(48 days)
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No
The summary describes an ELISA test system for detecting antibodies and an automated application for the test. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices. The focus is on a laboratory diagnostic test and its automation.
No
The device is described as an ELISA test system intended for the analysis of human serum for the presence or absence of IgG antibodies to Jo-1, which is useful in the diagnosis of connective tissue diseases. It is a diagnostic tool, not a therapeutic one that treats or prevents disease.
Yes
The "Intended Use / Indications for Use" section explicitly states that the presence of autoantibodies is "useful in the diagnosis of various connective tissue diseases" and that the detection of these antibodies "may play a key role in the diagnostic work-up of patients with suspected connective tissue diseases." The Jo-1 ELISA test system described is intended for the analysis of human serum for these antibodies.
No
The device description "Aptus (Automated) Application for the Jo-1 Test System" suggests a software component that interacts with or controls a "Jo-1 Test System," which is likely a hardware-based ELISA test system for analyzing human serum. The intended use also describes a laboratory test, which typically involves physical reagents and equipment. Therefore, it is not a software-only medical device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states that the device is for the "analysis of human serum for the presence or absence of IgG antibodies Jo-1." This analysis is performed in vitro (outside of the living body) on a biological sample (human serum) to provide information for the diagnosis of connective tissue diseases.
- Device Description: While the device description mentions an "Automated Application," the core function described in the intended use is a test system for analyzing a biological sample. ELISA (Enzyme-Linked Immunosorbent Assay) is a common in vitro diagnostic technique.
The key characteristic of an IVD is that it is used to examine specimens derived from the human body to provide information for diagnostic purposes. This device clearly fits that description.
N/A
Intended Use / Indications for Use
The Jo-1 ELISA test system is intended for the manual or automated analysis of human serum for the presence or absence of IgG antibodies Jo-1.
Product codes
LLL
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 shows the logo for the Department of Health & Human Services USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" written around the perimeter. Inside the circle is a symbol that resembles a stylized human figure. The figure is composed of three overlapping profiles, suggesting a sense of community and support.
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 Branchburg, New Jersey 08876
Re : K983464 Aptus (Automated) Application for the Jo-1 Test Trade Name: System Regulatory Class: II Product Code: LLL Dated: September 30, 1998 Received: October 1, 1998
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 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations 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 Regulation (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 obligation 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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This letter will allow you to begin 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 regulation (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.gov/cdrh/dsma/dsmamain.html".
Sincerely yours,
Steven Sutman
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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510(k) Number (if known): 598
Device Name: Aptus (automated) Application for the Jo-1 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 Jo-1 ELISA test system is intended for the manual or automated analysis of human serum for the presence or absence of IgG antibodies Jo-1.
Pitur E. Malini
(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
(Optional Format 1-
(Per 21 CFR 801,109)
2-96)