ACL/APS FACS KIT by LOUISVILLE APL DIAGNOSTICS, INC.

The aCL/aPS®FACS Kit is and assay for the semi-quantitative determination of antiphospholipid (anticardiolipin-aCL and antiphosphatidy/serine-aPS) antibodies to be used in the aid of the diagnosis of the Antiphospholipid Syndrome (APS). APS is defined as a disorder of recurrent thrombosis, pregnancy loss and/or thrombocytopenia with persistent positive antiphospholipid tests.

Device Description

ACL/aPS FACS Kit

AI/ML Overview

This document is a marketing clearance letter from the FDA for the ACL/APS FACS Kit. It does not contain any information about acceptance criteria or a study proving the device meets those criteria.

The letter confirms that the device is substantially equivalent to legally marketed predicate devices and can therefore be marketed. It outlines regulatory requirements and provides contact information for various FDA offices.

To provide the requested information, I would need to analyze a different document, such as a summary of safety and effectiveness, a clinical study report, or a 510(k) submission itself, if available.

Summary

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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

MAR 1 8 1999

Silvia S. Pierangeli, Ph.D. Technical Director Louisville APL Diagnostics, Inc. 455 South Fourth Avenue, Suite 1528 Louisville, Kentucky 40202-2510

Re: K984102 Trade Name: ACL/APS FACS Kit Regulatory Class: II Product Code: MID Dated: March 5, 1999 Received: March 8, 1999

Dear Dr. Pierangeli:

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

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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 (770) 488-7655.

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"(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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团 002

510(k) Number (if known):	K 984102
Device Name:	ACL/aPS R FACS kit

Indications For Use:

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number	K984102

Prescription Use	✓
(Per 21 CFR 801.109)

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

Regulation Number and Section

§ 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).