EliA CCP is intended for the in vitro semi-quantitative measurement of IgG antibodies directed to CCP in human serum and plasma. The presence of anti-CCP antibodies can be used in conjunction with clinical findings and other laboratory tests as an aid in the clinical diagnosis of rheumatoid arthritis (RA). EliA CCP uses the EliA IgG method on the instruments ImmunoCAP 100 and ImmunoCAP 250.

EliA CCP Control is intended for laboratory use in monitoring the performance of in vitro measurement of anti-cyclic citrullinated peptide (CCP) antibodies with ImmunoCAP 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 may be used for up to one month on additional assays and can be stored by the instrument. Each additional assay includes calibrator (curve) controls that have to be measured in defined ranges to check whether 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 is a 510(k) summary for the EliA™ CCP and EliA™ CCP Control devices. It primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed study proving the device meets specific acceptance criteria in the sense of clinical performance metrics like sensitivity, specificity, etc., against a defined ground truth.

However, based on the provided text, we can extract information relating to the "study" conducted for equivalence.

Acceptance Criteria and Reported Device Performance

The document does not explicitly state numerical "acceptance criteria" for performance metrics like sensitivity or specificity. Instead, the "acceptance criteria" are implied by the demonstration of substantial equivalence to the predicate device, Axis-Shield Diastat Anti-CCP (510(k) number: K023285). The reported "performance" relates to the comparability study.

Acceptance Criteria (Implied)	Reported Device Performance
Substantial equivalence to the predicate device (Axis-Shield Diastat Anti-CCP) across various sample types.	Data supports that the new device is substantially equivalent to the predicate device through:Comparison study results between new and predicate deviceResults for clinically defined seraResults for samples from apparently healthy subjects (normal population)

Study Details

Sample sizes used for the test set and the data provenance:
- Test Set Sample Size: Not explicitly stated. The document mentions "a data set" for comparability but does not provide specific numbers for the comparison study, clinically defined sera, or apparently healthy subjects.
- Data Provenance: Not explicitly stated (e.g., country of origin). The study involved "clinically defined sera" and "samples from apparently healthy subjects," which implies human samples, but details are missing. It is likely retrospective, as it involves comparing the new device's results with an existing predicate, and "clinically defined sera" suggest samples with known diagnoses.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable/Not provided. This type of device (an in-vitro diagnostic for antibodies) primarily relies on the predicate device's established performance as the benchmark for "ground truth" in an equivalence study, rather than expert consensus on images or clinical assessments for the test set itself. The "clinically defined sera" would have their ground truth established by established clinical diagnostic criteria for rheumatoid arthritis (RA).
Adjudication method for the test set: Not applicable/Not provided. Adjudication methods like 2+1 or 3+1 are typically for subjective assessments (e.g., image interpretation). For an immunoassay, the readouts are quantitative or semi-quantitative and are directly compared.
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 device, not an AI-powered diagnostic that assists human readers.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The device itself, EliA™ CCP, is a standalone in-vitro diagnostic immunoassay system. It performs its measurement and provides results without human interpretive assistance in the direct measurement process, though human interpretation of the results in conjunction with clinical findings is required for diagnosis. The study described is a standalone performance comparison.
The type of ground truth used:
- For the comparability study against the predicate device, the "ground truth" for the new device's performance is essentially the results obtained from the predicate device.
- For the clinically defined sera, the ground truth would be the established clinical diagnosis of rheumatoid arthritis (RA) or healthy status, likely based on a combination of clinical findings, established diagnostic criteria (e.g., ACR/EULAR criteria for RA), and other laboratory tests.
- For samples from apparently healthy subjects, the ground truth is their healthy status.
The sample size for the training set: Not applicable. This is not a machine learning or AI device that requires a training set in the conventional sense. It's a biochemical assay.
How the ground truth for the training set was established: Not applicable, as there is no training set mentioned for this type of device.

Summary

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510(K) SUMMARY OF SAFETY AND EFFECTIVENESS 9.

