AUTO I.D. JO-1, SCL-70 & PCNA POSITIVE CONTROL SERUM

K030775 · Immuno Concepts, N.A. , Ltd. · LKJ · May 12, 2003 · Immunology

Device Facts

• Record ID: K030775
• Device Name: AUTO I.D. JO-1, SCL-70 & PCNA POSITIVE CONTROL SERUM
• Applicant: Immuno Concepts, N.A. , Ltd.
• Product Code: LKJ · Immunology
• Decision Date: May 12, 2003
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 866.5100
• Device Class: Class 2

Indications for Use

These are qualitative calibrators/controls to confirm the presence of antibodies to autoantigens (Jo-1, Scl-70, or PCNA) in human serum. Antibodies to Jo-1 are found in patients with polymyositis and dermatomyositis, antibodies to Scl-70 are found in patients with scleroderma, and antibodies to PCNA are found in patients with systemic lupus erythematosus. These optional controls are intended for use with the Immuno Concepts AUTO-ID® Autoantibody Test System.

Device Story

AUTO I.D.® Positive Control Serums (Jo-1, Scl-70, PCNA) serve as qualitative laboratory controls for the Immuno Concepts AUTO-ID® Autoantibody Test System. These controls are used by laboratory professionals to verify the presence of specific autoantibodies in human serum samples. By providing a known positive result, they ensure the performance and validity of the test system during clinical diagnostic procedures for autoimmune conditions including polymyositis, dermatomyositis, scleroderma, and systemic lupus erythematosus. The controls assist clinicians in confirming patient antibody status, thereby supporting accurate diagnosis and management of these autoimmune diseases.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Qualitative human serum-based controls. Designed for use with the Immuno Concepts AUTO-ID® Autoantibody Test System. Product code: LKJ. Regulation: 21 CFR 866.5100 (ANA Immunological Test System).

Indications for Use

Indicated for use as qualitative calibrators/controls to confirm presence of autoantibodies (Jo-1, Scl-70, or PCNA) in human serum. Jo-1 antibodies associated with polymyositis/dermatomyositis; Scl-70 with scleroderma; PCNA with systemic lupus erythematosus. Intended for use with Immuno Concepts AUTO-ID® Autoantibody Test System.

Regulatory Classification

Identification

An antinuclear antibody immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the autoimmune antibodies in serum, other body fluids, and tissues that react with cellular nuclear constituents (molecules present in the nucleus of a cell, such as ribonucleic acid, deoxyribonucleic acid, or nuclear proteins). The measurements aid in the diagnosis of systemic lupus erythematosus (a multisystem autoimmune disease in which antibodies attack the victim's own tissues), hepatitis (a liver disease), rheumatoid arthritis, Sjögren's syndrome (arthritis with inflammation of the eye, eyelid, and salivary glands), and systemic sclerosis (chronic hardening and shrinking of many body tissues).

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol consisting of three stylized human profiles facing to the right, with flowing lines suggesting movement or connection.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Eric S. Hoy, Ph.D., AI(ASCP) Chief Scientific Officer Immuno Concepts Incorporated 9779 "D" Business Park Drive Sacramento, California 95827

> k030775 Trade/Device Name: Auto I.D.® Jo-1 Positive Control Auto I.D.® Scl-70 Positive Control Auto I.D.® PCNA Positive Control Regulation Number: 21 CFR & 866.5100 Regulation Name: ANA Immunological Test System Regulatory Class: II Product Code: LKJ Dated: March 10, 2003 Received: March 11, 2003

Dear Dr. Hoy :

Re:

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.

MAY 1 2 2003

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 Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed

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If you desire specific information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act 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/cdrh/dsma/dsmamain.html.

Sincerely yours,

Steven Sutman

Steven I. Gutman, M.D., M.B.A. Director Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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510(k) number (if known):

Device Name: AUTO I.D.® Positive Control Serum

HD30 175

Trade or Proprietary Name:

AUTO-I.D.® Jo-1 Positive Control Serum (Catalog number 6004) AUTO-I.D.® Sc1-70 Positive Control Serum (Catalog number 6005) AUTO-I.D.® PCNA Positive Control Serum (Catalog number 6006)

## Indications for use:

These are qualitative calibrators/controls to confirm the presence of antibodies to autoantigens (Jo-1, Scl-70, or PCNA) in human serum. Antibodies to Jo-1 are found in patients with polymyositis and dermatomyositis, antibodies to Scl-70 are found in patients with scleroderma, and antibodies to PCNA are found in patients with systemic lupus erythematosus. These optional controls are intended for use with the Immuno Concepts AUTO-ID® Autoantibody Test System.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

H. Reeves for J. Bautista

(Division Sign-Off)
Division of Clinical Laboratory Devices,
510(k) Number (20307, 5

Prescription Use
(Per 21 CFR 801.109) √

OR Over-The-Counter Use