(62 days)
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.
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)
This document is a 510(k) premarket notification approval letter for the Immuno Concepts Incorporated's Auto I.D.® Jo-1, Scl-70, and PCNA Positive Controls. It indicates the products are substantially equivalent to legally marketed predicate devices. This type of document does not contain details about specific acceptance criteria or an in-depth study proving device performance against those criteria.
The purpose of a 510(k) submission is to demonstrate substantial equivalence, not necessarily to provide detailed performance studies in the way you might find for a novel, high-risk device. The approval letter confirms the device can be legally marketed, but it doesn't typically elaborate on the specific performance study results that were part of the submission package.
Therefore, I cannot provide the requested information because the provided text does not contain it. The text focuses on the regulatory approval, indicating the device is a "qualitative calibrator/control to confirm the presence of antibodies to autoantigens." This implies performance validation related to its role as a control, likely confirming the presence of the respective antibodies, but the details of such validation are not in this approval letter.
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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 (301) 594-3084. 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 (800) 638-2041 or (301) 443-6597 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
§ 866.5100 Antinuclear antibody immunological test system.
(a)
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).(b)
Classification. Class II (performance standards).