(305 days)
Not Found
No
The description focuses on a standard immunoassay system and does not mention any AI or ML components or functionalities.
No.
Explanation: The device is an in vitro diagnostic (IVD) tool intended for the semi-quantitative measurement of antibodies to aid in the diagnosis of antiphospholipid syndrome (APS) and thrombotic disorders related to SLE. It does not directly provide therapy or treatment to a patient.
Yes
The device is described as aiding in the "diagnosis of antiphospholipid syndrome (APS) as well as thrombotic disorders." It measures IgA antibodies to help with diagnosis, indicating its role in providing diagnostic information.
No
The device description explicitly states it is a "Fluorescence-Immunoassay test system using EliA single wells as the solid phase" and is performed on specific instruments (Phadia 100 and Phadia 250). This indicates the device includes physical components (reagents, wells, and relies on hardware instruments) and is 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 the in vitro semi-quantitative measurement of IgA antibodies directed to ß2-Glycoprotein I in human serum and plasma... to aid in the diagnosis of antiphospholipid syndrome (APS) as well as thrombotic disorders related to systemic lupus erythematosus (SLE)." The phrase "in vitro" is a key indicator of an IVD, meaning it's used to examine specimens from the human body outside of the body.
- Device Description: The description details a "Fluorescence-Immunoassay test system using EliA single wells as the solid phase," which is a common method used in IVD testing to detect specific substances in biological samples.
- Sample Type: The device is designed to test "human serum and plasma," which are biological specimens.
- Purpose: The purpose is to "aid in the diagnosis," which is a core function of many IVD devices.
Therefore, based on the provided information, the EliA ß2-Glycoprotein I IgA device clearly fits the definition of an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
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.
Product codes
MSV
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.
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
Prescription 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
Not Found
Summary of Performance Studies
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).
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
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
Intended Use Statement of the New Device
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.
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 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.
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