(62 days)
The Diastat anti-ß, Glycoprotein1 IgG Test is a semi-quantitative enzyme immunoassay for the detection, in human serum or plasma (citrate or EDTA anticoagulated), of the IgG class of autoantibodies specific for B,GP1 Antigen. The test is intended for use as an aid in the assessment of thrombotic risk in patients with autoimmune disease associated with thrombotic disorders such a primary anti-phospholipid syndrome, or secondary to Systemic Lupus Erythematosus. The test results are not definitive in isolation and represent one parameter in a multi-criterion diagnostic process. The option of a qualitative protocol is also available.
Not Found
The provided text is a 510(k) clearance letter for the Shield DIASTAT anti-B2 Glycoprotein 1 IgG (ELISA) Assay. It confirms the device's substantial equivalence to a legally marketed predicate device. However, this document does not contain the detailed information required to describe the acceptance criteria and the study that proves the device meets them.
Specifically, the document lacks:
- A table of acceptance criteria and reported device performance.
- Information on sample sizes, data provenance for test sets, and details about ground truth establishment.
- Details regarding expert involvement, adjudication methods, or MRMC comparative effectiveness studies.
- Results from standalone algorithm performance, or information about the training set.
The letter focuses on the regulatory clearance process and confirms that the device can be marketed based on its substantial equivalence. To answer your questions, one would need to access the actual 510(k) submission (K982879) which would contain the performance data and study details.
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Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle or bird design with three curved lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the bird symbol. The logo is presented in black and white.
OCT 1 5 1998
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Ms. Eileen McCafferty Requlatory Affairs Manager Shield Diagnostics Limited The Technoloqy Park Dundee DD2 1XA UK
Re: K982879 Shield DIASTAT anti-B2 Glycoprotein 1 IgG (ELISA) Trade Name: Assay Regulatory Class: II Product Code: MSV Dated: August 11, 1998 Received: August 14, 1998
Dear Ms. McCafferty:
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 leqally 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, qood 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 requlation (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 requlation (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, "Misbrandinq 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 Putman
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): NOT KNOWN - K 982879
DIASTAT anti- ß, GLYCOPROTEIN 1 IgG ELISA TEST Device Name:
Indications for Use: The Diastat anti-ß, Glycoprotein1 IgG Test is a semi-quantitative enzyme immunoassay for the detection, in human serum or plasma (citrate or EDTA anticoagulated), of the IgG class of autoantibodies specific for B,GP1 Antigen. The test is intended for use as an aid in the assessment of thrombotic risk in patients with autoimmune disease associated with thrombotic disorders such a primary anti-phospholipid syndrome, or secondary to Systemic Lupus Erythematosus. The test results are not definitive in isolation and represent one parameter in a multi-criterion diagnostic process. The option of a qualitative protocol is also available.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Peter G. Makem
(Division Sign-Off)
Division of Clinical Laboratory Devices K982879
510(k) Number __
Prescription Use______________________________________________________________________________________________________________________________________________________________ (Per 21 CFR 801. 109)
OR
Over-The -Counter Use_________________________________________________________________________________________________________________________________________________________
§ 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).