(165 days)
EliA Symphony Immunoassay is intended for the in vitro qualitative measurement of antinuclear IgG antibodies in human serum and plasma (heparin, EDTA and citrate). EliA Symphony Immunoassay is based on human recombinant U1RNP (RNP 70, A, C). SS-A/Ro (60 kDa. 52 kDa), SS-B/La, Centromere B, Sc1-70, Jo-1 proteins and native purified Sm proteins as antigen and is useful as an aid in the clinical diagnosis of patients with systemic lupus erythematosus (SLE), mixed connective tissue disease (MCTD), Sjögren's syndrome, scleroderma and polymyositis/dermatomyositis, in conjunction with other laboratory and clinical findings. EliA Symphony Immunoassay uses the EliA IgG method on the instrument ImmunoCAP 100 and ImmunoCAP 250.
EliA ANA Control is intended for laboratory use in monitoring the performance of in vitro measurement of antinuclear antibodics (ANA) with ImmunoCAP 100 or ImmunoCAP 250 using the EliA IgG method.
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-Methylumbellifery|-8D-Galactoside as substrate. The total IgG calibration is based on a set of six WHOstandardized IgG 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-, method specific and general reagents that are packaged as separate units.
The provided text describes the EliA™ Symphony Immunoassay and EliA™ ANA Control, but it does not contain a detailed study proving the device meets specific acceptance criteria with reported performance metrics, sample sizes, ground truth establishment, or expert qualifications.
The document is a 510(k) summary for premarket notification, indicating substantial equivalence to predicate devices, rather than a detailed clinical study report. It mentions "laboratory equivalence" being supported by "a data set including results obtained within a comparison study between new and predicate devices," "results obtained for clinically defined sera," and "results obtained for samples from apparently healthy subjects (normal population)," but it lacks specific details about these studies.
Therefore, many of the requested details cannot be extracted from this document.
Here's a breakdown of what can be inferred or is explicitly stated, alongside what is missing:
1. Table of Acceptance Criteria and Reported Device Performance
Cannot be provided definitively from the given text.
The document states: "In summary, all available data support the conclusion that the new device is substantially equivalent to the predicate devices." This implies that the acceptance criterion was likely demonstrating substantial equivalence through comparable performance to the predicate devices (QUANTA Lite™ ENA 6 and NOVA Lite™ HEp-2). However, specific performance metrics (e.g., sensitivity, specificity, accuracy with numerical thresholds) for the new device or the study results are not reported in this summary.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not explicitly stated.
- Data Provenance: The document mentions "results obtained for clinically defined sera" and "results obtained for samples from apparently healthy subjects (normal population)." This suggests that real patient samples were used, but the country of origin is not specified, and it implies a retrospective or mixed collection of known samples.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Not explicitly stated. The document is for an immunoassay, where ground truth is typically established by clinical diagnosis and/or other laboratory results, not necessarily by interpretation of images by a panel of human experts in the same way as an imaging device.
4. Adjudication Method for the Test Set
Not explicitly stated. Given the nature of an immunoassay, traditional adjudication methods like "2+1" or "3+1" are not applicable. Ground truth would have been established through clinical diagnosis (e.g., of SLE, MCTD, Sjögren's syndrome, scleroderma, polymyositis/dermatomyositis) or by comparison to the predicate device results.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for devices that involve human interpretation of results (e.g., imaging devices) to assess how the device assists human readers. The EliA Symphony Immunoassay is an automated immunoassay.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Yes, the device operates in a standalone manner. The EliA Symphony Immunoassay is described as a "fully integrated and automated system for immunodiagnostic testing" that uses instruments ImmunoCAP 100/250 and software for evaluation. Its performance is measured intrinsically, not in conjunction with human interpretation in the loop in the sense of an assist device for cognitive tasks.
