(147 days)
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No
The summary describes a rapid hemagglutination slide test, which is a traditional laboratory method and does not mention any computational or algorithmic components indicative of AI/ML.
No
The Rheumacol RF Test is a diagnostic test used to detect rheumatoid factor, which aids in the diagnosis of rheumatoid arthritis. It does not provide therapy or treatment.
Yes
The "Intended Use / Indications for Use" section states: "This test is used as an aid in the diagnosis of rheumatoid arthritis."
No
The device is described as a "rapid color enhanced hemagglutination slide test," which is a physical laboratory test kit, not a software application.
Based on the provided information, yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states that the Rheumacol RF Test is for the "detection of rheumatoid factor (RF) in serum." Serum is a biological sample taken from the body.
- Method: It's a "rapid color enhanced hemagglutination slide test," which is a laboratory technique performed in vitro (outside the living body) on the biological sample.
- Purpose: The test is used "as an aid in the diagnosis of rheumatoid arthritis," which is a medical condition.
These characteristics align perfectly with the definition of an In Vitro Diagnostic device, which is used to examine specimens taken from the human body to provide information for the diagnosis, monitoring, or treatment of a disease or condition.
N/A
Intended Use / Indications for Use
The Rheumacol RF Test is a rapid color enhanced hemagglutination slide test for the determination of the rheumatoid factor (RF) in serum. This test is used as an aid in the diagnosis of rheumatoid arthritis. This test is "For Professional Use Only".
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
"For Professional Use Only"
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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§ 866.5775 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
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
David Mycock Laboratory Director Immunostics, Inc. 3505 Sunset Avenue Ocean, NJ 07712
OV 2 5 1997 Re: K972456 Trade Name: Rheumacol Rheumatoid Factor Te Regulatory Class: II Product Code: DHR Dated: June 20, 1997 Received: July 1, 1997
Dear Mr. Mycock:
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 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 at (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html"
Sincerely yours,
Steven Autman
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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K972456 510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________
RHEUMACOL RF TEST Device Name:_
Indications for Use:
The Rheumacol RF Test is a rapid color enhanced hemagglutination slide test for the The Rhedmacor Nr 1758 is a rapia one. Online of the matoid factor (RF) in series in the used as an aid in the diagnosis of theumatoid arthritis. This test is "For Professional Use Only".
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|---|---|
| (Division Sign-Off) | |
| Division of Clinical Laboratory Devices | |
| 510(k) Number __________ |
| Prescription Use
| (Per 21 CFR 801.109) __________ | OR | Over-the-Counter Use __________ |
|---|---|---|
| ----------------------------------------------------- | ---- | --------------------------------- |
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