(99 days)
Not Found
No
The summary describes a standard automated immunoassay system for measuring antibodies, with no mention of AI or ML in the device description, intended use, or performance studies.
No.
The device is used for in vitro diagnostic measurement of antibodies to aid in the diagnosis of rheumatoid arthritis, not for treating or managing a disease.
Yes
The very first sentence under "Intended Use / Indications for Use" states that the device is "intended for the in vitro semi-quantitative measurement of IgG antibodies directed to CCP in human serum and plasma." This measurement is then explicitly stated to be "used in conjunction with clinical findings and other laboratory tests as an aid in the clinical diagnosis of rheumatoid arthritis (RA)." This clearly indicates its role in diagnosis.
No
The device description explicitly states it is a "Fluorescence-Immunoassay test system" that uses "EliA single wells as the solid phase" and includes "test-, method specific and general reagents". These are physical components, not solely software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states that the device is intended for "in vitro semi-quantitative measurement of IgG antibodies directed to CCP in human serum and plasma." The term "in vitro" is a key indicator of an IVD.
- Purpose: The purpose is to aid in the clinical diagnosis of rheumatoid arthritis (RA) by measuring specific antibodies in a biological sample (serum and plasma). This is a diagnostic purpose performed outside of the body.
- Device Description: The description details a "Fluorescence-Immunoassay test system" that uses reagents and instruments to analyze biological samples. This aligns with the nature of IVD devices.
- Intended User / Care Setting: The intended user is "laboratory use," which is a typical setting for performing in vitro diagnostic tests.
Therefore, based on the provided information, the EliA CCP device clearly fits the definition of an In Vitro Diagnostic device.
N/A
Intended Use / 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.
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.
Product codes (comma separated list FDA assigned to the subject device)
NHX
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
EliA CCP is intended for prescription use only. EliA CCP Control is intended for laboratory use.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
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 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.
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
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.
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
2
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.
3
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
5
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
6
Indications for Use
510(k) Number:
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
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