(107 days)
The in-vitro qualitative screening of IgA, IgG and IgM autoantibodies against cardiolipin present in human serum. It may be used in conjunction with other serological assays clinical information to aid in the diagnosis of and antiphospholipid syndrome (APS) or systemic lupus erythematosus (SLE) .
Not Found
I am sorry, but without a detailed study report excerpt, I cannot provide the specific information requested about acceptance criteria and device performance. The provided text is a 510(k) clearance letter from the FDA, which confirms the device has been deemed substantially equivalent to a predicate device but does not contain the detailed study results or acceptance criteria used to support that determination.
To answer your questions, I would need a section from a study report that includes:
- A table of acceptance criteria and the reported device performance.
- Sample sizes used for the test set and data provenance.
- Number of experts and their qualifications for ground truth establishment.
- Adjudication method for the test set.
- Information on any MRMC comparative effectiveness study and its effect size.
- Confirmation of whether a standalone study was done.
- The type of ground truth used.
- The sample size for the training set (if applicable to an AI device).
- How the ground truth for the training set was established.
The provided document only states the device name, its indications for use, and confirms FDA clearance based on substantial equivalence. It does not include the detailed performance data or study design elements required.
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Public Health Service
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FEB | 999
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
The Binding Site, Limited C/O Mr. Jay H. Geller East Tower, Suite 600 2425 West Olympic Boulevard Santa Monica, California 90404
Re: K983695
Trade Name: Anticardiolipin IgGAM Screen EIA Kit Regulatory Class: II Product Code: MID Dated: January 12, 1999 Received: January 20, 1999
Dear Mr. Geller:
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/cdrh/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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Device Name: BINDAZYME® Anticardiolipin IgGAM Screen EIA Kit
Indications for Use: The in-vitro qualitative screening of IgA,
IgG and IgM autoantibodies against cardiolipin present in human serum. It may be used in conjunction with other serological assays clinical information to aid in the diagnosis of and antiphospholipid syndrome (APS) or systemic lupus erythematosus (SLE) .
Peter E. Makim
(Division Sign-Off) Division of Clinical Laboratory Devices 510(k) Number
§ 866.5660 Multiple autoantibodies immunological test system.
(a)
Identification. A multiple autoantibodies immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the autoantibodies (antibodies produced against the body's own tissues) in serum and other body fluids. Measurement of multiple autoantibodies aids in the diagnosis of autoimmune disorders (disease produced when the body's own tissues are injured by autoantibodies).(b)
Classification. Class II (performance standards).