(71 days)
Not Found
No
The device description and performance studies describe a standard ELISA assay, which is a biochemical test and does not involve AI/ML. There are no mentions of AI, ML, or related concepts.
No.
The device is an in vitro diagnostic (IVD) test designed to diagnose systemic rheumatic diseases by detecting antinuclear antibodies, not to treat them.
Yes
The "Intended Use / Indications for Use" section explicitly states that the kit is "designed for the qualitative determination of ten antinuclear antibodies in human serum or plasma to aid in the diagnosis of systemic rheumatic diseases". The phrase "aid in the diagnosis" directly indicates a diagnostic purpose.
No
The device description clearly states it is an enzyme-linked immunosorbent assay (ELISA) kit, which involves physical components like microtiter plates, reagents (conjugate, substrate, diluent, wash buffer, stop solution), calibrator, and negative control. This is a hardware-based diagnostic test, not a software-only device.
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 antibodies in human serum or plasma to aid in the diagnosis of systemic rheumatic diseases. This clearly indicates that the device is intended to be used in vitro (outside the body) to examine specimens from the human body for diagnostic purposes.
- Device Description: The description details an ELISA kit that uses human serum or plasma samples. This further confirms its use with biological specimens in vitro.
- Performance Studies: The summary of performance studies describes testing with clinically defined sera and samples from apparently healthy subjects, which are typical for evaluating the performance of an IVD.
N/A
Intended Use / Indications for Use
The Varelisa ReCombi CTD Screen EIA kit is designed for the qualitative determination of ten antinuclear antibodies in human serum or plasma to aid in the diagnosis of systemic rheumatic diseases such as SLE (systemic lupus erythematosus), drug-induced lupus, scleroderma (progressive systemic sclerosis), MCTD (mixed connective tissue disease), SS (Sjögren's syndrome) and polymyositis/dermatomyositis. The Varelisa ReCombi CTD Screen detects antibodies against dsDNA, RNP (RNP70,A,C), Sm (B,B',D), SS-A/Ro(52 kDa,60 kDa), SS-B/La, Scl-70, CENP-B, Histone, Ribosomal P Protein and Jo-1 in a single microwell.
Product codes (comma separated list FDA assigned to the subject device)
LJM
Device Description
The new device is an enzyme-linked immunosorbent assay (ELISA) using microtiter plates as the solid phase. The plate wells are coated with antinuclear antigens, which allow anti-nuclear antibodies (sample) to react with the immobilized antigens. The conjugate is rabbit anti-human IgG horseradish peroxidase (HRP), which uses 3, 3'5, 5' tetramethylbenzidine dihydrochloride (TMB) as substrate. The kit contains calibrator and negative control. The kit also contains sample diluent, wash buffer concentrate and stop solution.
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
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 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 100 . disease controls and 183 CTD samples.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Analysis of Agreement between individual test results and clinical definitions of samples.
CTD samples (Positive):
Varelisa ReCombi CTD Screen: Agreement 87.4%, 95% Confidence Interval (CI) 81.7 - 91.9%
Predicate Device: Agreement 85.2%, 95% CI 79.3 - 90.0%
Difference between assays (%): Varelisa ReC. CTD Screen - Predicate Device: 2.2, 95% CI -1.7 - 5.0%
Control samples (Negative):
Varelisa ReCombi CTD Screen: Agreement 79.0%, 95% CI 69.7 - 86.5%
Predicate Device: Agreement 84.0%, 95% CI 75.3 - 90.6%
Difference between assays (%): Varelisa ReC. CTD Screen - Predicate Device: - 5.0, 95% CI -11.8 - -0.2%
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
510(K) SUMMARY OF SAFETY AND 9. 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: | K050967 |
|---|---|
| Date of Summary Preparation: | June 15, 2005 |
| Manufacturer: | Sweden Diagnostics (Germany) GmbH |
| Munzinger Strasse 7 | |
| D-79111 Freiburg, Germany | |
| Company Contact Person: | Michael Linss |
| Manager, Compliance & Quality | |
| Sweden Diagnostics (Germany) GmbH | |
| Munzinger Strasse 7 | |
| D-79111 Freiburg, Germany | |
| +49-761-47805-310 (Phone) | |
| +49-761-47805-335 (Fax) | |
| Device Name: | Varelisa ReCombi CTD Screen |
| Common Name: | Antinuclear antibody |
| immunological test system |
Classification
| Product Name | Product Code | Class | CFR |
|---|---|---|---|
| Varelisa® ReCombi CTD Screen | LJM | II | 866.5100 |
Substantial Equivalence to
Varelisa® ReCombi ANA Screen (510(k) number: K993108)
1
Intended Use Statement of the New Device
Intended use/Indication for use
The Varelisa ReCombi CTD Screen EIA kit is designed for the qualitative determination of ten antinuclear antibodies in human serum or plasma to aid in the diagnosis of systemic rheumatic diseases such as SLE (systemic lupus erythematosus), drug-induced lupus, scleroderma (progressive systemic sclerosis), MCTD (mixed connective tissue disease), SS (Sjögren's syndrome) and polymyositis/dermatomyositis. The Varelisa ReCombi CTD Screen detects antibodies against dsDNA, RNP (RNP70,A,C), Sm (B,B',D), SS-A/Ro(52 kDa,60 kDa), SS-B/La, Scl-70, CENP-B, Histone, Ribosomal P Protein 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 mm and 620 mm is required.
