ANTI-CARDIOLIPIN ANTIBODY (ACA) SCREEN ELISA

K970177 · Immco Diagnostics, Inc. · MID · Jun 11, 1997 · Immunology

Device Facts

• Record ID: K970177
• Device Name: ANTI-CARDIOLIPIN ANTIBODY (ACA) SCREEN ELISA
• Applicant: Immco Diagnostics, Inc.
• Product Code: MID · Immunology
• Decision Date: Jun 11, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.5660
• Device Class: Class 2

Intended Use

An enzyme linked immunoassay (ELISA) for the detection of IgG, IgA, IgM class anti-cardiolipin antibodies, as an aid in assessing the risk of thrombosis in individuals with anti-phospholipid syndrome.

Device Story

The Anti-Cardiolipin Antibody (ACA) Screen ELISA is an in vitro diagnostic device used in clinical laboratories. It detects IgG, IgA, and IgM class anti-cardiolipin antibodies in patient serum samples. The device utilizes enzyme-linked immunosorbent assay (ELISA) technology to identify these antibodies. Results are interpreted by healthcare professionals to aid in assessing the risk of thrombosis in patients suspected of having anti-phospholipid syndrome. The test provides qualitative or semi-quantitative data that supports clinical decision-making regarding patient management and risk stratification for thrombotic events.

Clinical Evidence

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

Technological Characteristics

Enzyme-linked immunosorbent assay (ELISA) for detection of IgG, IgA, and IgM antibodies. In vitro diagnostic test format.

Indications for Use

Indicated for the detection of IgG, IgA, and IgM class anti-cardiolipin antibodies in individuals to aid in assessing the risk of thrombosis associated with anti-phospholipid syndrome.

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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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration
2098 Gaither Road
Rockville MD 20850
JUN 11 1997

Mr. Richard E. Greco, R.A.C.
Regulatory Affairs
IMMCO Diagnostics, Inc.
965 Kenmore Avenue
Buffalo, New York 14223

Re: K970177/S2
* Trade Name: Anti-Cardiolipin Antibody (ACA) Screen ELISA
Regulatory Class: II
Product Code: MID
Dated: May 30, 1997
Received: June 5, 1997

Dear Mr. Greco:

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 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 Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP 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.

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 [phone].

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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 [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, "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 [phone] or at [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html"

Sincerely yours,

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): K970177

Device Name: Anti-Cardiolipin Antibody (ACA) Screen

Indications For Use:

An enzyme linked immunoassay (ELISA) for the detection of IgG, IgA, IgM class anti-cardiolipin antibodies, as an aid in assessing the risk of thrombosis in individuals with anti-phospholipid syndrome.


(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use ☑
(Per 21 CFR 801.109)

OR

Over-The-Counter Use ☐
(Optional Format 1-2-96)