(62 days)
The QUANTA Lite™ RF IgA ELISA is a semiquantitative enzymelinked immunosorbent assay (ELISA) for the detection of IgA rheumatoid factor (RF) antibodies in patient sera. The presence of these antibodies, when considered in conjunction with other laboratory and clinical findings, 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 device, the QUANTA Lite™ RF IgA ELISA. This type of document typically does not contain the detailed study information required to answer your specific questions about acceptance criteria, sample sizes, ground truth establishment, or multi-reader multi-case studies.
The FDA 510(k) clearance process primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than requiring extensive de novo clinical trials with detailed performance metrics and reader studies as might be found for a new, high-risk device.
Therefore, I cannot provide the requested information from the provided text.
Here's why and what kind of document would contain this information:
- Acceptance Criteria and Device Performance Table: This would be found in a comprehensive clinical study report, a validation study report, or potentially within the detailed 'Device Description' or 'Performance Data' sections of a full 510(k) submission, but not usually in the summary clearance letter itself.
- Sample Size, Data Provenance, Expert Qualifications, Adjudication Method, MRMC Studies, Standalone Performance, Ground Truth Type, Training Set Size, Training Ground Truth: All these details are specific to the design and execution of performance studies (clinical and analytical) and would be thoroughly documented in the full 510(k) submission's "Performance Data" or "Clinical Studies" sections. The clearance letter only summarizes the outcome of the FDA's review.
To get the information you are asking for, you would typically need to review the full 510(k) submission document itself, which is often much more extensive than the public clearance letter. Some submissions are available through the FDA's databases, but their level of detail can vary.
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4 1998 NOV
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Mr. Brys C. Myers Manager, Regulatory Affairs INOVA Diagnostics, Inc. 10180 Scripps Ranch Boulevard San Diego, California 92131-1234
K983084 Re : Trade Name: QUANTA Lite™ RF IgA ELISA Requlatory Class: II Product Code: DHR September 2, 1998 Dated: Received: September 3, 1998
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 aqainst 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 Requlations, 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 requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Reqister. 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 requlations.
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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" (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/cdrh/dsma/dsmamain.html".
Sincerely yours,
Steven Toutman
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): K 983084
Device Name: QUANTA Lite™ RF IgA ELISA
Indications For Use:
The QUANTA Lite™ RF IgA ELISA is a semiquantitative enzymelinked immunosorbent assay (ELISA) for the detection of IgA rheumatoid factor (RF) antibodies in patient sera. The presence of these antibodies, when considered in conjunction with other laboratory and clinical findings, is an aid in the diagnosis of rheumatoid arthritis (RA).
(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 | K983084 |
| Prescription Use | OR | Over-The-Counter Use |
|---|---|---|
| (Per 21 CFR 801.109) | (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).