(135 days)
No
The description details an ELISA kit for detecting antibodies, which is a standard laboratory assay technique and does not mention any AI or ML components.
No
The device is designed for aiding in the diagnosis of systemic rheumatic diseases by detecting antibodies, not for treating any condition.
Yes
The device is designed "to aid in the diagnosis of systemic rheumatic diseases," which clearly indicates its purpose as a diagnostic tool.
No
The device is an enzyme-linked immunosorbent assay (ELISA) kit, which is a laboratory test involving physical reagents and procedures, 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 kit is designed for the "qualitative determination of eight antinuclear antibodies in human serum or plasma... to aid in the diagnosis of systemic rheumatic diseases." This clearly indicates that the device is used to test samples taken from the human body (in vitro) to provide information for diagnostic purposes.
- Device Description: The "Device Description" further reinforces this by describing it as an "enzyme-linked immunosorbent assay (ELISA) for the qualitative determination of antinuclear antibodies in serum and plasma." This confirms it's a laboratory test performed on biological samples.
- Purpose: The overall purpose of the device is to detect specific antibodies in a patient's blood to help diagnose certain diseases. This is the core function of an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Varelisa ReCombi ANA Screen ElA kit is designed for the qualitative determination of eight antinuclear antibodies in human serum or plasma (citrate/EDTA) to aid in the diagnosis of systemic rheumatic diseases such as SLE (systemic lupus erythematosus), scleroderma (progressive systemic sclerosis), MCTD (mixed connective tissue disease), SS (Sjögren's syndrome) and polymyositis/ dermatomyositis. The Varelisa ReCombi ANA Screen detects antibodies against dsDNA, UIRNP (RNP70, A, C), Sm, SS-A/Ro (52 kDa,60 kDa), SS-B/La, Scl-70, CENP-B and Jo-1 in a single microwell.
Product codes
LJM
Device Description
The Varelisa ReCombi ANA Screen is an enzyme-linked immunosorbent assay (ELISA) for the qualitative determination of antinuclear antibodies in serum and plasma (citrate/EDTA). Designed as a screening assay, it detects eight antinuclear antibodies in a single microwell. The determination of antinuclear antibodies (ANA) is of central importance for the clinical diagnosis of rheumatic diseases. The presence of ANA suggests the possibility of rheumatic autoimmune diseases, These diseases include Systemic Lupus Erythemtosus (SLE), Polymyositis/ Dematomyositis, Scleroderma, Sjögren's Syndrome and Mixed Conective Tissue Diseases.
Varelisa ReCombi ANA Screen is an indirect noncompetitive enzyme immunoassay for the qualitative determination of 8 antinuclear antibodies in serum or plasma (citrate/EDTA). The wells of a microplate are coated with human recombinant nuclear antigens, synthetic peptides and dsDNA. Antibodies specific for the nuclear antigens present in a patient sample bind to these nuclear antigens.
In a second step the enzyme labeled second antibody (conjugate) binds to the antigen-antibody complex which leads to the formation of an enzyme labeled conjugate-antibody-antigen complex. The enzyme labeled antigen-antibody complex converts the added substrate to form a colored solution.
The rate of color formation from the chromogen is a function of the amount of conjugate complexed with the bound antibody and thus is proportional to the initial concentration of the respective antibodies in the patient sample.
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
Prescription 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:
- results obtained for clinically defined sera and for international reference sera.
- results obtained for samples from apparently healthy subjects (normal population).
- Results obtained within a comparison study analyzing 150 disease controls and 103 CTD samples.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
510(K) SUMMARY OF SAFETY AND 9. EFFECTIVENESS
MAR ] 3 2009
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: K083188
Date of Summary Preparation:
Manufacturer: Phadia GmbH Munzinger Strasse 7 D-79111 Freiburg, Germany Company 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: Varelisa ReCombi ANA Screen Common Name: Antinuclear antibody immunological test system
Classification
| Product Name | Product Code | Class | CFR |
|---|---|---|---|
| Varelisa® ReCombi ANA Screen | LJM | II | 866.5100 |
Substantial Equivalence to
Varelisa® ReCombi ANA Screen:
510(k) number: K993108
Page 41
CONFIDENTIAL AND PROPRIETARY
1
Intended Use Statement of the New Device
Intended use/Indication for use
The Varelisa ReCombi ANA Screen ElA kit is designed for the qualitative determination of eight antinuclear antibodies in human serum or plasma (citrate/EDTA) to aid in the diagnosis of systemic rheumatic diseases such as SLE (systemic lupus erythematosus), scleroderma (progressive systemic sclerosis), MCTD (mixed connective tissue disease), SS (Sjögren's syndrome) and polymyositis/ dermatomyositis. The Varelisa ReCombi ANA Screen detects antibodies against dsDNA, UIRNP (RNP70, A, C), Sm, SS-A/Ro (52 kDa,60 kDa), SS-B/La, Scl-70, CENP-B and Jo-1 in a single microwell.
Special condition for use statement
The device is for prescription use only.
