(379 days)
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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.
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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.
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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.
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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.
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.
The provided document describes the EliA™ RF IgM Immunoassay and EliA™ RF IgA Immunoassay, along with their respective positive controls, for aiding in the diagnosis of rheumatoid arthritis. The study provided focuses on establishing laboratory equivalence to a predicate device, rather than defining specific acceptance criteria for diagnostic performance metrics like sensitivity or specificity against a clinical ground truth.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state numerical acceptance criteria in terms of diagnostic performance metrics (e.g., sensitivity, specificity, accuracy) that the device must meet against a predefined standard of truth. Instead, the study's goal was to demonstrate laboratory equivalence to existing predicate devices.
The "reported device performance" is summarized conceptually as:
| Criterion Type | Acceptance Criterion (Implicit) | Reported Device Performance |
|---|---|---|
| Laboratory Equivalence to Predicate Device | The new devices (EliA™ RF IgM and EliA™ RF IgA) should demonstrate comparable performance to their respective predicate devices (Quanta Lite Rf IgM Elisa and Quanta Lite Rf IgA Elisa) across various sample types (comparison study, clinically defined sera, healthy subjects). This implies similar quantitative results and clinical interpretations. | "In summary, all available data support that the new devices are substantially equivalent to the predicate devices." (No specific numerical metrics are provided in this summary section.) |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: 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, the exact numerical sample sizes for these test sets are not provided.
- Data Provenance: The document does not specify the country of origin for the data. The study appears to be retrospective, as it involves comparing results from existing serum and plasma samples with the new devices against predicate devices.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document does not describe the establishment of a "ground truth" for the test set in the traditional sense of expert consensus on patient diagnosis. Instead, the study aims to establish equivalence to predicate devices. The "clinically defined sera" used would have implicit ground truth based on their clinical diagnosis of rheumatoid arthritis, but the process of establishing this clinical diagnosis (e.g., how many experts, their qualifications) is not detailed. It's likely these were pre-diagnosed samples.
4. Adjudication Method for the Test Set
Since the study focuses on laboratory equivalence to predicate devices and not on establishing a new diagnostic ground truth by expert review, an adjudication method (like 2+1 or 3+1) for diagnosing patients within the test set is not applicable and not mentioned.
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
This section is not applicable to this device. The EliA™ RF immunoassays are in vitro diagnostic devices that measure specific antibodies in patient samples. They are not AI-powered devices that assist human readers (e.g., radiologists) in interpreting medical images or other complex data. Therefore, an MRMC study and the concept of "human readers improving with AI assistance" are outside the scope of this submission.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
The EliA™ RF immunoassays are standalone devices in the sense that they provide quantitative measurements of RF IgM and IgA levels directly. The "algorithm" here is the biochemical assay and the instrument's software for calculating results from fluorescence measurements. Their performance is evaluated independently of human interpretation of the raw assay signal (though a clinician then interprets the final quantitative result). The study described focuses on this standalone performance in comparison to predicate devices.
7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)
The primary "ground truth" for the comparison study is the results obtained from the legally marketed predicate devices. For the "clinically defined sera," the ground truth would be the clinical diagnosis of Rheumatoid Arthritis established by treating physicians using a combination of clinical findings and other laboratory tests. For "samples from apparently healthy subjects," the ground truth is the absence of Rheumatoid Arthritis. The method by which these clinical diagnoses were originally established (e.g., based on ACR/EULAR criteria, pathology, long-term outcomes) is not specified in this document.
8. The Sample Size for the Training Set
The document does not specify a separate "training set" sample size. For immunoassay development, "training" typically refers to the development and optimization of the assay itself, selection of reagents, and establishment of calibration curves. The document mentions that the total IgM and IgA calibration is based on a set of six WHO-standardized IgM and IgA Calibrators, but this is for calibration, not a "training set" in the context of machine learning.
9. How the Ground Truth for the Training Set Was Established
As no specific "training set" in the machine learning sense is described, the question of how its ground truth was established is not applicable. The "ground truth" for the instrument's calibration is based on WHO-standardized IgM and IgA Calibrators, which are reference materials with known concentrations.
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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 ABRapsgatan 7SE-751 37 Uppsala, Sweden | ||
| 510 (k) Contact Person: | Martin MannRegulatory Affairs ManagerPhadia US Inc.4169 Commercial AvenuePortage, Mi 49002, USA+1 (-269-492) -1957 (Phone)+1 (-269-492) -7541 (Fax)martin.mann@phadia.com | ||
| Device Name: | EliA™ RF IgM ImmunoassayEliA™ RF IgA ImmunoassayEliA™ RF Positive Control 100EliA™ 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 |
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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.
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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.
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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.
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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
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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
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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
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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
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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
§ 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).