7. The Type of Ground Truth Used
The ground truth for evaluating the device would be based on:
- Clinical Diagnosis: Diagnosis of systemic lupus erythematosus (SLE), mixed connective tissue disease (MCTD), Sjögren's syndrome, scleroderma, and polymyositis/dermatomyositis. The device is intended as an "aid in the clinical diagnosis" using "other laboratory and clinical findings."
- Predicate Device Results: Comparison studies were performed against the QUANTA Lite™ ENA 6 and NOVA Lite™ HEp-2 assays. This implies the predicate device results served as a reference point for substantial equivalence.
8. The Sample Size for the Training Set
Not explicitly stated. The document is a 510(k) summary and focuses on demonstrating equivalence rather than detailing the development and training of a machine learning model, which is what "training set" typically refers to. For an immunoassay, the concept of a "training set" for an algorithm in the AI/ML sense is not directly applicable. Method development and optimization would likely have involved numerous samples, but these are not quantified here.
9. How the Ground Truth for the Training Set was Established
Not applicable in the context of an AI/ML training set. The "training" of an immunoassay involves method development and optimization to achieve desired performance characteristics. This would rely on well-characterized samples (e.g., clinically diagnosed patient samples, controls) to establish the assay's sensitivity, specificity, and accurate measurement of analytes. The process is one of analytical validation and optimization rather than machine learning model training.
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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: | K072149 | JAN 15 2008 | ||
|---|---|---|---|---|
| Date of Summary Preparation: | January 7, 2008 | |||
| Manufacturer: | Phadia ABRapsgatan 7SE-751 37 Uppsala, Sweden | |||
| 510 (k) Contact Person: | Martin MannRegulatory Affairs ManagerPhadia US Inc.4169 Commercial AvenuePortage, Mi 49002, USA269-492-1957 (Phone)269-492-7541 (Fax)martin.mann@phadia.com | |||
| Device Name: | EliA™ Symphony ImmunoassayEliA™ ANA Control | |||
| Common Name: | Antinuclear antibody immunological test system andControl | |||
| Classification | ||||
| Product Name | Product Code | Class | CFR | |
| EliA™ Symphony ImmunoassayEliA™ ANA Control | LLLLLL | IIII | 866.5100866.5100 | |
| Substantial Equivalence toQUANTA Lite™ ENA 6(predicate device for RNP Antibodies,SS-A/Ro Antibodies, SS-B/La Antibodies,Scl-70 Antibodies, Jo-1 Antibodiesand Sm Antibodies) | 510(k) number: K961913 |
CONFIDENTIAL AND PROPRIETARY
(predicate device for CENP Antibodies)
NOVA Lite™ HEp-2
510(k) number: K880736
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Intended Use Statement of the New Device
EliA Symphony Immunoassav is intended for the in vitro qualitative measurement of antinuclear IgG antibodies in human serum and plasma (heparin, EDTA and citrate). EliA Symphony Immunoassay is based on human recombinant U1RNP (RNP 70, A, C). SS-A/Ro (60 kDa. 52 kDa), SS-B/La, Centromere B, Sc1-70, Jo-1 proteins and native purified Sm proteins as antigen and is useful as an aid in the clinical diagnosis of patients with systemic lupus erythematosus (SLE), mixed connective tissue disease (MCTD), Sjögren's syndrome, scleroderma and polymyositis/dermatomyositis, in conjunction with other laboratory and clinical findings. EliA Symphony Immunoassay uses the EliA IgG method on the instrument ImmunoCAP 100 and ImmunoCAP 250.
EliA ANA Control is intended for laboratory use in monitoring the performance of in vitro measurement of antinuclear antibodics (ANA) with ImmunoCAP 100 or ImmunoCAP 250 using the EliA IgG method.
Special condition for use statement
The device is for prescription use only.
Special instrument requirements
ImmunoCAP 100 / ImmunoCAP 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 ImmunoCAP 100 and ImmunoCAP 250. The conjugate for the EliA IgG method is mouse anti-human IgG beta-galactosidase, which uses 4-Methylumbellifery|-8D-Galactoside as substrate. The total IgG calibration is based on a set of six WHOstandardized IgG 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-, method specific and general reagents that are packaged as separate units.
