(34 days)
To aid in the diagnosis of systemic lupus erythematosus and related conditions.
Not Found
I am sorry, but the provided text does not contain the detailed information necessary to answer the request about acceptance criteria and the study that proves the device meets them. The document is an FDA 510(k) clearance letter for a diagnostic device, which confirms substantial equivalence but does not describe the specific performance studies, sample sizes, ground truth establishment, or expert qualifications that would typically be detailed in a submission summary or a scientific publication.
Therefore, I cannot extract the following information:
- A table of acceptance criteria and the reported device performance
- Sample sizes used for the test set and the data provenance
- Number of experts used to establish the ground truth for the test set and their qualifications
- Adjudication method for the test set
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, or the effect size of human readers improving with AI vs. without AI assistance. (Note: This is an in-vitro diagnostic, not an AI-based imaging device, so this question is likely not applicable)
- If a standalone (algorithm only) performance study was done. (Note: This is an in-vitro diagnostic, not an AI-based algorithm, so this question is likely not applicable)
- The type of ground truth used
- The sample size for the training set
- How the ground truth for the training set was established
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an image of an eagle with its wings spread, with three lines extending from the eagle's body. The eagle is facing to the left.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Marius Teodorescu, M.D., Ph.D. President and CEO TheraTest Laboratories 1111 North Main Street Lombard, Illinois 60148
MAR 1 1 2004
Re: K040291
Trade/Device Name: EL-ANA Profiles:anti-Chromatin Regulation Number: 21 CFR § 866.5100 Regulation Name: Antinuclear Antibody Immunological Test System Regulatory Class: II Product Code: LJM Dated: February 24, 2004 Received: February 27, 2004
Dear Dr. Teodorescu:
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. Arlett
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
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510(k) Number (if known) Devicc Name: EL-ANA Profiles: anti-Chromatin
Indications For Use:
ਸਾਰ ਸ਼ੁਰੂ ਕੀਤੀ ਸ
To aid in the diagnosis of systemic lupus erythematosus and related conditions.
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Approve for m. Chan
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number_________________________________________________________________________________________________________________________________________________________________
Prescription Use & (Per 2) CFR 801.109) OR
Over - The - Counter _________________________________________________________________________________________________________________________________________________________
Optional Format 1-2-96
§ 866.5100 Antinuclear antibody immunological test system.
(a)
Identification. An antinuclear antibody immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the autoimmune antibodies in serum, other body fluids, and tissues that react with cellular nuclear constituents (molecules present in the nucleus of a cell, such as ribonucleic acid, deoxyribonucleic acid, or nuclear proteins). The measurements aid in the diagnosis of systemic lupus erythematosus (a multisystem autoimmune disease in which antibodies attack the victim's own tissues), hepatitis (a liver disease), rheumatoid arthritis, Sjögren's syndrome (arthritis with inflammation of the eye, eyelid, and salivary glands), and systemic sclerosis (chronic hardening and shrinking of many body tissues).(b)
Classification. Class II (performance standards).