(379 days)
Not Found
No
The summary describes a standard fluorescence-immunoassay system for measuring rheumatoid factor antibodies, with no mention of AI or ML technologies.
No
This device is for in vitro diagnostic use, specifically for quantitative measurement of antibodies to aid in the diagnosis of rheumatoid arthritis, not for therapeutic intervention.
Yes
The 'Intended Use / Indications for Use' section explicitly states that the devices (EliA RF IgM and EliA RF IgA) are "intended... to aid in the diagnosis of rheumatoid arthritis" by measuring antibodies. This directly aligns with the definition of a diagnostic device.
No
The device description explicitly states it is a "fully integrated and automated system for immunodiagnostic testing" that "comprises 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 hardware components and reagents, not just software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use statements explicitly state that the devices are for "in vitro quantitative measurement" of antibodies in human serum and plasma. This is a key characteristic of IVDs, which are used to examine specimens taken from the human body.
- Device Description: The description details a "Fluorescence-Immunoassay test system" that uses "EliA single wells as the solid phase" and is performed on specific instruments. This describes a laboratory test system designed to analyze biological samples.
- Intended User / Care Setting: The intended user is "laboratory use," which is where IVD tests are typically performed.
- Predicate Devices: The predicate devices listed are also IVD tests (ELISA kits for measuring RF antibodies). This further supports the classification of the new devices as IVDs.
The device is designed to be used outside of the body (in vitro) to analyze human samples for diagnostic purposes (aiding in the diagnosis of rheumatoid arthritis). This aligns perfectly with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
-
EliA RF IgM is intended for the in vitro quantitative measurement of IgM class rheumatoid factor antibodies in human serum and plasma (Li-heparin, EDTA; citrate ) to aid in the diagnosis of rheumatoid arthritis in conjunction with other laboratory and clinical findings. EliA RF IgM uses the EliA IgM method on the instruments Phadia 100 and Phadia 250.
-
EliA RF IgA is intended for the in vitro quantitative measurement of IgA class rheumatoid factor antibodies in human serum and plasma (Li-heparin, EDTA, citrate) to aid in the diagnosis of rheumatoid arthritis in conjunction with other laboratory and clinical findings. EliA RF IgA uses the EliA IgA method on the instruments Phadia 100 and Phadia 250.
-
EliA RF Positive Control 100 is intended for laboratory use in monitoring the performance of in vitro measurement of rheumatoid factor (RF) with Phadia 100 using the EliA IgM or IgA method.
-
EliA RF Positive Control 250 is intended for laboratory use in monitoring the performance of in vitro measurement of rheumatoid factor (RF) with Phadia 250 using the EliA IgM or lgA method.
Product codes
DHR, JJY
Device Description
The new devices belong 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 IgM method is mouse anti-human IgM beta-galactosidase, which uses 4-Methylumbellifery1-BD-Galactoside as substrate.
The conjugate for the EliA IgA method is mouse anti-human IgA beta-galactosidase, which uses 4-Methylumbelliferyl-BD-Galactoside as substrate.
The total IgM and IgA calibration is based on a set of six WHO-standardized IgM and IgA Calibrators, respectively, 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-, method-specific and general reagents that are packaged as separate units.
Test Principle of the New Devices
The EliA Wells are coated with the following antigens:
EliA RF IgM: Aggregated rabbit IgG
EliA RF IgA: Aggregated rabbit IgG
If present in the patient's specimen, rheumatoid factor binds to the antigen. After washing away non-bound antibodies, enzyme-labeled antibodies against human IgM or IgA antibodies (EliA IgM or 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 more specific IgM or IgA is present in the specimen. To evaluate test results, the response for patient samples is compared directly to the response for calibrators.
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
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
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).
In summary, all available data support that the new devices are substantially equivalent to the predicate devices.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
SEP 3 0 2011
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: | |||
|---|---|---|---|
| Date of Summary Preparation: | July 30, 2010 | ||
| 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™ RF IgM Immunoassay | ||
| EliA™ RF IgA Immunoassay | |||
| EliA™ RF Positive Control 100 | |||
| EliA™ RF Positive Control 250 | |||
| Common Name: | Rheumatoid factor immunological test system | ||
| Classification | |||
| Product Name | Product Code | Class | CFR |
| EliA™ RF IgM | DHR | II | 866.5775 |
| EliA™ RF IgA | DHR | II | 866.5775 |
| EliA™ RF Positive Control | JJY | I | 862.1660 |
1
Substantial Equivalence to
| Quanta Lite Rf IgM Elisa | K971614 |
|---|---|
| Quanta Lite Rf IgA Elisa | K983084 |
Intended Use Statements of the New Devices
-
EliA RF IgM is intended for the in vitro quantitative measurement of IgM class rheumatoid factor antibodies in human serum and plasma (Li-heparin, EDTA; citrate ) to aid in the diagnosis of rheumatoid arthritis in conjunction with other laboratory and clinical findings. EliA RF IgM uses the EliA IgM method on the instruments Phadia 100 and Phadia 250.
