SHIELD DIASTAT ANTI-B2 GLYCOPROTEIN 1 IGG (ELISA) ASSAY

K982879 · Shield Diagnostics, Ltd. · MSV · Oct 15, 1998 · Immunology

Device Facts

• Record ID: K982879
• Device Name: SHIELD DIASTAT ANTI-B2 GLYCOPROTEIN 1 IGG (ELISA) ASSAY
• Applicant: Shield Diagnostics, Ltd.
• Product Code: MSV · Immunology
• Decision Date: Oct 15, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.5660
• Device Class: Class 2

Intended 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.

Device Story

Diastat anti-ß2 Glycoprotein 1 IgG is an enzyme-linked immunosorbent assay (ELISA) for detecting IgG autoantibodies against ß2-glycoprotein 1 in human serum or plasma. Performed in clinical laboratory settings by trained personnel. Input: patient serum/plasma samples. Process: antigen-coated wells capture specific IgG antibodies; enzyme-conjugated secondary antibodies and substrate produce colorimetric signal proportional to antibody concentration. Output: semi-quantitative or qualitative results. Results serve as one parameter in multi-criterion diagnostic process for assessing thrombotic risk in autoimmune patients. Clinical utility: aids clinicians in evaluating patients with suspected anti-phospholipid syndrome or Systemic Lupus Erythematosus.

Clinical Evidence

No clinical data provided in the document; bench testing only.

Technological Characteristics

Enzyme-linked immunosorbent assay (ELISA) for in vitro diagnostic use. Utilizes antigen-coated microtiter plates for detection of IgG autoantibodies. Semi-quantitative or qualitative output based on colorimetric detection. Class II device.

Indications for Use

Indicated for patients with autoimmune disease associated with thrombotic disorders, including primary anti-phospholipid syndrome or secondary to Systemic Lupus Erythematosus, to aid in the assessment of thrombotic risk.

Regulatory Classification

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).

Submission Summary (Full Text)

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## 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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone], 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_________________________________________________________________________________________________________________________________________________________