(15 days)
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No
The 510(k) summary describes a standard ELISA test for detecting antibodies and contains no mention of AI, ML, or related concepts.
No
The device is an in vitro diagnostic test designed to detect antinuclear antibodies in human serum to aid in the determination of autoimmune diseases, not to treat them.
Yes
The 'Intended Use / Indications for Use' section explicitly states that the device is "intended for in vitro diagnostic use as an aid in the determination of certain autoimmune diseases." This phrase clearly indicates its role in diagnosing diseases.
No
The device is an in vitro diagnostic test, which is a physical kit used to analyze biological samples, not a software-only device.
Yes, based on the provided information, the RhiGene MESACUP ANA TEST is an IVD (In Vitro Diagnostic) device.
The "Intended Use / Indications for Use" section explicitly states:
- "The RhiGene MESACUP ANA TEST is a semi-quantitative enzyme-linked immunosorbent assay for the detection of disease specific antinuclear antibodies in human serum." This describes a test performed on a biological sample (human serum) outside of the body.
- "The RhiGene MESACUP ANA TEST is intended for in vitro diagnostic use as an aid in the determination of certain autoimmune diseases." This directly states the intended use is "in vitro diagnostic use."
These statements clearly align with the definition of an In Vitro Diagnostic device, which is used to examine specimens taken from the human body to provide information for diagnosis, monitoring, or screening.
N/A
Intended Use / Indications for Use
The RhiGene MESACUP ANA TEST is a semi-quantitative enzyme-linked immunosorbent assay for the detection of disease specific antinuclear antibodies in human serum. The RhiGene MESACUP ANA TEST is intended for in vitro diagnostic use as an aid in the determination of certain autoimmune diseases.
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
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Key Metrics
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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 U.S. Department of Health & Human Services. The seal features a stylized eagle-like symbol with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the symbol.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Yusuke Kobe Vice President RhiGene, Inc. 455 State Street. Suite 104 Des Plaines, Illinois 60016
பாட 5 2002
Re: K022018
Trade/Device Name: RhiGene MESACUP ANA TEST Regulation Number: 21 CFR § 866.5100 Regulation Name: Immunological Test System Regulatory Class: II Product Code: LJM Dated: June 18, 2002 Received: June 20, 2002
Dear Yusuke Kobe:
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 (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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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" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained 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.gov/cdrh/dsma/dsmamain.html".
Sincerely yours,
Steven Butman
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
2
Indications for Use Statement
K022018 ----------------------------------------------------------------------------------------------------------------------------------------------------------------------510(k) Number:_
Device Name: RhiGene MESACUP ANA TEST
Indications for Use:
The RhiGene MESACUP ANA TEST is a semi-quantitative enzyme-linked immunosorbent assay for the detection of disease specific antinuclear antibodies in human serum. The RhiGene MESACUP ANA TEST is intended for in vitro diagnostic use as an aid in the determination of certain autoimmune diseases.
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Concurrence of CDRH, Office of Device Evaluation (ODE)
A Reeves for S. Actai
OR
(Division Sign-Off) Division of Clinical Laboratory Devices 510(k) Number -
Prescription Use (Per 21 CFR 801.109) Over-The-Counter Use --
(Optional Format 1-2-96)