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Test Principle of the New Device
The EliA Symphony Wells are coated with human recombinant U1RNP (RNP 70, A, C), SS-A/Ro (60 kDa, 52 kDa), SS-B/La, Centromere B, Scl-70 and Jo-1 proteins, native purified Sm proteins. If present in the patient's specimen, antibodies to the antigens 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 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. The predicate device for the demonstration of the Centromere B antigen was an IIF, NOVA Lite™ HEp-2 assay. These IVDs are used as an aid in the diagnosis of Systemic Lupus Erythematosus (SLE) and related connective tissue diseases, in conjunction with other laboratory and clinical findings.
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 devices
- · results obtained for clinically defined sera
- · results obtained for samples from apparently healthy subjects (normal population).
In summary, all available data support the conclusion that the new device is substantially equivalent to the predicate devices.
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Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services. The logo is a circle with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an abstract image of an eagle.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Phadia US Inc. c/o Mr. Martin R. Mann Regulatory Affairs Manager 4169 Commercial Ave Portage, MI 49002
JAN I 5 2008
Re: K072149
Trade/Device Name: EliA™ Symphony Immunoassay and EliA™ ANA Control Regulation Number: 21 CFR 866.5100 Regulation Name: Antinuclear antibody immunological test system Regulatory Class: Class II Product Code: LLL Dated: January 10, 2008 Received: January 14, 2008
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 found in 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 (OS) 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
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Page 2 –
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 information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (240) 276-0450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 vours.
Robert H. Baker
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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1. Indications for Use Statements
Indications for Use
510(k) Number:
Device Name:
EliATM Symphony Immunoassay
Indications For Use:
EliA Symphony Immunoassay is intended for the in vitro, qualitative measurement of antinuclear IgG antibodies in human serum and plasma (heparin, EDTA and citrate). EliA Symphony Immunoassay is based on human recombinant UIRNP (RNP 70, A, C), SS-A/Ro (60 kDa, 52 kDa), SS-B/La, Centromere B, Sc!-70, Jo-1 proteins and native purified Sm proteins as antigen and is useful as an aid in the clinical diagnosis of patients with systemic lupus erythematosus (SLE), mixed connective tissue disease (MCTD), Sjögren's syndrome, scleroderma and polymyositis/dermatomyositis, in conjunction with other laboratory and clinical findings. EliA Symphony Immunoassay uses the EliA IgG method on the instrument ImmunoCAP 100 and ImmunoCAP 250.
Prescription Use AND/OR (Part 21 CFR 801 Subpart D)
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)
Mana M. Che
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
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Indications for Use
510(k) Number:
Device Name:
EliA™ ANA Control
Indications For Use:
EliA ANA Control is intended for laboratory use in monitoring the performance of in vitro measurement of antinuclear antibodies (ANA) with ImmunoCAP 100 or ImmunoCAP 250 using the EliA IgG method.
Prescription Use AND/OR (Part 21 CFR 801 Subpart D)
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)
m Chan
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
CONFIDENTIAL AND PROPRIETARY C12177
Page 2
§ 866.5100 Antinuclear antibody immunological test system.
(a)
Identification. An antinuclear antibody immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the autoimmune antibodies in serum, other body fluids, and tissues that react with cellular nuclear constituents (molecules present in the nucleus of a cell, such as ribonucleic acid, deoxyribonucleic acid, or nuclear proteins). The measurements aid in the diagnosis of systemic lupus erythematosus (a multisystem autoimmune disease in which antibodies attack the victim's own tissues), hepatitis (a liver disease), rheumatoid arthritis, Sjögren's syndrome (arthritis with inflammation of the eye, eyelid, and salivary glands), and systemic sclerosis (chronic hardening and shrinking of many body tissues).(b)
Classification. Class II (performance standards).