(24 days)
Not Found
Not Found
No
The 510(k) summary describes an ELISA test system for detecting antibodies, which is a standard laboratory technique and does not mention any AI or ML components.
No
This device is an in vitro diagnostic test system that aids in the diagnosis of autoimmune disorders by detecting antibodies, not a therapeutic device.
Yes.
The "Intended Use / Indications for Use" states that the test system is "intended to be used as an automated or manual aid in the diagnosis of various autoimmune vasculitic disorders".
No
The device is an ELISA test system, which is an in vitro diagnostic (IVD) test that involves laboratory reagents and procedures, indicating it is a hardware-based device, not software-only.
Yes, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states:
"This test is for in vitro diagnostic use."
This statement, along with the description of the test system's purpose (detecting antibodies in human serum to aid in the diagnosis of autoimmune disorders), clearly indicates that it is an IVD device.
N/A
Intended Use / Indications for Use
The Zeus Scientfic, Inc. MPO ELISA test system is intended for the semi-quantitative detection of IgGclass antibody to myeloperoxidase 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 antibodies to MPO. Elevated antibody levels to MPO may be associated with autoimmune disorders such as Wegener's Granulomatosis, Idiopathic Crescentic Glomerulonephritis, Microscopic Polyarteritis, and Pulmonary Renal Syndrome. This test is for in vitro diagnostic use.
Product codes
MOB
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, surrounded by a circular border. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged around the top of the circle.
JAN 1 1 1999
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Mr. Mark J. Kopnitsky Vice President, Research and Development Zeus Scientific. Inc. 200 Evans Way Branchburg, New Jersey 08876
Re: K984516
Trade Name: The Aptus (Automated) Application of the MPO ELISA Test System Regulatory Class: II Product Code: MOB Dated: December 17, 1998 Received: December 18, 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 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 (OS) 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 Radiation Control provisions, or other Federal laws or regulations.
1
Page 2
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
2
Page 1
510(k) Number (if known): ¸K984516
Device Name: Aptus (automated) Application for the MPO ELISA Test System
Indications for Use:
The Zeus Scientfic, Inc. MPO ELISA test system is intended for the semi-quantitative detection of IgGclass antibody to myeloperoxidase 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 antibodies to MPO. Elevated antibody levels to MPO may be associated with autoimmune disorders such as Wegener's Granulomatosis, Idiopathic Crescentic Glomerulonephritis, Microscopic Polyarteritis, and Pulmonary Renal Syndrome. This test is for in vitro diagnostic use.
Peter E. Mason
(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)