(187 days)
An enzyme linked immunoassay (ELISA) for the detection and semi-quantitation of IgG antibodies to ß2-GP1, as an aid in assessing the risk of thrombosis in patients with Systemic Lupus Erythematosus (SLE) or lupus like disorders
An enzyme linked immunoassay (ELISA) for the detection and semi-quantitation of IgG antibodies to ß2-GP1
The provided text is an FDA 510(k) clearance letter for the "ImmuLisa Anti-Beta2 Glycoprotein I (ß2GP1) IgG ELISA" device. This document primarily focuses on the regulatory clearance and does not contain the detailed study information typically found in a clinical study report or a 510(k) submission summary that would describe acceptance criteria and study results.
Therefore, I cannot provide the requested information. The document does not describe:
- Acceptance criteria or device performance table.
- Sample size for test set or data provenance. This information would be in the validation study data, not the clearance letter.
- Number of experts, qualifications, or ground truth establishment for the test set. This is not within the scope of this FDA letter.
- Adjudication method.
- MRMC comparative effectiveness study. This device is an ELISA kit, not an AI-assisted diagnostic tool, so this question is not applicable.
- Standalone performance. While the device performs in a standalone manner, the specific performance metrics (sensitivity, specificity, etc.) and the study details proving them are not in this letter.
- Type of ground truth used. This would be in the study design document.
- Sample size for the training set. This device is an ELISA kit, which typically does not involve a "training set" in the machine learning sense. Its development involves standardization and validation with known positive and negative samples.
- How ground truth for the training set was established. (See point 8).
The document is a regulatory approval letter based on a submission that would contain such data, but the letter itself does not detail it.
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Image /page/0/Picture/1 description: The image shows a circular logo with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" written around the perimeter. Inside the circle is a stylized image of an eagle. The eagle is facing left and has three stripes on its wing.
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
Re: K030701
Trade/Device Name: ImmuLisa Anti-Beta, Glycoprotein I (ß,GP1) IgG 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
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INDICATIONS FOR USE STATEMENT
510(k) Number (if known): K_ KO30201_
ImmuLisa Anti-Beta2 Glycoprotein I (ß2GP1) IgG ELISA Device Name:
Indications For Use:
An enzyme linked immunoassay (ELISA) for the detection and semi-quantitation of IgG antibodies to ß2-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)
OR
Prescription Use
(Per 21 CFR 801.109)
Over-The-Counter Use (Optional Format 1-2-96)
un Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number.
Isl
17
§ 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).