(165 days)
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No
The document describes a standard automated immunoassay system and does not mention any AI or ML components or functionalities.
No
The device is an in vitro diagnostic immunoassay intended for qualitative measurement of antibodies to aid in diagnosis, not for treatment.
Yes
Explanation: The "Intended Use / Indications for Use" section states that the device 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." This clearly indicates its role in diagnosis.
No
The device description explicitly states it is a "fully integrated and automated system for immunodiagnostic testing" and "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." This indicates the device includes hardware components (the test system, wells, and 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 "in vitro qualitative measurement of antinuclear IgG antibodies in human serum and plasma". "In vitro" means "in glass" or "outside the body," which is a key characteristic of IVDs.
- Sample Type: The device analyzes "human serum and plasma," which are biological samples taken from the human body.
- Purpose: The purpose is to aid in the "clinical diagnosis of patients with systemic lupus erythematosus (SLE), mixed connective tissue disease (MCTD), Sjögren's syndrome, scleroderma and polymyositis/dermatomyositis". This diagnostic purpose is central to the definition of an IVD.
- Laboratory Use: The "Intended User / Care Setting" is "Laboratory use," indicating that the testing is performed in a laboratory setting, which is typical for IVDs.
- Control Device: The description also includes an "EliA ANA Control" which is "intended for laboratory use in monitoring the performance of in vitro measurement of antinuclear antibodics (ANA)". This control is also an IVD component used to ensure the accuracy of the diagnostic test.
All of these factors clearly indicate that the EliA Symphony Immunoassay and its associated control are intended for in vitro diagnostic use.
N/A
Intended Use / 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 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.
Product codes (comma separated list FDA assigned to the subject device)
LLL
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-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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
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Anatomical Site
Not Found
Indicated Patient Age Range
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Intended User / Care Setting
laboratory use for EliA ANA Control, prescription use only.
Description of the training set, sample size, data source, and annotation protocol
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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 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.
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).
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§ 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).
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: | K072149 | JAN 15 2008 | ||
|---|---|---|---|---|
| Date of Summary Preparation: | January 7, 2008 | |||
| 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 | ||||
| 269-492-1957 (Phone) | ||||
| 269-492-7541 (Fax) | ||||
| martin.mann@phadia.com | ||||
| Device Name: | EliA™ Symphony Immunoassay | |||
| EliA™ ANA Control | ||||
| Common Name: | Antinuclear antibody immunological test system and | |||
| Control | ||||
| Classification | ||||
| Product Name | Product Code | Class | CFR | |
| EliA™ Symphony Immunoassay | ||||
| EliA™ ANA Control | LLL | |||
| LLL | II | |||
| II | 866.5100 | |||
| 866.5100 | ||||
| Substantial Equivalence to | ||||
| QUANTA Lite™ ENA 6 | ||||
| (predicate device for RNP Antibodies, | ||||
| SS-A/Ro Antibodies, SS-B/La Antibodies, | ||||
| Scl-70 Antibodies, Jo-1 Antibodies | ||||
| and 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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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
6
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
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