(35 days)
An enzyme-linked immunosorbant assay for the semi-quantitative detection of anti-nuclear antibodies (ANA) in human serum. The presence of ANA can be used in conjunction with clinical findings and other laboratory tests to aid in the diagnosis of rheumatic diseases such as systemic lupus erythematosus, Sjögren's syndrome, scleroderma, and mixed connective tissue disease. The assay collectively detects, in one well, total ANA against chromatin (dsDNA and histones), Sm/RNP, SS-A, SS-B, Scl-70, centromere, and PCNA as well as antibodies against diagnostically important cytoplasmic antigens such as Jo-1, mitochondria (M-2) and ribosomal-P protein. Sera positive for unidentified antigens by the traditional indirect immunofluorescent antibody test on HEp-2 cells may also be detected.
Not Found
I am sorry, but the provided text does not contain the detailed information necessary to describe the acceptance criteria and the study that proves the device meets those criteria, as requested in the prompt. The document is an FDA 510(k) clearance letter for the QUANTA Lite™ ANA ELISA device, which confirms substantial equivalence to a predicate device. While it mentions the intended use of the device, it does not include specifics about:
- A table of acceptance criteria and reported device performance.
- Sample sizes or data provenance for a test set.
- Number or qualifications of experts for ground truth.
- Adjudication methods.
- Multi-reader multi-case comparative effectiveness studies or effect sizes.
- Standalone algorithm performance.
- Type of ground truth used.
- Sample size for the training set.
- How ground truth for the training set was established.
This letter primarily serves as a regulatory approval notice, not a detailed technical report of device validation.
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Food and Drug Administration 2098 Gaither Road Rockville MD 20850
JUN 17 1999
Mr. Brys C. Myers Manager, Regulatory Affairs INOVA Diagnostics, Inc. 10180 Scripps Ranch Boulevard San Diego, California 92131
Re: K991657 Trade Name: QUANTA Lite™ ANA ELISA Regulatory Class: II Product Code: LLL Dated: May 12, 1999 Received: May 13, 1999
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 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 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/cdrl/dsma/dsmamain.html".
Sincerely yours,
Steven Sutman
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 99 16 5 7
Device Name: QUANTA Lite™ ANA ELISA
Indications For Use:
An enzyme-linked immunosorbant assay for the semi-quantitative detection of anti-nuclear antibodies (ANA) in human serum. The presence of ANA can be used in conjunction with clinical findings and other laboratory tests to aid in the diagnosis of rheumatic diseases such as systemic lupus erythematosus, Sjögren's syndrome, scleroderma, and mixed connective tissue disease. The assay collectively detects, in one well, total ANA against chromatin (dsDNA and histones), Sm/RNP, SS-A, SS-B, Scl-70, centromere, and PCNA as well as antibodies against diagnostically important cytoplasmic antigens such as Jo-1, mitochondria (M-2) and ribosomal-P protein. Sera positive for unidentified antigens by the traditional indirect immunofluorescent antibody test on HEp-2 cells may also be detected.
Peter E. Malkan
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use $\checkmark$
§ 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).