(61 days)
The Trinity Biotech Captia ENA Profile Enzyme-Linked Immunosorbent Assays (ELISA) is intended for the detection of antibodies to individually coated Smith, Sm/RNP, SS-A (Ro), SS-B (La), Scl-70 and Jo-1 in a single serum specimen. The results of the assay are to be used as an aid in the diagnosis of Systemic Lupus Erythematosis (SLE), scleroderma, Sjogren's syndrome (SS), or other systemic rheumatic diseases.
Not Found
This document is a 510(k) clearance letter from the FDA for a diagnostic device, not a study report. As such, it does not contain the detailed information required to describe acceptance criteria and a study proving device performance in the way a scientific publication or a full regulatory submission would.
Therefore, I cannot extract the requested information. The document focuses on regulatory approval, stating that the device is "substantially equivalent" to a legally marketed predicate device, rather than providing a detailed breakdown of a clinical study demonstrating its performance against specific acceptance criteria.
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JAN 1 2 2000
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Wayne A. Kvetkosky Regulatory Affairs Manager Trinity Biotech (USA) 2823 Girts Road Jamestown, New York 14702
Re: K993839
Trade Name: ENA Profile ELISA Test System Regulatory Class: II Product Code: LLL Dated: December 29, 1999 Received: December 30, 1999
Dear Mr. Kvetkosky:
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 (OS) 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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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 (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: Atot Known K 993839 Device Name: ENA Profile ELISA
Indications For Use: The Trinity Biotech Captia ENA Profile Enzyme-Linked Immunosorbent Assays (ELISA) is intended for the detection of antibodies to individually coated Smith, Sm/RNP, SS-A (Ro), SS-B (La), Scl-70 and Jo-1 in a single serum specimen. The results of the assay are to be used as an aid in the diagnosis of Systemic Lupus Erythematosis (SLE), scleroderma, Sjogren's syndrome (SS), or other systemic rheumatic diseases.
Peter E. Maher
Division Sign-Out
Division of Clinical Labo
510(k) Number
PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) ant-see-n-de-sen-sean-was-ed-sea-s-c-c-c-c-c-c-c-c-c-c-c-c-c-c-c-c-c-c-c-c-c-……………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use V (Per 21 CFR 801.109) OR
Over-The Counter Use (Optional Format 1-2-96)
14993839
§ 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).