(54 days)
The presence of autoantibodies to a number of nuclear constituents has proven to be useful in the diagnosis of various connective tissue diseases. Although the exact etiology of autoimmune diseases is unknown, and the specific role played by autoantibodies in the onset of various autoimmune connective tissue diseases is obscure, the association and frequency of detection of these antibodies may play a key role in the diagnostic work-up of patients with suspected connective tissue diseases.
The ANA Screen ELISA test system is intended for the manual or automated analysis of human serum for the presence or absence of IgG antibodies to a variety of nuclear antigens such as those directed against double stranded DNA, Jo-1. Sm. Sm/RNP. SSA. SSB. and Scl-70. The test system is also capable of detecting ANA demonstrating the centromere, nucleolar, peripheral and spindle IFA patterns.
Not Found
I am unable to provide the specific details of the acceptance criteria and study that proves the device meets the acceptance criteria based on the provided document. The document is a 510(k) clearance letter for the "Aptus (Automated) Application for the ANA Screen ELISA Test System" and an "Indications for Use" statement.
While it confirms the device's clearance and its intended use, it does not contain the detailed data, study designs, or acceptance criteria that would typically be found in a submission summary, clinical study report, or a more comprehensive technical document.
The document states that the FDA has "reviewed your Section 510(k) notification of intent to market the device" and "determined the device is substantially equivalent...". This determination is based on the information provided by the manufacturer in their 510(k) submission, which would have included data to support the claims of substantial equivalence. However, that underlying data and the specific acceptance criteria are not present in these pages.
Therefore, I cannot extract the following information from the provided text:
- A table of acceptance criteria and the reported device performance: This information is not provided.
- Sample size used for the test set and the data provenance: Not mentioned.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not mentioned.
- Adjudication method for the test set: Not mentioned.
- If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not mentioned. The device is referred to as an "Automated Application" for an ELISA test system, which generally implies a lab-based assay, not necessarily an AI-assisted diagnostic imaging or interpretation tool for human readers in the way an MRMC study would typically assess.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The "automated" aspect suggests standalone performance, but specific study details are not provided.
- The type of ground truth used: Not mentioned.
- The sample size for the training set: Not mentioned.
- How the ground truth for the training set was established: Not mentioned.
In summary, the provided document is a regulatory approval letter and indications for use, not a detailed technical report that describes the performance study.
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Image /page/0/Picture/2 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized depiction of three human profiles facing right, arranged in a stacked formation. The profiles are simple and abstract, with curved lines suggesting the shape of faces. The logo is surrounded by text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" in a circular arrangement.
NOV 1 8 1998
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Mr. Mark J. Kopnitsky Vice President of Research & Development Zeus Scientific, Inc. 200 Evans Way Branchburq, New Jersey 08876
Re: K983378 Aptus (Automated) Application for the ANA Screen Trade Name: Test System Requlatory Class: II Product Code: LJM Dated: September 22, 1998 September 25, 1998 Received:
Dear Mr. Kopnitsky:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 reqistration, listing of devices, qood manufacturing practice, labeling, and prohibitions aqainst misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Requlation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Reqister. Please note: this response to your premarket notification submission does not affect any obliqation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Page 2
This letter will allow you to beqin marketing your device as described in your 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.
If you desire specific advice for your device on our labeling requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers 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,
Steven Dutman
Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page ___ 1
510(k) Number (if known): K983378
Device Name: Aptus (automated) Application for the ANA Screen ELISA Test System
Indications for Use:
The presence of autoantibodies to a number of nuclear constituents has proven to be useful in the diagnosis of various connective tissue diseases. Although the exact etiology of autoimmune diseases is unknown, and the specific role played by autoantibodies in the onset of various autoimmune connective tissue diseases is obscure, the association and frequency of detection of these antibodies may play a key role in the diagnostic work-up of patients with suspected connective tissue diseases.
The ANA Screen ELISA test system is intended for the manual or automated analysis of human serum for the presence or absence of IgG antibodies to a variety of nuclear antigens such as those directed against double stranded DNA, Jo-1. Sm. Sm/RNP. SSA. SSB. and Scl-70. The test system is also capable of detecting ANA demonstrating the centromere, nucleolar, peripheral and spindle IFA patterns.
Peter E. Mofem
Division Sign-Off
(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use | ✓ |
|---|---|
| ------------------ | --- |
OR
Over-The-Counter Use
(Per 21 CFR 801,109)
2-96)
(Optional Format 1-
§ 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).