General Description of the New Device
The new device is an enzyme-linked immunosorbent assay (ELISA) using microtiter plates as the solid phase. The plate wells are coated with antinuclear antigens, which allow anti-nuclear antibodies (sample) to react with the immobilized antigens. The conjugate is rabbit anti-human IgG horseradish peroxidase (HRP), which uses 3, 3'5, 5' tetramethylbenzidine dihydrochloride (TMB) as substrate. The kit contains calibrator and negative control. The kit also contains sample diluent, wash buffer concentrate and stop solution.
Test Principle of the New Device
Varelisa ReCombi CTD Screen is an indirect noncompetitive enzyme immunoassay for the qualitative determination of 10 antinuclear antibodies in serum or plasma. The wells of a microplate are coated with human recombinant and native purified nuclear antigens 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.
2
Device Comparison
The new device is developed as successor of the predicate device. Both assays the now assay principle and indications for use. They are indirect share the bains asseme immunoassays for qualitative determination of IgG antibodies against antinuclear antigens in serum and plasma. Both assays antioodies "agains" annote dilutions and use identical reagents (including the coolimions the bande 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 polymyositis/ dermatomyositis.
Differences do exist but do not affect the tenor of the "Intended Use" and do not Differences as entor Safety and Effectiveness" questions. The new device uses two additional antigens (Histone, Rib-P) and a synthetic peptide derived from the human SmD protein plus recombinant SmBB' instead of Sm antigen purified from calf thymus (complex consisting of SmBB' and SmD). Minor differences pertain to increased volumina of the reagents and leaving out the prewashing step of the antigen strips. The Wash buffer does no longer contain NaN3 and the substrate TMB is of lower concentration because the substrate incubation step is 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 100 . disease controls and 183 CTD samples.
Analysis of Agreement between individual test results and clinical definitions of samples.
| | Varelisa ReCombi CTD Screen | | Predicate Device | | Difference between
assays (%) | |
|----------------------------------|-----------------------------|---------------------------------|------------------|-----------------|---------------------------------------------------|------------------|
| | Agreement
(%) | 95% Confidence
Interval (CI) | Agreement
(%) | 95% CI | Varelisa ReC. CTD
Screen -
Predicate Device | 95% CI |
| Positive
(CTD
samples) | 87.4 | 81.7 - 91.9% | 85.2 | 79.3 -
90.0% | 2.2 | -1.7 -
5.0% |
| Negative
(Control
samples) | 79.0 | 69.7 - 86.5% | 84.0 | 75.3 -
90.6% | - 5.0 | -11.8 -
-0.2% |
3
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.
4
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administratio 2098 Gaither Road Rockville MD 20850
JUN 2 8 2005
Mr. Michael Linss Manager, Compliance and Quality Sweden Diagnostics (Germany) GmbH Munzinger Strasse 7 D-79111 Freiburg, Germany
K050967 Re:
Trade/Device Name: Varelisa ReCombi CTD Screen Regulation Number: 21 CFR 866.5100 Regulation Name: Antinuclear antibody immunological test system Regulatory Class: Class II Product Code: LJM Dated: April 15, 2005 Received: April 18, 2005
Dear Mr. Linss:
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 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 CFR Part 807); labeling (21 CFR Parts 801 and 809); 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.
5
Page 2 -
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) 276-0484. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html
Sincerely yours,
Robert Beckerh
Robert L. Becker, Jr., MD, P& Director Division of Immunology and Hematology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
6
Indications for Use
510(k) Number:
Device Name:
Varelisa ReCombi CTD Screen
Indications For Use:
The Varelisa ReCombi CTD Screen EIA kit is designed for the qualitative determination of ten antinuclear antibodies in human serum or plasma to addinathe diagnosis of systemic rheumatic diseases such as SLE (systemic ipus erythematosus), drug-induced lupus, scleroderma (progressive systemic sclerosis), MCTD (mixed connective tissue disease), SS (Sjögren's syndrome) and polynysitis/ dermatomyositis. The Varelisa ReCombi CTD Screen detects antibodies against dsDNA, RNP (RNP70,A,C), Sm (B,B',D), SS-A/Ro(52 kDa,60 kDa), SS-B/La, Scl-70, CENP-B, Histone, Ribosomal P Protein and Jo-1 in a single miorovell.
Prescription Use V (Part 21 CFR 801 Subpart D) AND/OR
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)
Mani Chow
Division Sign-Off
Office of In Vitro Dia Device Evaluation and
510(k) Ks50967