(102 days)
Not Found
No
The description details a standard automated immunoassay system and does not mention any AI or ML components for data analysis, interpretation, or decision-making.
No
The device is an in vitro diagnostic (IVD) device used for quantitative measurement of antibodies to aid in diagnosis, not for treating any condition.
Yes
The "Intended Use / Indications for Use" section explicitly states that EliA dsDNA is "intended for the in vitro quantitative measurement of IgG antibodies directed to dsDNA... as an aid in the clinical diagnosis of systemic lupus erythematosus (SLE)". This directly 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 EliA dsDNA is intended for "in vitro quantitative measurement of IgG antibodies directed to dsDNA in human serum and plasma... as an aid in the clinical diagnosis of systemic lupus erythematosus (SLE)". The EliA ANA Control is also intended for "laboratory use in monitoring the performance of in vitro measurement of antinuclear antibodies (ANA)". The term "in vitro" is a key indicator of an IVD.
- Device Description: The description details a "Fluorescence-Immunoassay test system using EliA single wells as the solid phase" and mentions the use of reagents and calibrators to perform tests on human samples (serum and plasma). This aligns with the nature of IVD devices, which are used to examine specimens derived from the human body to provide information for diagnostic purposes.
- Intended User / Care Setting: The intended user is specified as "laboratory use", which is a typical setting for performing in vitro diagnostic tests.
Therefore, based on the provided information, the device clearly fits the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
EliA dsDNA is intended for the in vitro quantitative measurement of IgG antibodies directed to dsDNA in human serum and plasma (heparin, EDTA, citrate) as an aid in the clinical diagnosis of systemic lupus erythematosus (SLE) in conjunction with other laboratory and clinical findings. EliA dsDNA Immunoassav 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 antibodies (ANA) with ImmunoCAP 100 or ImmunoCAP 250 using the EliA IgG method.
Product codes (comma separated list FDA assigned to the subject device)
LRM, JJY
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-Methylumbelliferyl-BD-Galactoside as substrate. The total IgG calibration is based on a set of six WHO-standardized 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 EliA dsDNA Wells are coated with double-stranded plasmid DNA. If present in the patient's specimen, antibodies to dsDNA 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.
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.
The device is for prescription use only.
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 (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 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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).
Not Found
§ 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
DEC 07 2007
Image /page/0/Picture/2 description: The image contains a handwritten string of alphanumeric characters. The string appears to be 'K072393'. The characters are written in a simple, slightly irregular style, typical of handwriting.
9. 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: K072393
Date of Summary Preparation: December 3, 2007
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 TM dsDNA Immunoassay
EliATM ANA Control |
|--------------|-------------------------------------------------|
| Common Name: | Anti-dsDNA antibodies immunological |
Anti-dsDNA antibodies immunological test system and Control
Classification
Manufacturer:
| Product Name | Product Code | Class | CFR |
|---|---|---|---|
| EliA™ dsDNA Immunoassay | LRM | II | 866.5100 |
| EliA™ ANA Control | JJY | I | 862.1660 |
Substantial Equivalence to DPC anti-DNA
510(k) number: K874873
1
Intended Use Statement of the New Device
EliA dsDNA is intended for the in vitro quantitative measurement of IgG antibodies directed to dsDNA in human serum and plasma (heparin, EDTA, citrate) as an aid in the clinical diagnosis of systemic lupus erythematosus (SLE) in conjunction with other laboratory and clinical findings. EliA dsDNA Immunoassav 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 antibodies (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-Methylumbelliferyl-BD-Galactoside as substrate. The total IgG calibration is based on a set of six WHO-standardized IgG Calibrators derived from human serum. They are used to establish an initial calibration curve. which mav 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 Device
The EliA dsDNA Wells are coated with double-stranded plasmid DNA. If present in the patient's specimen, antibodies to dsDNA 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
2
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 are used as an aid in the diagnosis of Systemic Lupus Erythematosus (SLE) 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 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.
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three lines representing its body and wings. The eagle is facing right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle.
Public Health Service
DEC 0 7 2007
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
Re: K072393 Trade/Device Name: EliATM dsDNA Regulation Number: 21 CFR 866.5100 Regulation Name: Antinuclear autoantibody, antigen and control Regulatory Class: Class II Product Code: LSW, JJY Dated: November 26, 2007 Received: November 27, 2007
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 (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
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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 yours,
Thos. T. Beall
Robert L. Becker, Jr., M.L , 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
5
EliA™ dsDNA - New Device 510(k) Submission Section 1: Indications for Use Statement
Indications for Use
510(k) Number:
Device Name:
EliA™ dsDNA
Indications For Use:
EliA dsDNA is intended for the in vitro quantitative measurement of IgG antibodies directed to dsDNA in human serum and plasma (heparin, EDTA, citrate) as an aid in the clinical diagnosis of systemic lupus erythematosus (SLE) in conjunction with other laboratory and clinical findings. EliA dsDNA uses the EliA IgG method on the instrument ImmunoCAP 100 and ImmunoCAP 250.
Prescription Use V 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)
Mana M Chan
Division Sign-Off
Concurrence of CDRH, Office of Device Evaluation (ODE)
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K0 72543
CONFIDENTIAL AND PROPRIETARY
Page I
6
EliA™ dsDNA – New Device 510(k) Submission Section 1: Indications for Use Statement
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.
_ AND/OR Prescription Use _ V (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)
m chon
Concurrence of CDRH, Office of Device Evaluation (ODE Division Sign-C
Office of In Vitro Diagnostic Device Evaluation and So
CONFIDENTIAL AND PROPRIETARY
510(K) [K07259] Page 2