(345 days)
For the in-vitro measurement for of IgG autoantibodies against B2-glycoprotein 1 (B2GP1) present in human serum. This kit may be used in conjunction with anticardiolipin assays and clinical information to aid the diagnosis of thrombosis in at risk patients having, for example, antiphospholipid syndrome (APS) or systemic lupus erythematosus (SLE).
Not Found
I am sorry, but based on the provided document, I cannot extract the detailed information required to describe the acceptance criteria and the study that proves the device meets those criteria. The document is a 510(k) clearance letter from the FDA, which confirms the substantial equivalence of the Bindazyme® Anti-B2 GP1 IgG EIA Test Kit to a predicate device for its stated indications for use.
While the document identifies the device and its intended use, it does not contain any information about:
- Specific acceptance criteria (thresholds or metrics) for the device's performance.
- Results of a study detailing performance metrics like sensitivity, specificity, accuracy, etc.
- Sample sizes for test or training sets.
- Data provenance.
- Details about experts establishing ground truth or adjudication methods.
- Whether MRMC or standalone studies were performed.
- Types of ground truth used.
Essentially, this document is a regulatory approval notice, not a detailed technical report of a performance study. To answer your request, I would need a different type of document, such as a summary of safety and effectiveness, a clinical study report, or a comprehensive device manual that includes performance data.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle with three lines representing its wings and a wavy line representing its body. The logo is black and white.
MAY = 5 2000
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
The Binding Site c/o Mr. Jay H. Geller West Tower, Suite 4000 2425 West Olympic Boulevard Santa Monica, California 90404
Re: K991801
Trade Name: Bindazyme® Anti-B2 GP1 IgG EIA Test Kit Regulatory Class: II Product Code: MSV Dated: March 31, 2000 Received: April 4, 2000
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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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" (21CFR 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): K99180/
Device Name:__________________________________________________________________________________________________________________________________________________________________
Indications For Use:
INDICATIONS FOR USE STATEMENT
Device Name: Bindazyme® Anti-B2 GP1 IgG EIA Test Kit
Indications Use: For the in-vitro measurement for of IgG autoantibodies against B2-glycoprotein 1 (B2GP1) present in human This kit may be used in conjunction with anticardiolipin serum. assays and clinical information to aid the diagnosis of thrombosis in at risk patients having, for example, antiphospholipid syndrome (APS) or systemic lupus erythematosus (SLE) .
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Matem
(Division Sign-Off)
Division of Clinical Laboratory Devices Vogue
Prescription Use V (Per 21 CFR 801.109)
OR
Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)
§ 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).