(72 days)
An enzyme-linked immunosorbant assay (ELISA) for the semiquantitative detection of chromatin reactive antibodies In human serum. The presence of anti-chromatin antibodies can be used in conjunction with clinical findings and other laboratory tests to aid in the diagnosis of drug-induced lupus (DIL) and systemic lupus erythematosus (SLE).
Not Found
The provided document is a 510(k) clearance letter from the FDA for the QUANTA Lite™ Chromatin ELISA device. It confirms that the device is substantially equivalent to legally marketed predicate devices. However, this document does not contain specific acceptance criteria, performance data, or details about the study design (sample sizes, ground truth establishment, expert qualifications, etc.) that would typically be found in a study report or a more detailed FDA submission.
Therefore, I cannot directly answer your request using the provided text. The document focuses on the regulatory clearance based on substantial equivalence, not on a detailed presentation of performance data against acceptance criteria.
To answer your request, I would need a different type of document, such as:
- The 510(k) summary or full submission itself
- A clinical study report
- The device's Instructions For Use (IFU) or package insert, which often includes performance data.
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Image /page/0/Picture/2 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a stylized image of a caduceus, which is a symbol often associated with healthcare. The caduceus in the logo is depicted with a modern, abstract design.
OCT 7 1998
Mr. Brys C. Myers Manager, Regulatory Affairs INOVA Diagnostics, INC. 10180 Scripps Ranch Boulevard San Diego, California 92131
Re: K982603 Trade Name: QUANTA Lite™ Chromatin ELISA Regulatory Class : II Product Code: LLL Dated: July 23, 1998 Received: July 27, 1998
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 reqistration, 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 Requlation (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.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
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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" (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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Page 1 of 1
510(k) Number (if known): 1982(c03
QUANTA Lite™ Chromatin ELISA Device Name:
Indications For Use:
enzyme-linked immunosorbant assay (ELISA) An for the semiquantitative detection of chromatin reactive antibodies In human serum. The presence of anti-chromatin antibodies can be used in conjunction with clinical findings and other laboratory tests to aid in the diagnosis of drug-induced lupus (DIL) and systemic lupus erythematosus (SLE).
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation
Tita E. Machin
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number
Prescription Use_ (Per 21 CFR 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).