(18 days)
The Zeus Scientific, Inc. ANCA Screen ELISA test system is intended for the qualitative detection of IgGclass antibody to myeloperoxidase and/or proteinase-3 in human serum. The test system is intended to be used as an automated or manual aid in the diagnosis of various autoimmune vasculitic disorders characterized by elevated levels of anti-neutrophil cytoplasmic antibodies (ANCA) to MPO and/or PR-3 ANCA may be associated with autoimmune disorders such as Wegener's Granulamotosis, Idiopathic Crescentic Glomerulonephritis, Microscopic Polyarteritis, and Pulmonary Renal Syndrome. This test is for in vitro diagnostic use.
Not Found
This document is a 510(k) clearance letter from the FDA for a medical device called "The Aptus (automated) Application of the ANCA Screen ELISA test system." It does not contain any information about acceptance criteria or a study that proves the device meets acceptance criteria.
The letter is a regulatory document confirming that the device is substantially equivalent to legally marketed predicate devices and can therefore be marketed. It discusses the regulatory class, product code, and general controls provisions of the Federal Food, Drug, and Cosmetic Act.
To answer your request, I would need a document that describes the actual performance study and its results, along with the predetermined acceptance criteria.
{0}------------------------------------------------
Image /page/0/Picture/2 description: The image shows the seal of the Department of Health & Human Services USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. In the center of the seal is a stylized image of a caduceus, a symbol of medicine and healing. The caduceus consists of a staff with two snakes coiled around it and wings at the top.
NOV 3 0 1998
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Mark J. Kopnitsky V.P., Research and Development ZEUS SCIENTIFIC, INC. 200 Evans Way Branchburg, NJ 08876
Re: K984034 Trade Name: The Aptus (automated) Application of the ANCA Screen ELISA test system Requlatory Class: II Product Code: MOB November 09, 1998 Dated: Received: November 12, 1998
Dear Mr. Kopnitsky:
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 aqainst 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 requlation 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 requlations.
{1}------------------------------------------------
Page 2
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
{2}------------------------------------------------
Page 1 of 1
510(k) Number (if known): 齐日4
Device Name: Aptus (automated) Application for the ANCA Screen ELISA Test System
Indications for Use:
The Zeus Scientific, Inc. ANCA Screen ELISA test system is intended for the qualitative detection of IgGclass antibody to myeloperoxidase and/or proteinase-3 in human serum. The test system is intended to be used as an automated or manual aid in the diagnosis of various autoimmune vasculitic disorders characterized by elevated levels of anti-neutrophil cytoplasmic antibodies (ANCA) to MPO and/or PR-3 ANCA may be associated with autoimmune disorders such as Wegener's Granulamotosis, Idiopathic Crescentic Glomerulonephritis, Microscopic Polyarteritis, and Pulmonary Renal Syndrome. This test is for in vitro diagnostic use.
Cutter E. Mackin
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use _ V
OR
Over-The-Counter Use
(Per 21 CFR 801,109)
(Optional Format 1-
2-96)
§ 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).