(187 days)
None
Not Found
No
The summary describes an immunoassay (ELISA), which is a laboratory test, and there is no mention of AI, ML, image processing, or any computational analysis beyond standard assay interpretation.
No
The device is an in vitro diagnostic (IVD) immunoassay designed for detection and semi-quantitation of antibodies as an aid in risk assessment. It does not provide treatment or therapy.
Yes
The device is described as an aid in assessing the risk of thrombosis in patients with SLE, which indicates it provides information for diagnosis or assessment of a medical condition.
No
The 510(k) summary describes an enzyme linked immunoassay (ELISA), which is a laboratory test involving physical reagents and equipment, not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that it is an "enzyme linked immunoassay (ELISA) for the detection and semi-quantitation of IgM antibodies to B2-GP1". This describes a test performed in vitro (outside the body) on a biological sample (presumably blood or serum, as antibodies are being detected).
- Purpose: The purpose is to aid in assessing the risk of thrombosis in patients with SLE or lupus-like disorders. This is a diagnostic purpose, providing information about a patient's health status.
IVDs are defined as reagents, instruments, and systems intended for use in the diagnosis of disease or other conditions, including a determination of the state of health, in order to cure, mitigate, treat, or prevent disease or its sequelae. This device fits that definition.
N/A
Intended Use / Indications for Use
An enzyme linked immunoassay (ELISA) for the detection and semi-quantitation of IgM antibodies to B2-GP1, as an aid in assessing the risk of thrombosis in patients with Systemic Lupus Erythematosus (SLE) or lupus like disorders
Product codes
MSV
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/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle.
Mr. Kevin J. Lawson Director, Regulatory Affairs IMMCO Diagnostics, Inc. 60 Pineview Drive Buffalo, New York 14228
SEP - 9 2003
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
K030702 Re: Trade/Device Name: ImmuLisa Anti-Beta2 Glycoprotein I (ß,GP1) IgM ELISA Regulation Number: 21 CFR § 866.5660 Regulation Name: Multiple Autoantibodies, Immunological Test Regulatory Class: II Product Code: MSV Dated: June 16, 2003 Received: August 28, 2003
Dear Mr. Lawson:
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.
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 predicate device results in a classification for your device and thus, permits your device to proceed to the market.
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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
2
INDICATIONS FOR USE STATEMENT
510(k) Number (if known): K Q30 I O Z __
Device Name: ImmuLisa Anti-Beta2 Glycoprotein I (B2GP1) IgM ELISA
- Indications For Use: An enzyme linked immunoassay (ELISA) for the detection and semi-quantitation of IgM antibodies to B2-GP1, as an aid in assessing the risk of thrombosis in patients with Systemic Lupus Erythematosus (SLE) or lupus like disorders
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use (Optional Format 1-2-96)
/1/07(Division Sign-Off) Division of Clinical Laboratory Devices 510(k) NumberK030702