EliA dsDNA is intended for the in vitro quantitative measurement of IgG antibodies directed to dsDNA in human serum and plasma (heparin, EDTA, citrate) as an aid in the clinical diagnosis of systemic lupus erythematosus (SLE) in conjunction with other laboratory and clinical findings. EliA dsDNA Immunoassav uses the EliA IgG method on the instrument ImmunoCAP 100 and ImmunoCAP 250.

EliA ANA Control is intended for laboratory use in monitoring the performance of in vitro measurement of antinuclear antibodies (ANA) with ImmunoCAP 100 or ImmunoCAP 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 ImmunoCAP 100 and ImmunoCAP 250. The conjugate for the EliA IgG method is mouse anti-human IgG beta-galactosidase, which uses 4-Methylumbelliferyl-BD-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 mav 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

This document describes a 510(k) submission for the EliA™ dsDNA Immunoassay and EliA™ ANA Control. The submission focuses on establishing substantial equivalence to a predicate device rather than presenting a study where a device meets specific acceptance criteria. Therefore, many of the requested categories are not applicable to this type of regulatory submission. The document primarily details the intended use, classification, and comparison to a predicate device.

Here's an analysis based on the provided text:

1. A table of acceptance criteria and the reported device performance

This document does not provide a table of acceptance criteria and reported device performance in the traditional sense of a clinical trial demonstrating a device meets a pre-defined performance threshold. Instead, it aims to demonstrate "substantial equivalence" to a predicate device. The performance is assessed through "laboratory equivalence" studies as described below.

2. Sample sized used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

The document mentions "a comparison study between new and predicate device," "results obtained for clinically defined sera," and "results obtained for samples from apparently healthy subjects (normal population)". However, specific sample sizes for these test sets are not provided. The data provenance (country of origin, retrospective/prospective) is also not specified.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

This information is not provided in the document. The "ground truth" here would likely refer to the clinical diagnosis of Systemic Lupus Erythematosus (SLE) for "clinically defined sera". However, details on how these diagnoses were established or by whom are absent.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

This information is not provided as the document does not describe a process involving adjudication of expert opinions for a test set.

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

An MRMC study is not applicable to this type of in vitro diagnostic device (immunoassay). This is an immunoassay measuring anti-dsDNA antibodies, not an imaging device requiring human interpretation, nor does it incorporate AI.

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

This is an immunoassay, and its performance is inherently "standalone" in the sense that it provides a quantitative measurement. There isn't an "algorithm only" component that would be compared to a human-in-the-loop. The device's performance is its output based on the biological sample.

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

For the "clinically defined sera," the ground truth implicitly stems from a clinical diagnosis of Systemic Lupus Erythematosus (SLE), as the device aids in this diagnosis. For "samples from apparently healthy subjects," the ground truth is their healthy status. However, the exact methodology for establishing these ground truths (e.g., expert consensus based on specific clinical criteria, detailed clinical outcomes) is not explicitly described.

8. The sample size for the training set

This document describes a medical device, not a machine learning model that requires a distinct "training set." Therefore, a separate training set in the AI/ML context is not applicable. The "calibration" of the device is mentioned, which involves a set of six WHO-standardized IgG Calibrators.

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

As there is no "training set" in the context of an AI/ML model, this question is not applicable. The "ground truth" for the device's calibration involves "WHO-standardized IgG Calibrators derived from human serum," implying these calibrators have established, known concentrations of IgG.

Summary

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DEC 07 2007

Image /page/0/Picture/2 description: The image contains a handwritten string of alphanumeric characters. The string appears to be 'K072393'. The characters are written in a simple, slightly irregular style, typical of handwriting.

