(54 days)
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No
The document describes an ELISA test system for detecting autoantibodies in serum, which is a laboratory assay and does not mention any AI/ML components or image processing.
No
The device is an in vitro diagnostic (IVD) test system intended for the analysis of human serum to detect the presence or absence of IgG antibodies. It is used for diagnostic purposes in the work-up of patients with suspected connective tissue diseases, not for therapeutic intervention.
Yes
The device is described as an "ANA Screen ELISA test system" intended for "the manual or automated analysis of human serum for the presence or absence of IgG antibodies to a variety of nuclear antigens." It states that the detection of these antibodies "may play a key role in the diagnostic work-up of patients with suspected connective tissue diseases," explicitly linking its use to diagnosis.
No
The device is described as an "ANA Screen ELISA test system," which is a laboratory assay involving physical reagents and equipment, not solely software.
Based on the provided information, yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
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Intended Use: The "Intended Use / Indications for Use" section explicitly states that the device is intended for the "analysis of human serum for the presence or absence of IgG antibodies to a variety of nuclear antigens". This analysis is performed in vitro (outside of the living body) on a biological sample (human serum) to provide information for the diagnosis of various connective tissue diseases.
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Nature of the Test: The description mentions an "ELISA test system". ELISA (Enzyme-Linked Immunosorbent Assay) is a common laboratory technique used to detect and quantify substances in biological samples, which is a hallmark of IVD devices.
Therefore, the device fits the definition of an In Vitro Diagnostic device.
N/A
Intended Use / 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.
Product codes
LJM
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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).
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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-