Special instrument requirements
A microplate reader capable of measuring OD at 450 nm and 620 nm is required.
General Description of the New Device
The Varelisa ReCombi ANA Screen is an enzyme-linked immunosorbent assay (ELISA) for the qualitative determination of antinuclear antibodies in serum and plasma (citrate/EDTA). Designed as a screening assay, it detects eight antinuclear antibodies in a single microwell. The determination of antinuclear antibodies (ANA) is of central importance for the clinical diagnosis of rheumatic diseases. The presence of ANA suggests the possibility of rheumatic autoimmune diseases, These diseases include Systemic Lupus Erythemtosus (SLE), Polymyositis/ Dematomyositis, Scleroderma, Sjögren's Syndrome and Mixed Conective Tissue Diseases.
Test Principle of the New Device
Varelisa ReCombi ANA Screen is an indirect noncompetitive enzyme immunoassay for the qualitative determination of 8 antinuclear antibodies in serum or plasma (citrate/EDTA). The wells of a microplate are coated with human recombinant nuclear antigens, synthetic peptides and dsDNA. Antibodies specific for the nuclear antigens present in a patient sample bind to these nuclear antigens.
In a second step the enzyme labeled second antibody (conjugate) binds to the antigen-antibody complex which leads to the formation of an enzyme labeled conjugate-antibody-antigen complex. The enzyme labeled antigen-antibody complex converts the added substrate to form a colored solution.
The rate of color formation from the chromogen is a function of the amount of conjugate complexed with the bound antibody and thus is proportional to the initial concentration of the respective antibodies in the patient sample.
Device Comparison
The new device is developed as successor of the predicate device. Both assays share the same assay principle and indications for use. They are indirect
2
noncompetitive enzyme immunoassays for qualitative determination of IgG antibodies against antinuclear antigens in serum and plasma. Both assays recommend the same sample dilutions and use identical reagents (including the conjugate). In accordance to the relevant scientific literature both assays state in the Intended Use, that the measuring of antinuclear antibodies aids in the diagnosis of Connective Tissue Diseases such as SLE (systemic lupus erythematosus), scleroderma (progressive systemic sclerosis). MCTD (mixed connective tissue disease), SS (Sjögren's syndrome) and PM/DM (polymvositis/ dermatomyositis).
Differences do exist but do not affect the tenor of the "Intended Use" and do not raise new types of "Safety and Effectiveness" questions. The new device uses a synthetic peptide derived from the human SmD protein instead of Sm antigen purified from calf thymus. Minor differences pertain to increased volumina of the reagents and leaving out the prewashing step of the antigen strips. The Wash buffer no longer contains NaN3 and the substrate TMB is of lower concentration because the substrate incubation step has been increased to 30 min.
Laboratory equivalence
The comparability of predicate device and new device is supported by a data set including
- · results obtained for clinically defined sera and for international reference sera.
- · results obtained for samples from apparently healthy subjects (normal population).
- · Results obtained within a comparison study analyzing 150 disease controls and 103 CTD samples.
In summary, all available data support that the new device is substantially equivalent to the predicate device and that the new device performs according to state-of-the-art expectations.
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo features a stylized eagle with its wings spread, facing to the right. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
Public Health Service
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, Michigan 49002
MAR 1 3 2009
Re: K083188 Trade/Device Name: Varelisa ® ReCombi ANA Screen Regulation Number: 21 CFR 866.5100 Regulation Name: Antinuclear antibody immunological test system Regulatory Class: II Product Code: LJM Dated: October 24, 2008 Received: October 29, 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 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). You may, therefore, market the device, subject to the general controls provisions of the Act. However, you are responsible to determine that the medical devices you use as components in the [kit/tray] have either been determined as substantially equivalent under the premarket notification process (Section 510(k) of the act), or were legally on the market prior to May 28, 1976, the enactment date of the Medical Device Amendments. Please note: If you purchase your device components in bulk (i.e., unfinished) and further process (e.g., sterilize) you must submit a new 510(k) before including these components in your kit/tray. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, and 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 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.
4
Page 2- Mr. Mann
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); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 s rotty premainteted 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 the labeling regulation, 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 question 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 many obtain other general information on your responsibilities under the Act from the Division of Small Manufactuers, 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,
maria m chain
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
5
Indication for Use
510(k) Number (if known): K083188
Device Name:
Varelisa ReCombi ANA Screen
Indication For Use:
The Varelisa ReCombi ANA Screen EIA kit is designed for the qualitative determination of cight antinuclear antibodies in human serum or plasma to aid in the diagnosis of systemic rheumatic diseases such as SLE (systemic lupus erythematosus), scleroderma (progressive systemic sclerosis), MCTD (mixed connective tissue disease), SS (Sjögren's syndrome) and polymyositis/ dermatomyositis. The Varelisa ReCombi ANA Screen detects antibodies against dsDNA, U1RNP (RNP70, A, C), Sm, SS-A/Ro (52 kDa,60 kDa), SS-B/La, Scl-70, CENP-B and Jo-1 in a single microwell.
Prescription Use _ X (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)
im Chan
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) 083188