(49 days)
A semiquantitative enzyme linked immunoassay for use in screening n Beaugust for IgM rheumatoid factor (RF) antibodies. Detection of pacitires IgM antibodies is an aid in the diagnosis of rheumatoid arthritis (RA).
Not Found
This appears to be a 510(k) clearance letter from the FDA for a diagnostic test kit, not a study report for an AI-powered device. Therefore, the requested information regarding acceptance criteria, study design, and AI-specific metrics cannot be extracted from the provided text.
The document discusses:
- Device Name: QUANTA Lite™ RF IgM Test Kit
- Regulatory Class: II
- Product Code: DHR
- Indications For Use: A semiquantitative enzyme-linked immunoassay for use in screening for IgM rheumatoid factor (RF) antibodies. Detection of specific IgM antibodies is an aid in the diagnosis of rheumatoid arthritis (RA).
- Substantial Equivalence: The FDA's determination that the device is substantially equivalent to legally marketed predicate devices.
The text does not contain any details about clinical studies, acceptance criteria for performance metrics (like sensitivity, specificity, or accuracy), sample sizes for test sets, ground truth establishment, expert involvement, or any information related to AI or machine learning performance.
To answer your questions, a separate study report or clinical trial summary for the QUANTA Lite™ RF IgM Test Kit would be needed.
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Food and Drug Administration 2098 Gaither Road Rockville MD 20850
JUN 20 1997
Brys C. Myers Manager, Regulatory Affairs ... . . ....... INOVA Diagnostics, Inc. 10451 Roselle Street. San Diego, CA 92121
Re: K971614 Name: OUANTA Lite™ RF IgM Test Kit Regulatory Class: II Product Code: DHR Dated: April 30, 1997 Received: May 2, 1997
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 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 requirement, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (OS) 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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510(k) Number (if known):
Device Name: QUANTA Lite™ RF IgM Test Kit
Indications For Use:
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A semiquantitative enzyme linked immunoassay for use in screening n Beaugust for IgM rheumatoid factor (RF) antibodies. Detection of pacitires IgM antibodies is an aid in the diagnosis of rheumatoid arthritis (RA).
Peter E. Maskin
(Division Sign-Off) Division of Clinical Laboratory De 510(k) Number
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use -Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)
§ 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).