APL IGA ELISA KIT

K021398 · Louisville Apl Diagnostics, Inc. · MID · Aug 27, 2002 · Immunology

Device Facts

• Record ID: K021398
• Device Name: APL IGA ELISA KIT
• Applicant: Louisville Apl Diagnostics, Inc.
• Product Code: MID · Immunology
• Decision Date: Aug 27, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.5660
• Device Class: Class 2

Intended Use

The APL® IgA ELISA Kit is a semiquantitative enzyme linked immunosorben assay (ELISA) for use as an aid in diagnosing the Antiphospholipid Syndrome (APS) in patients presenting with thrombosis, pregnancy losses and/or thrombocytopenia. It enables measurement of IgA anticardiolpin antibody levels in human serum.

Device Story

APL® IgA ELISA Kit is an in vitro diagnostic test for human serum; measures IgA anticardiolipin antibody levels. Principle of operation: enzyme-linked immunosorbent assay (ELISA). Used in clinical laboratories by trained personnel. Output: semiquantitative measurement of IgA antibodies. Results assist clinicians in diagnosing Antiphospholipid Syndrome (APS) in patients with clinical symptoms like thrombosis, pregnancy loss, or thrombocytopenia. Supports clinical decision-making by confirming presence of autoantibodies associated with APS.

Clinical Evidence

No clinical data provided in the document; substantial equivalence is based on bench testing and performance characteristics typical of ELISA-based immunological test systems.

Technological Characteristics

Semiquantitative enzyme-linked immunosorbent assay (ELISA) for IgA anticardiolipin antibodies. Analyte: human serum. Class II device (21 CFR 866.5660).

Indications for Use

Indicated for patients with suspected Antiphospholipid Syndrome (APS) presenting with unexplained venous thrombosis (recurrent or unusual sites), arterial occlusion (stroke, myocardial infarction, peripheral gangrene), unexplained pregnancy losses (one or more 2nd/3rd trimester or two or more 1st trimester), or unexplained thrombocytopenia.

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

Image /page/0/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services (USA). The logo features the department's name in a circular arrangement around a stylized symbol. The symbol consists of three curved lines that resemble a person embracing another person.

Public Health Service

AUG 2 7 2002

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Silvia S. Pierangeli, Ph.D. Technical Director Louisville APL Diagnostics, Inc. 3988 Flowers Road - Suite 620 Doraville, GA 30360

Re: k021398 Trade/Device Name: APL® IgA ELISA Kit Regulation Number: 21 CFR 866.5660 Regulation Name: Multiple autoantibodies immunological test system Regulatory Class: Class II Product Code: MID Dated: July 25, 2002 Received: July 29, 2002

Dear Dr. Pierangeli:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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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 1 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" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers International and Consumer Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrb/dsmaldsmamain.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: | K021398 |
|-------------------------|--------------------|
| Device Name: | APL® IgA ELISA Kit |

## Indications for Use:

The Antiphospholipid Syndrome is a clinical diagnosis supported by finding a positive antiphospholipid ELISA and/or lupus anticoagulant test. Indications for the test include: patients with unexplained venous thrombosis, particularly if recurrent or at unusual sites as the inferior vena cava or renal veins; unexplained venous thrombosis, particularly if recurrent or at unusual sites as the inferior vena cava or renal veins; unexplained occlusion of the arterial circulation resulting in stroke, myocardial infarction, or peripheral gangrene. In patients with unexplained venous thrombosis, other disorder should be excluded, such as protein C, S, or antithrombin III deficiency, as well as malignancy or the nephrotic syndrome. The test is also indicated in women with one or more unexplained second or third trimester pregnancy losses or two or more first trimester losses. Finally, patients with unexplained thrombocytopenia as well as other abnormalities said to be associated with the Antiphospholipid Syndrome should be tested.

## Intended Use

The APL® IgA ELISA Kit is a semiquantitative enzyme linked immunosorben assay (ELISA) for use as an aid in diagnosing the Antiphospholipid Syndrome (APS) in patients presenting with thrombosis, pregnancy losses and/or thrombocytopenia. It enables measurement of IgA anticardiolpin antibody levels in human serum.

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**510(k) Number** K021398

Prescription Use (Per 21 CFR 801.109)

OR

Over the counter USE (Optional Format 1-2-96)