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:	K061165	AUG 0 3 2006
Date of Summary Preparation:	April 13, 2006
Manufacturer:	Phadia AB Rapsgatan 7 SE-751 37 Uppsala, Sweden
510 (k) Contact Person:	Martin Mann Regulatory Affairs Manager Sweden Diagnostics (US) Inc. A Phadia company 4169 Commercial Avenue Portage, Mi 49002 , USA +1 (-269-492) -1957 (Phone) +1 (-269-492) -7541 (Fax) martin.mann@diagnostics.com
Device Name:	EliA™ CCP EliA™ CCP Control
Common Name:	Anti-CCP Antibodies immunological test system

Classification

Product Name	Product Code	Class	CFR
--------------	--------------	-------	-----

EliA™ CCP EliA™ CCP Control NHX II 866.5775 II NHX 866.5775

Substantial Equivalence to Axis-Shield Diastat Anti-CCP

510(k) number: K023285

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Intended Use Statement of the New Device

EliA CCP Control is intended for laboratory use in monitoring the performance of in vitro measurement of anti-cyclic citrullinated peptide (CCP) antibodies with ImmunoCAP using the EliA IgG method.

Special condition for use statement The device is for prescription use only.

Special instrument requirements

ImmunoCAP100/ImmunoCAP250 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 CCP Wells are coated with citrullinated synthetic peptides. If present in the patient's specimen, antibodies to CCP 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

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K061165

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 represent non-competitive solid phase EIAs. Both IVDs are used as an aid in the diagnosis of rheumatoid arthritis.

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 Department of Health & Human Services - USA. The logo features a stylized eagle with its wings spread, symbolizing protection and care. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle emblem.

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

AUG 0 3 2006

Sweden Diagnostics (US) Inc. c/o Mr. Martin Mann Regulatory Affairs Manager 4169 Commercial Avenue Portage, MI 49002

Re: K061165

Trade/Device Name: EliA™ CCP and EliA™ CCP Control Regulation Number: 21 CFR 866.5775 Regulation Name: Rheumatoid Factor Immunological Test System Regulatory Class: Class II Product Code: NHX Dated: April 25, 2006 Received: April 26, 2006

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 four din 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); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 -

This letter will allow you to begin marketing your device as described in your Section 510(k) rms letter notification. The FDA finding of substantial equivalence of your device to a legally premated notificate 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 Part 801), please contact the Office of Compliance at (240) 276-0484. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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,

mana In chan

Robert L. Becker, Jr., M.D., 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:

KO61165

Device Name:

EliATM CCP

Indications For Use:

EliA CCP is intended for the in vitro semi-quantitative measurement of IgG antibodies directed to cyclic citrullinated peptides (CCP) in human serum and plasma. The presence of anti-CCP antibodies can be used in conjunction with clinical findings and other laboratory tests as an aid in the clinical diagnosis of rheumatoid arthritis (RA). EliA CCP uses the EliA IgG method on the instruments ImmunoCAP 100 and ImmunoCAP 250.

Prescription Use V

AND/OR

Over-The-Counter Use

(Part 21 CFR 801 Subpart D)

(21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

CONFIDENTIAL AND PROPRIETARY

Page 1

Mona M Chan

Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K061165

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Indications for Use

510(k) Number:

K061165

Device Name:

EliA™ CCP Control

Indications For Use:

EliA CCP Control is intended for laboratory use in monitoring the performance of in vitro measurement of anti-cyclic citrullinated peptide (CCP) antibodies with ImmunoCAP using the EliA IgG method.

ia m chan

Division Sign-Off

Office of in Vitre Diagnostic Device Evaluation and Safety

K061165

Prescription Use _ V (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 Device Evaluation (ODE)

CONFIDENTIAL AND PROPRIETARY

Regulation Number and Section

§ 866.5775 Rheumatoid factor immunological test system.

(a)
Identification. A rheumatoid factor immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the rheumatoid factor (antibodies to immunoglobulins) in serum, other body fluids, and tissues. Measurement of rheumatoid factor may aid in the diagnosis of rheumatoid arthritis.(b)
Classification. Class II (performance standards).