. The entire system (reagents, instrument Phadia 100/250, and software for evaluation) constitutes the "standalone" performance of the diagnostic test.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The ground truth for the "clinically defined sera" and "samples from apparently healthy subjects" would be based on the established clinical diagnosis of Primary Biliary Cirrhosis (PBC) for positive cases and the absence of PBC for healthy subjects, determined through a combination of clinical findings and other laboratory tests. The document implies a clinical diagnosis.

8. The sample size for the training set

Not applicable. This is an immunoassay, not an AI/ML device that requires a training set in the conventional sense. The "training" of the device is inherent in its design and calibration, not through data learning.

9. How the ground truth for the training set was established

Not applicable for the same reasons as point 8.

Summary

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Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo consists of the department's name in a circular arrangement around a symbol. The symbol features three stylized human profiles facing right, with flowing lines connecting them.

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

February 13, 2015

PHADIA US, INC. C/O MR. MARTIN R. MANN SENIOR REGULATORY AFFAIRS MANAGER 4169 COMMERCIAL AVENUE PORTAGE, MI 49002

Re: K141375 Trade/Device Name: EliA™ M2 Immunoassay EliA™ M2 Positive Control 100 EliATM M2 Positive Control 250 Regulation Number: 21 CFR §866.5090 Regulation Name: Antimitochondrial antibody immunological test system Regulatory Class: Class II Product Code: DBM Dated: December 22, 2014 Received: December 24, 2014

Dear Mr. Mann:

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

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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 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 contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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 Industry and Consumer Education 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,

Leonthena R. Carrington -A

Leonthena Carrington, MS, MBA, MT (ASCP) Director (Acting) 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) K141375

Device Name

EliA(TM) M2, EliA(TM) M2 Positive Control 100, EliA M2 Positive Control 250

Indications for Use (Describe)

EliA M2 Positive Control 100 is intended for laboratory use in monitoring the performance of in vitro measurement of M2 antibodies with Phadia 100 using the EliA IgG method.

EliA M2 Positive Control 250 is intended for laboratory use in monitoring the performance of in vitro measurement of M2 antibodies with Phadia 250 using the EliA IgG method.

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

_ Over-The-Counter Use (21 CFR 801 Subpart C)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

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A.7. 510(k) Summary of Safety and Effectiveness

This summary of safety and effectiveness information is being submitted in accordance with the requirements of The Safety Medical Devices Act of 1990 (SMDA 1990) and 21 CFR Part 807.92.

Assigned 510(k) Number:	K141375
Date of Summary Preparation:	February 13, 2015
Manufacturer:	Phadia ABRapsgatan 7PP.O. Box 6460SE-751 37 Uppsala, Sweden
510 (k) Contact Person:	Martin MannRegulatory Affairs ManagerPhadia US Inc.4169 Commercial AvenuePortage, Mi 49002, USA+1 (-269-492) -1957 (Phone)+1 (-269-492) -7541 (Fax)martin.mann@thermofisher.com
Device Name:	EliA™ M2 ImmunoassayEliA™ M2 Positive Control 100EliA™ M2 Positive Control 250
Common Name:	Antimitochondrial antibody immunological test system

Classification

Product Name	Product Code	Class	CFR
EliA™ M2	DBM	II	866.5090
EliA™ M2 Positive Control	JJY	I	862.1660

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Substantial Equivalence to

Quanta Lite M2 EP (MIT3), INOVA

K052262

Intended Use Statements of the New Devices

EliA M2 is intended for the in vitro semi-quantitative measurement of IgG antibodies directed to M2 in human serum and plasma (heparin, EDTA) to aid in the clinical diagnosis of primary biliary cirrhosis in conjunction with other laboratory and clinical findings. EliA M2 uses the EliA IgG method on the instruments Phadia 100 and Phadia 250.
EliA M2 Positive Control 100 is intended for laboratory use in monitoring the performance of in vitro measurement of M2 antibodies with Phadia 100 using the EliA IgG method.
EliA M2 Positive Control 250 is intended for laboratory use in monitoring the performance of in vitro measurement of M2 antibodies with Phadia 250 using the EliA IgG method.

Special condition for use statement

The device is for prescription use only.

Special instrument requirements

Phadia® 100/Phadia® 250 are fully automated immunoassay analyzers, which include software for evaluation of test results.

General Description of the New Device

The conjugate for the EliA IgG method is mouse anti-human IgG beta-galactosidase, which uses 4-Methylumbelliferyl-ßD-Galactoside as substrate.

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Test Principle of the New Device

The EliA Wells are coated with the following antigens:

Test	Antigen coated to the wells:
EliA M2	Native pyruvate dehydrogenase complex frommitochondria and recombinant M2-antigen

If present in the patient's specimen, antibodies to these proteins bind to their specific antigen. After washing away non-bound antibodies, enzyme-labeled antibodies against human IgG antibodies (EliA IgG Conjugate) are added to form an antibody-conjugate complex. After incubation, non-bound conjugate is washed away and the bound complex is incubated with a Development Solution. After stopping the reaction, the fluorescence in the reaction mixture is measured. The higher the response value, the more specific IgG is present in the specimen. To evaluate test results, the response for patient samples is compared directly to the response for calibrators.

Device Comparison

The new and the predicate devices both represent non-competitive solid phase ELISAs. The IVDs are used as an aid in the diagnosis of the following diseases:

Disease	Detection of antibodies to
Primary biliary cirrhosis	M2

Laboratory equivalence

The comparability of the predicate devices and new devices is supported by a data set including

· results obtained within a comparison study between new and predicate device
results obtained for clinically defined sera .
· results obtained for samples from apparently healthy subjects (normal population).

In summary, all available data support that the new devices are substantially equivalent to the predicate devices.

Regulation Number and Section

§ 866.5090 Antimitochondrial antibody immunological test system.

(a)
Identification. An antimitochondrial antibody immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the antimitochondrial antibodies in human serum. The measurements aid in the diagnosis of diseases that produce a spectrum of autoantibodies (antibodies produced against the body's own tissue), such as primary biliary cirrhosis (degeneration of liver tissue) and chronic active hepatitis (inflammation of the liver).(b)
Classification. Class II (performance standards).