9. 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: K072393

Date of Summary Preparation: December 3, 2007

Phadia AB Rapsgatan 7 SE-751 37 Uppsala, Sweden

510 (k) Contact Person:	Martin MannRegulatory Affairs ManagerPhadia US Inc.4169 Commercial AvenuePortage, Mi 49002, USA269-492-1957 (Phone)269-492-7541 (Fax)martin.mann@phadia.com
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Device Name:	EliA TM dsDNA ImmunoassayEliATM ANA Control
Common Name:	Anti-dsDNA antibodies immunological

Anti-dsDNA antibodies immunological test system and Control

Classification

Manufacturer:

Product Name	Product Code	Class	CFR
EliA™ dsDNA Immunoassay	LRM	II	866.5100
EliA™ ANA Control	JJY	I	862.1660

Substantial Equivalence to DPC anti-DNA

510(k) number: K874873

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Intended Use Statement of the New Device

EliA ANA Control is intended for laboratory use in monitoring the performance of in vitro measurement of antinuclear antibodies (ANA) with ImmunoCAP 100 or ImmunoCAP 250 using the EliA IgG method.

Special condition for use statement

The device is for prescription use only.

Special instrument requirements

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

General Description of the New Device

Test Principle of the New Device

The EliA dsDNA Wells are coated with double-stranded plasmid DNA. If present in the patient's specimen, antibodies to dsDNA 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

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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 device both are used as an aid in the diagnosis of Systemic Lupus Erythematosus (SLE) in conjunction with other laboratory and clinical findings.

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.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three lines representing 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.

Public Health Service

DEC 0 7 2007

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Phadia US, Inc. c/o Mr. Martin R. Mann Regulatory Affairs Manager 4169 Commercial Ave Portage, MI 49002

Re: K072393 Trade/Device Name: EliATM dsDNA Regulation Number: 21 CFR 866.5100 Regulation Name: Antinuclear autoantibody, antigen and control Regulatory Class: Class II Product Code: LSW, JJY Dated: November 26, 2007 Received: November 27, 2007

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); 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

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Page 2 -

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 information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (240) 276-0450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Thos. T. Beall

Robert L. Becker, Jr., M.L , 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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EliA™ dsDNA - New Device 510(k) Submission Section 1: Indications for Use Statement

Indications for Use

510(k) Number:

K072393

Device Name:

EliA™ dsDNA

Indications For Use:

EliA dsDNA is intended for the in vitro quantitative measurement of IgG antibodies directed to dsDNA in human serum and plasma (heparin, EDTA, citrate) as an aid in the clinical diagnosis of systemic lupus erythematosus (SLE) in conjunction with other laboratory and clinical findings. EliA dsDNA uses the EliA IgG method on the instrument ImmunoCAP 100 and ImmunoCAP 250.

Prescription Use V AND/OR (Part 21 CFR 801 Subpart D)

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

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

Mana M Chan
Division Sign-Off

Concurrence of CDRH, Office of Device Evaluation (ODE)

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K0 72543

CONFIDENTIAL AND PROPRIETARY

Page I

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EliA™ dsDNA – New Device 510(k) Submission Section 1: Indications for Use Statement

Indications for Use

510(k) Number:

K072393

Device Name:

EliA™ ANA Control

Indications For Use:

EliA ANA Control is intended for laboratory use in monitoring the performance of in vitro measurement of antinuclear antibodies (ANA) with ImmunoCAP 100 or ImmunoCAP 250 using the EliA IgG method.

_ AND/OR Prescription Use _ V (Part 21 CFR 801 Subpart D)

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

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

m chon

Concurrence of CDRH, Office of Device Evaluation (ODE Division Sign-C

Office of In Vitro Diagnostic Device Evaluation and So

CONFIDENTIAL AND PROPRIETARY

510(K) [K07259] Page 2

Regulation Number and Section

§ 866.5100 Antinuclear antibody immunological test system.

(a)
Identification. An antinuclear antibody immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the autoimmune antibodies in serum, other body fluids, and tissues that react with cellular nuclear constituents (molecules present in the nucleus of a cell, such as ribonucleic acid, deoxyribonucleic acid, or nuclear proteins). The measurements aid in the diagnosis of systemic lupus erythematosus (a multisystem autoimmune disease in which antibodies attack the victim's own tissues), hepatitis (a liver disease), rheumatoid arthritis, Sjögren's syndrome (arthritis with inflammation of the eye, eyelid, and salivary glands), and systemic sclerosis (chronic hardening and shrinking of many body tissues).(b)
Classification. Class II (performance standards).