(72 days)
Not Found
No
The device description details a standard ELISA kit, and there is no mention of AI or ML in the device description, intended use, or performance studies.
No
This device is an in vitro diagnostic (IVD) kit used to detect antibodies for the diagnosis of a condition, not to treat or therapeutically intervene.
Yes
The device is described as aiding "in the diagnosis of systemic lupus erythematosus (SLE)," indicating its use in identifying or confirming a medical condition.
No
The device description clearly outlines a physical kit containing reagents, microtiter plates, and other laboratory components, indicating it is a hardware-based diagnostic assay, not software only.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's for the "determination of SmD antibodies in serum or plasma to aid in the diagnosis of systemic lupus erythematosus (SLE)." This involves testing biological samples (serum or plasma) in vitro (outside the body) to provide diagnostic information.
- Device Description: The description details an "enzyme-linked immunosorbent assay (ELISA)" which is a common laboratory technique performed in vitro to detect and quantify substances in biological samples.
- Components: The kit contains reagents like calibrators, controls, sample diluent, wash buffer, and stop solution, all of which are typical components of an IVD kit used for laboratory testing.
- Prescription Use Only: While not a definitive marker of an IVD, many IVDs are restricted to prescription use due to the need for trained personnel to perform the test and interpret the results in a clinical context.
The information provided clearly aligns with the definition and characteristics of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Varelisa Sm Antibodies EIA kit is designed for the semiquantitative and qualitative determination of SmD antibodies in serum or plasma to aid in the diagnosis of systemic lupus erythematosus (SLE).
Product codes (comma separated list FDA assigned to the subject device)
LKP
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 a synthetic SmD peptide as antigen, which allow anti-SmD antibodies to react with the immobilized antigen (sample). The conjugate is rabbit anti-human IgG horseradish peroxidase (HRP), which uses 3, 3'5, 5' tetramethylbenzidine dihydrochloride (TMB) as substrate. The kit contains a set of six calibrators, positive and negative controls. 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
Not Found
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 analyzing positive, equivocal and negative sera.
- · results obtained for clinically defined sera and for international reference 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 and that the new device performs according to state-of-the-art expectations.
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).
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: | K042629 |
|---|---|
| Date of Summary Preparation: | September 21, 2004 |
| Manufacturer: | Sweden Diagnostics (Germany) GmbH |
| Munzinger Strasse 7 | |
| D-79111 Freiburg, Germany | |
| Company Contact Person: | Sabine Klugbauer |
| Specialist, Regulatory Affairs | |
| Sweden Diagnostics (Germany) GmbH | |
| Munzinger Strasse 7 | |
| D-79111 Freiburg, Germany | |
| +49-761-47805-419(Phone) | |
| +49-761-47805-335 (Fax) | |
| Device Name: | Varelisa® Sm Antibodies |
| Common Name: | Antinuclear antibody |
| immunological test system |
Classification
| Product Name | Product Code | Class | CFR |
|---|---|---|---|
| Varelisa® Sm Antibodies | LKP | II | 866.5100 |
Substantial Equivalence to
Varelisa® Sm Antibodies (510(k) number: K000312)
1
Intended Use Statement of the New Device
Intended use/Indication for use
The Varelisa Sm Antibodies EIA kit is designed for the semiquantitative and qualitative determination of SmD antibodies in serum or plasma to aid in the diagnosis of systemic lupus erythematosus (SLE).
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 nm 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 a synthetic SmD peptide as antigen, which allow anti-SmD antibodies to react with the immobilized antigen (sample). The conjugate is rabbit anti-human IgG horseradish peroxidase (HRP), which uses 3, 3'5, 5' tetramethylbenzidine dihydrochloride (TMB) as substrate. The kit contains a set of six calibrators, positive and negative controls. The kit also contains sample diluent, wash buffer concentrate and stop solution.
Test Principle of the New Device
The new device is an indirect noncompetitive enzyme immunoassay for the semiquantitative and qualitative determination of SmD antibodies in human serum or plasma. The wells of a microplate are coated with a synthetic SmD peptide. Antibodies specific for SmD present in the patient sample bind to the antigen.
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 noncompetitive enzyme immunoassays for the semiquantitative and qualitative determination of IgG antibodies against Sm in serum and plasma. Both assays recommend the same sample dilutions and use identical reagents (including the conjugate). The evaluation of the assays is identical. In accordance to the relevant scientific literature both assays state in the Intended Use, that the measuring of antibodies against Sm provides aid in the diagnosis of systemic lupus erythematosus (SLE).
2
The new device is based on a synthetic peptide of the human SmD protein while the predicate device contains a native Sm protein isolated from calf thymus. Minor differences between the two devices pertain to the packaging size of the reagents and the leaving out of the prewashing step of the antigen strips.
Laboratory equivalence
The comparability of predicate device and new device is supported by a data set including
- · results obtained within a comparison study analyzing positive, equivocal and negative sera.
- · results obtained for clinically defined sera and for international reference 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 and that the new device performs according to state-of-the-art expectations.
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/12 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES U.S.A." arranged around the perimeter. Inside the circle is a stylized design featuring three abstract shapes that resemble birds in flight or flowing lines.
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
DEC - 8 2004
Sabine Klugbauer, Ph.D. Specialist, Regulatory Affairs Sweden Diagnostics (Germany) GmbH Munzinger Strasse 7 D-79111 Freiburg Germany
Re: K042629
Trade/Device Name: Varelisa® Sm Antibodies Regulation Number: 21 CFR 866.5100 Regulation Name: Antinuclear Antibodies Immunological Test Systems Regulatory Class: Class II Product Code: LKP Dated: September 21, 2004 Received: September 27, 2004
Dear Dr. Klugbauer:
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); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
4
Page 2 - Sabine Klugbauer, Ph.D.
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 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 advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-3084. 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.qov/cdrh/dsma/dsmamain.html
Sincerely yours.
Robert L. Becker Jr.
Robert L. Becker, Jr., M.D., Ph. Director Division of Immunology and Hematology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
5
Indications for Use
510(k) Number: K042629
Device Name:
Varelisa® Sm Antibodies
Indications For Use:
The Varelisa Sm Antibodies EIA kit is designed for the semiquantitative and qualitative determination of SmD antibodies in serum or plasma to aid in the diagnosis of systemic lupus erythematosus (SLE).
Maria Chan
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K042629
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)