-
EliA RF IgA is intended for the in vitro quantitative measurement of IgA class rheumatoid factor antibodies in human serum and plasma (Li-heparin, EDTA, citrate) to aid in the diagnosis of rheumatoid arthritis in conjunction with other laboratory and clinical findings. EliA RF IgA uses the EliA IgA method on the instruments Phadia 100 and Phadia 250.
-
EliA RF Positive Control 100 is intended for laboratory use in monitoring the performance of in vitro measurement of rheumatoid factor (RF) with Phadia 100 using the EliA IgM or IgA method.
-
EliA RF Positive Control 250 is intended for laboratory use in monitoring the performance of in vitro measurement of rheumatoid factor (RF) with Phadia 250 using the EliA IgM or lgA method.
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 Devices
The new devices belong 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 IgM method is mouse anti-human IgM beta-galactosidase, which uses 4-Methylumbellifery1-BD-Galactoside as substrate.
The conjugate for the EliA IgA method is mouse anti-human IgA beta-galactosidase, which uses 4-Methylumbelliferyl-BD-Galactoside as substrate.
The total IgM and IgA calibration is based on a set of six WHO-standardized IgM and IgA Calibrators, respectively, 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-, method-specific and general reagents that are packaged as separate units.
Test Principle of the New Devices
The EliA Wells are coated with the following antigens:
| Test | Antigen coated to the wells: |
|---|---|
| EliA RF IgM | Aggregated rabbit IgG |
| EliA RF IgA | Aggregated rabbit IgG |
If present in the patient's specimen, rheumatoid factor binds to the antigen. After washing away non-bound antibodies, enzyme-labeled antibodies against human IgM or IgA antibodies (EliA IgM or 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 more specific IgM or IgA is present in the specimen. 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 devices both represent non-competitive solid phase ELISAs. 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 devices are substantially equivalent to the predicate devices.
4
Image /page/4/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized eagle with three lines representing its body and wings. The eagle faces right and appears to be in flight. Encircling the eagle is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" in a circular arrangement.
Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993
Phadia US, Inc. c/o Mr. Martin Mann Regulatory Affairs Manager 4169 Commercial Avenue Portage, MI 49002
SEP 30 2011
Re: K102673 Trade/Device Name: EliATM RF IgM Immunoassay EliA™ RF IgA Immunoassay EliA™ RF Positive Control 100 EliA™ RF Positive Control 250 Regulation Number: 21 CFR §866.5775 Regulation Name: Rheumatoid factor immunological test system Regulatory Class: Class II (assay) Product Codes: DHR, JJY Dated: August 29, 2011 Received: August 30, 2011
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 10 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 class II (Special Controls), it may be subject to such additional controls. Existing 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 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
5
Page 2 – Mr. Martin Mann
CFR Part 807); labeling (21 CFR Parts 801 and 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); and 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 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.
Ca
Reena Philip
Maria M. Chan, 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
6
K102673 510(k) Number:
EliA™ RF IgM Device Name:
Indication For Use:
EliA RF IgM is intended for the in vitro semi-quantitative measurement of IgM class rheumatoid factor antibodies in human serum and plasma (Liheparin, EDTA, citrate) to aid in the diagnosis of rheumatoid arthritis in conjunction with other laboratory and clinical findings. EliA RF IgM uses the EliA IgM 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 (OVD)
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K 102673
7
510(k) Number: K102673
EliA™ RF IgA Device Name:
Indication For Use:
EliA RF IgA is intended for the in vitro semi-quantitative measurement of IgA class rheumatoid factor antibodies in human serum and plasma (Liheparin, EDTA, citrate) to aid in the diagnosis of rheumatoid arthritis in conjunction with other laboratory and clinical findings. EliA RF IgA uses the EliA IgA method on the instruments Phadia 100 and Phadia 250.
Prescription Use _____________________________________________________________________________________________________________________________________________________________ (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)
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K102673
8
510(k) Number (if known):
Device Name:
EliA™ RF Positive Control 100
Indication For Use:
EliA RF Positive Control 100 is intended for laboratory use in monitoring the performance of in vitro measurement of rheumatoid factor (RF) with Phadia 100 using the EliA IgM or IgA method.
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 (OVD)
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K102673
Page 1 of 1
9
长102673
510(k) Number (if known):
Device Name:
EliA™ RF Positive Control 250
Indication For Use:
EliA RF Positive Control 250 is intended for laboratory use in monitoring the performance of in vitro measurement of rheumatoid factor (RF) with Phadia 250 using the EliA IgM or IgA method.
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 (OVD)
Division Sign Off
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K102673
Page 1 of 1