(56 days)
The TheraTest EL-ANA Profiles: EL-ENA/5 is an in vitro diagnostic test for the screening of autoantibodies in human serum directed against the following extractable nuclear antigens: Sm, nRNP, SSA, SSB and Scl70. This screening aids in the diagnosis of systemic lupus erythematosus and related autoimmune disorders.
Not Found
I am sorry, but the provided text does not contain the detailed information necessary to answer your request about acceptance criteria and the study proving device performance. The document is a 510(k) clearance letter from the FDA for a device called "EL-ANA Profiles: EL-ENA/5." It primarily focuses on the regulatory clearance for marketing the device based on substantial equivalence to a predicate device.
The letter does not include:
- A table of acceptance criteria or reported device performance metrics.
- Details about sample sizes for test or training sets.
- Information on data provenance.
- The number or qualifications of experts used for ground truth.
- Adjudication methods.
- Whether a multi-reader multi-case (MRMC) comparative effectiveness study was done.
- Whether a standalone algorithm performance study was conducted.
- The type of ground truth used or how it was established for training data.
The relevant section for performance would typically be in the 510(k) submission itself, which is not provided here. The clearance letter only provides the "Indications for Use" and the determination of substantial equivalence.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/10 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, resembling a bird-like shape.
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
AUG / 3 1998
Marius Teodorescu, M.D., Ph.D. President and CEO TheraTest Laboratories, Inc. 2201 W. Campbell Park Drive Chicago, Illinois 60612-3501
Re : K982622 EL-ANA Profiles: EL-ENA/5 Trade Name: Regulatory Class: II Product Code: LLL Dated: June 9, 1998 Received: June 18, 1998
Dear Dr. Teodorescu:
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, Druq, 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 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 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 requlation 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 Butman
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) K982622 Device Name: EL-ANA Profiles: EL-ENA/5
Indications for Use: The TheraTest EL-ANA Profiles: EL-ENA/5_is an in vitro diagnostic test for the screening of autoantibodies in human serum directed against the following extractable nuclear antigens: Sm, nRNP, SSA, SSB and Scl70. This screening aids in the diagnosis of systemic lupus erythematosus and related autoimmune disorders.
Peter E. Maker
ISTISION Sign-Off Unision of Clinical 510(k) Number
(PLEASE DO WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGETE NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription use (Per 21CFR 801.109)
OR
Over-the-Counter use
(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).