(35 days)
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No
The summary describes a traditional immunoassay (ELISA) for detecting antibodies. There is no mention of AI, ML, image processing, or any computational analysis that would suggest the use of such technologies.
No
This device is an in vitro diagnostic assay used for the detection of anti-nuclear antibodies to aid in the diagnosis of certain diseases. It is not intended for treating or preventing diseases or conditions.
Yes
The device is described as an aid in "the diagnosis of rheumatic diseases" and detects "antibodies against diagnostically important cytoplasmic antigens", indicating its use in diagnosing medical conditions.
No
The device description is not found, but the intended use clearly describes an enzyme-linked immunosorbant assay, which is a laboratory test involving physical reagents and equipment, not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is an "enzyme-linked immunosorbant assay for the semi-quantitative detection of anti-nuclear antibodies (ANA) in human serum." This indicates that the device is used to examine a sample taken from the human body (serum) in vitro (outside the body) to obtain information about a person's health.
- Purpose: The purpose is to "aid in the diagnosis of rheumatic diseases." This is a diagnostic purpose, which is a key characteristic of IVDs.
The definition of an IVD generally includes devices used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device fits that description perfectly.
N/A
Intended Use / Indications for Use
An enzyme-linked immunosorbant assay for the semi-quantitative detection of anti-nuclear antibodies (ANA) in human serum. The presence of ANA can be used in conjunction with clinical findings and other laboratory tests to aid in the diagnosis of rheumatic diseases such as systemic lupus erythematosus, Sjögren's syndrome, scleroderma, and mixed connective tissue disease. The assay collectively detects, in one well, total ANA against chromatin (dsDNA and histones), Sm/RNP, SS-A, SS-B, Scl-70, centromere, and PCNA as well as antibodies against diagnostically important cytoplasmic antigens such as Jo-1, mitochondria (M-2) and ribosomal-P protein. Sera positive for unidentified antigens by the traditional indirect immunofluorescent antibody test on HEp-2 cells may also be detected.
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).
0
Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with three stripes representing the three branches of government. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
JUN 17 1999
Mr. Brys C. Myers Manager, Regulatory Affairs INOVA Diagnostics, Inc. 10180 Scripps Ranch Boulevard San Diego, California 92131
Re: K991657 Trade Name: QUANTA Lite™ ANA ELISA Regulatory Class: II Product Code: LLL Dated: May 12, 1999 Received: May 13, 1999
Dear Mr. Myers:
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 Regulations, 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 regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. 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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Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at (770) 488-7655.
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/cdrl/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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Page of
510(k) Number (if known): K 99 16 5 7
Device Name: QUANTA Lite™ ANA ELISA
Indications For Use:
An enzyme-linked immunosorbant assay for the semi-quantitative detection of anti-nuclear antibodies (ANA) in human serum. The presence of ANA can be used in conjunction with clinical findings and other laboratory tests to aid in the diagnosis of rheumatic diseases such as systemic lupus erythematosus, Sjögren's syndrome, scleroderma, and mixed connective tissue disease. The assay collectively detects, in one well, total ANA against chromatin (dsDNA and histones), Sm/RNP, SS-A, SS-B, Scl-70, centromere, and PCNA as well as antibodies against diagnostically important cytoplasmic antigens such as Jo-1, mitochondria (M-2) and ribosomal-P protein. Sera positive for unidentified antigens by the traditional indirect immunofluorescent antibody test on HEp-2 cells may also be detected.
Peter E. Malkan
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use $\checkmark$