EliA ß2-Glycoprotein I IgA is intended for the in vitro semi-quantitative measurement of IgA antibodies directed to ß2-Glycoprotein I in human serum and plasma (heparin, EDTA, citrate) to aid in the diagnosis of antiphospholipid syndrome (APS) as well as thrombotic disorders related to systemic lupus erythematosus (SLE) in conjunction with other laboratory and clinical findings. EliA ß2-Glycoprotein 1 IgA uses the EliA IgA method on the instruments Phadia 100 and Phadia 250.

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 IgA method is mouse anti-human IgA beta-galactosidase, which uses 4-Methylumbelliferyl-BD-Galactoside as substrate.

The total IgA calibration is based on a set of six WHO-standardized IgA 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-specific, method-specific and general reagents that are packaged as separate units.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the EliA™ ß2-Glycoprotein I IgA Immunoassay, based on the provided 510(k) summary:

The provided 510(k) summary primarily focuses on establishing "substantial equivalence" to a predicate device for this in vitro diagnostic (IVD) immunoassay, rather than presenting a performance study with detailed acceptance criteria in the manner one might see for an AI/software device or a medical imaging device. The "performance" here relates to how well the new device compares to the predicate and its ability to detect the target antibodies.

1. Table of Acceptance Criteria and the Reported Device Performance

Acceptance Criteria Category	Specific Criteria (Implied/Stated)	Reported Device Performance (Summary)
Substantial Equivalence	Comparability to predicate device (Varelisa ß2-Glycoprotein I IgA Antibodies, K040450)	Supported by data from: - Comparison study between new and predicate device - Results from clinically defined sera - Results from samples of apparently healthy subjects (normal population) Overall Finding: All available data support the new device is substantially equivalent to the predicate device.
Intended Use	Semi-quantitative measurement of IgA antibodies directed to ß2-Glycoprotein I to aid in diagnosis of antiphospholipid syndrome (APS) and thrombotic disorders related to systemic lupus erythematosus (SLE).	The device's performance supports its intended use as described.
Method	Uses EliA IgA method on Phadia 100 and Phadia 250 instruments.	The device is designed to operate with these instruments and methods.
Calibration	IgA calibration based on six WHO-standardized IgA Calibrators; initial calibration curve valid for up to 28 days; includes calibrator (curve) controls with defined recovery ranges.	The system incorporates this calibration method to ensure validity and accuracy.

Explanation of "Acceptance Criteria" for IVDs in a 510(k) context: For an in vitro diagnostic device seeking 510(k) clearance, acceptance criteria often revolve around demonstrating analytical and clinical performance comparable to a legally marketed predicate device. This typically involves studies on precision, accuracy (comparison to a reference method or predicate), linearity, detection limits, interference, and agreement studies for clinical samples. The provided summary is very high-level and only states that data supports equivalence, rather than detailing specific numerical criteria used in those studies (e.g., "agreement rate >90%").

2. Sample Size Used for the Test Set and Data Provenance

The summary does not provide specific sample sizes for the "test set" or explicit data provenance (e.g., country of origin). It generally refers to:

"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)"

This indicates the data was collected retrospectively from various sample sources to facilitate comparison. Without more detail, it's not possible to determine if the samples were prospective.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not provided in the summary. For an IVD, "ground truth" (or clinical truth) for samples used in method comparison or clinical concordance studies would typically be established by combining patient clinical diagnoses (e.g., diagnosed with APS or SLE by a rheumatologist/hematologist) with results from established, often predicate, diagnostic tests. The summary implies "clinically defined sera" were used, meaning these samples had a known clinical status, but the process of establishing that status (e.g., number and qualifications of clinicians) is not detailed.

4. Adjudication Method for the Test Set

This information is not provided in the summary. For IVDs, adjudication isn't typically used in the same way as for imaging devices where multiple readers interpret images. Instead, the "ground truth" for clinical samples is based on a patient's overall clinical presentation and diagnosis, typically accepted as definitive for the study.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for medical imaging AI devices where human readers interpret images. The EliA™ ß2-Glycoprotein I IgA Immunoassay is an in vitro diagnostic (IVD) serological test, not an imaging device, and does not involve human "readers" interpreting results in a way that an MRMC study would be applicable.

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

This refers to the performance of the immunoassay system itself. The device is described as a "fully integrated and automated system for immunodiagnostic testing" and requires operation on the "Phadia 100/Phadia 250" instruments which include "software for evaluation of test results." Therefore, its performance is inherently "standalone" in the sense that the instrument-software system processes the sample and yields a result without direct human interpretation of a raw signal. The comparison studies described are essentially evaluating this standalone performance against the predicate.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The summary implies two types of "ground truth" for the performance studies:

Predicate Device Results: For the "comparison study between new and predicate device," the predicate device's results (Varelisa ß2-Glycoprotein I IgA Antibodies, K040450) would serve as a comparative ground truth.
Clinical Diagnoses: For "clinically defined sera," the ground truth would be the clinical diagnosis of the patient (e.g., presence or absence of APS or SLE-related thrombotic disorders), presumably based on a combination of clinical symptoms, other laboratory findings, and expert physician assessment. The "samples from apparently healthy subjects" provide a "negative" ground truth based on their healthy status.

