(81 days)
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Not Found
No
The summary describes a standard in vitro diagnostic test for detecting antibodies and does not mention any AI or ML components or functionalities.
No.
The device is an in vitro diagnostic test system used to aid in the diagnosis of rheumatoid arthritis, not to treat or alleviate a disease.
Yes
The "Intended Use / Indications for Use" section explicitly states that the test system "is intended to be used as aid in the diagnosis of rheumatoid arthritis" and "The test is for in vitro diagnostic use."
No
The 510(k) summary describes an in vitro diagnostic test system that detects antibodies in human serum. This inherently involves physical reagents and laboratory procedures, indicating it is not a software-only device.
Yes, based on the provided information, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states:
- "The test is for in vitro diagnostic use." This is a direct declaration that the device is intended for use outside of a living organism to diagnose a condition.
- "The Zeus Scientific, Inc. AtheNA Multi-Lyte™ Rheumatoid Factor IgM Test System is intended for the qualitative and quantitative detection of RF IgM class antibody in human serum." This describes the analysis of a biological sample (human serum) to detect a specific substance (RF IgM antibody).
- "The test system is intended to be used as aid in the diagnosis of rheumatoid arthritis." This indicates the purpose of the test is to assist in the diagnosis of a disease.
All of these points align with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Zeus Scientific, Inc. AtheNA Multi-Lyte™ Rheumatoid Factor IgM Test System is intended for the qualitative and quantitative detection of RF IgM class antibody in human serum. The test system is intended for the analysis of human serum for the presence of IgM RF. The test system is intended to be used as aid in the diagnosis of rheumatoid arthritis. The test is for in vitro diagnostic use.
Product codes
DHR
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
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 866.5775 Rheumatoid factor immunological test system.
(a)
Identification. A rheumatoid factor immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the rheumatoid factor (antibodies to immunoglobulins) in serum, other body fluids, and tissues. Measurement of rheumatoid factor may aid in the diagnosis of rheumatoid arthritis.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle, there is an abstract symbol that resembles an eagle or a bird in flight, composed of three curved lines.
FEB 27 2004
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Mr. Mark J. Kopnitsky Vice President, Research and Development Zeus Scientific, Inc. 200 Evans Way Branchburg, New Jersey 08876
Re: K033802 Trade/Device Name: AtheNA Multi-Lyte™ Rheumatoid Factor IgM Test System Regulation Number: 21 CFR § 866.5775 Regulation Name: Rheumatoid Factor Immunological Test System Regulatory Class: II Product Code: DHR Dated: December 3, 2003 Received: December 29, 2003
Dear Mr. Kopnitsky:
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 Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 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.
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If you desire specific information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 594-3084. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act 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,
Joseph L. Arblett
Joseph L. Hackett, Ph.D. Acting Director Division of Immunology and Hematology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
2
Indications for Use Form
(Appendix E)
510(k) Number (if known): Ko3 3802
AtheNA Multi-Lyte™ Rheumatoid Factor IgM Test System Device Name:
Indications for Use:
The Zeus Scientific, Inc. AtheNA Multi-Lyte™ Rheumatoid Factor IgM Test System is intended for the qualitative and quantitative detection of RF IgM class antibody in human serum. The test system is intended for the analysis of human serum for the presence of IgM RF. The test system is intended to be used as aid in the diagnosis of rheumatoid arthritis. The test is for in vitro diagnostic use.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use _ V
OR
Over-The-Counter Use
(Per 21 CFR 801,109)
(Optional Format 1-
2-96)
Maria Chan
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K03 3802