(135 days)
Enzyme linked immunosorbent assay method for the semi-quantitative determination of specific IgA rheumatoid factor (RF) antibodies in human serum.
Uses:
The results of the RF IgA assay can be used as an aid in the diagnosis of rheumatoid arthritis (RA) when supported by other laboratory and clinical investigations.
Levels of these autoantibodies are one indicator in a multi-factorial diagnostic regime.
The assay may be used on the Hycor Hy. Tec Automated EIA instrument.
For in vitro diagnostic use only.
Not Found
The provided text is a 510(k) clearance letter for the "Autostat II Rheumatoid Factor IgA ELISA" device, indicating it has been deemed substantially equivalent to a legally marketed predicate device. This document primarily focuses on regulatory approval and does not contain detailed information about specific acceptance criteria or the study data that proved the device met those criteria.
Therefore, most of the requested information cannot be extracted from the given text. The relevant sections from the prompt that can be addressed from the text are the device name and its intended use.
Here's a breakdown of what can and cannot be answered:
1. A table of acceptance criteria and the reported device performance
- Cannot be answered from the provided text. The letter states the device is "substantially equivalent" to a predicate device, but it does not specify the performance acceptance criteria or report the actual performance metrics of the Autostat II Rheumatoid Factor IgA ELISA.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Cannot be answered from the provided text. The document does not describe the test set size or its provenance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Cannot be answered from the provided text. This information would typically be in a study report, not a regulatory clearance letter.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Cannot be answered from the provided text. This detail is not present.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Cannot be answered from the provided text. This device is an ELISA (Enzyme-linked immunosorbent assay), a laboratory diagnostic test, not an image-based device that would typically involve human readers or AI assistance in the way described for MRMC studies.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Partially addressed indirectly. As an ELISA test, its performance is typically "standalone" in that it produces a result without direct human interpretation in the same way an imaging AI might. However, the document doesn't explicitly state whether a standalone performance study was conducted or its results.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Cannot be answered from the provided text. While the device aids in the diagnosis of rheumatoid arthritis, the method used to establish the ground truth in any underlying studies is not disclosed.
8. The sample size for the training set
- Cannot be answered from the provided text. This information is not included.
9. How the ground truth for the training set was established
- Cannot be answered from the provided text. This information is not included.
Based on the provided text, here's what can be stated:
- Device Name: Autostat II Rheumatoid Factor IgA ELISA (also referred to as Autostat Rheumatoid Factor IgA ELISA)
- Indications for Use: Enzyme linked immunosorbent assay method for the semi-quantitative determination of specific IgA rheumatoid factor (RF) antibodies in human serum.
- Uses: The results of the RF IgA assay can be used as an aid in the diagnosis of rheumatoid arthritis (RA) when supported by other laboratory and clinical investigations. Levels of these autoantibodies are one indicator in a multi-factorial diagnostic regime. The assay may be used on the Hycor Hy. Tec Automated EIA instrument. For in vitro diagnostic use only.
- Regulatory Status: Cleared by FDA on March 3, 2000, under K993557, as substantially equivalent to a legally marketed predicate device.
To obtain the detailed study information regarding acceptance criteria, sample sizes, ground truth establishment, and performance metrics, one would typically need to refer to the full 510(k) submission summary or a separate study report, which is not included here.
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Image /page/0/Picture/1 description: The image is a black and white circular logo for the Department of Health & Human Services USA. The logo features the department's emblem, which is a stylized caduceus with three snakes intertwined around a staff. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper half of the circle, following its curvature.
MAR - 3 2000
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Ms. Danielle M. Knight Ouality Manager Cogent Diagnostics Limited Pentlands Science Park Bush Loan, Penicuik EH26 OPL Scotland, United Kingdom
Re: K993557
Trade Name: Autostat II Rheumatoid Factor IgA ELISA Regulatory Class: II Product Code: DHR Dated: February 7, 2000 Received: February 10, 2000
Dear Ms. Knight:
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 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 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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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 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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Page of
| Labels | Values |
|---|---|
| 510(k) Number (if known) | K993557 |
| Device Name | Autostat |
| Rheumatoid Factor IgA ELISA |
Indications For Use:
Enzyme linked immunosorbent assay method for the semi-quantitative determination of specific IgA rheumatoid factor (RF) antibodies in human serum.
Uses:
The results of the RF IgA assay can be used as an aid in the diagnosis of rheumatoid arthritis (RA) when supported by other laboratory and clinical investigations.
Levels of these autoantibodies are one indicator in a multi-factorial diagnostic regime.
The assay may be used on the Hycor Hy. Tec Automated EIA instrument.
For in vitro diagnostic use only.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division
of
Serial Number = K 493554
Prescription Use Y (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).