8. The Sample Size for the Training Set

The summary does not mention a training set in the context of machine learning or AI. This device is an immunoassay, not an AI or machine learning device that requires a separate training phase. The "calibration" of the device is based on a set of WHO-standardized IgA Calibrators, which is distinct from a machine learning training set.

9. How the Ground Truth for the Training Set was Established

As no training set (in the machine learning sense) is discussed, this question is not applicable. The "ground truth" for the calibration is established by using "WHO-standardized IgA Calibrators derived from human serum," implying these calibrators have a known and certified IgA concentration.

Summary

{0}------------------------------------------------

K112414

510(k) Summary of Safety and Effectiveness

JUN 2 2 2012

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:

Date of Summary Preparation: May 29, 2012

Manufacturer:

Phadia AB Rapsgatan 7 SE-751 37 Uppsala, Sweden

510 (k) Contact Person:

Martin Mann Regulatory Affairs Manager Phadia US Inc. 4169 Commercial Avenue Portage, Mi 49002, USA +1 (-269-492) -1957 (Phone) +1 (-269-492) -7541 (Fax) martin.mann@phadia.com

Device Name:

EliA™ ß2-Glycoprotein I IgA Immunoassay

Common Name:

B2-Glycoprotein I autoantibody immunological test system

Classification

Product Name	Product Code	Class	CFR
EliA β2-Glycoprotein I IgA	MSV	II	866.5660

{1}------------------------------------------------

Substantial Equivalence to

Varelisa ß2-Glycoprotein I IgA Antibodies

K040450

Intended Use Statement of the New Device

{2}------------------------------------------------

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 IgA method is mouse anti-human IgA beta-galactosidase, which uses 4-Methylumbelliferyl-BD-Galactoside as substrate.

Test Principle of the New Device

The EliA Wells are coated with the following antigen:

Test	Antigen coated to the wells:
EliA β2-Glycoprotein I IgA Well	Human β2-Glycoprotein I antigen

If present in the patient's specimen, antibodies to the antigen mentioned above bind to their specific antigen. After washing away non-bound antibodies, enzyme-labeled antibodies against human IgA antibodies (EliA IgA 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 higher the amount of antibody bound and detected in the sample tested. To evaluate test results, the response for patient samples is compared directly to the response for calibrators.

{3}------------------------------------------------

Device Comparison

The new and the predicate device both represent non-competitive solid phase ELISAs. Both IVDs are used as an aid in the diagnosis of antiphospholipid syndrome (APS) and to evaluate the thrombotic risk in patients with systemic lupus erythematosus (SLE).

Laboratory equivalence

The comparability of predicate device and new device 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 device is substantially equivalent to the predicate device.

{4}------------------------------------------------

Image /page/4/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.

Food and Drug Administration

10903 New Hampshire Avenue Silver Spring, MD 20993

Phadia AB c/o Martin Mann Regulatory Affairs Manager 4169 Commercial Avenue Portage, MI 49002, USA

JUN 2 2 2012

Re: K112414

Trade/Device Name: EliA™ ß2-Glycoprotein I IgA Immunoassay Regulation Number: 21 CFR §866.5660 Regulation Name: Multiple autoantibodies immunological test system Regulatory Class: Class II Product Code: MSV Dated: June 20, 2012 Received: June 21, 2012

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). and Cosmetic Pro (110) 1100 (110) 1100) 110 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 n your device is elabilities 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 I lease be advised that I Dr. interestion that your device complies with other requirements of the Act that I Drimas intatutes and regulations administered by other Federal agencies. You must of uny I outral 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 CI K Par 807), laboration adverse events) (21 CFR 803); and good manufacturing practice medical device related adverted on the quality systems (QS) regulation (21 CFR Part 820). This letter requirements as bet formarketing your device as described in your Section 510(k) premarket

{5}------------------------------------------------

Page 2 - Mr. Martin Mann

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,

Reena Philip

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

Enclosure

{6}------------------------------------------------

Indications for Use

510(k) Number (if known):

k 112414

Device Name:

EliA™ ß2-Glycoprotein I IgA

Indications For Use:

EliA ß2-Glycoprotein I IgA is intended for the in vitro semi-quantitative measurement of IgA antibodies directed to B2-Glycoprotein I in human serum and plasma (heparin, EDTA, citrate) to aid in the diagnosis of antiphospholipid syndrome (APS) as well as thrombotic disorders related to systemic lupus erythematosus (SLE) in conjunction with other laboratory and clinical findings. EliA ß2-Glycoprotein I IgA uses the EliA IgA method on the instruments Phadia 100 and Phadia 250.

Prescription Use V (21 CFR Part 801 Subpart D) And/Or

Over the Counter Use (21 CFR Part 801 Subpart C)

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

Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)

Riene Philip

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) k 1/24/14

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).