IBL C3D-CIC EIA TEST by IBL GMBH

The IBL C3d-CIC test is a semi-quantitative enzyme immunoassay for the in vitro diagnostic detection of circulating immune complex that bind C3d in human serum. The measurement is performed as an aid in the diagnosis of various autoimmune and other CIC related diseases. Levels of these complexes are one indicator in a multi-factorial diagnostic regime.

Device Description

semi-quantitative enzyme immunoassay for the in vitro diagnostic detection of circulating immune complex that bind C3d in human serum.

AI/ML Overview

I apologize, but the provided text from the FDA 510(k) clearance letter for the "IBL C3d-CIC EIA Test" does not contain the detailed information required to describe the acceptance criteria and the study that proves the device meets them.

The letter primarily covers:

The FDA's determination of substantial equivalence to a predicate device.
Regulatory classifications and requirements.
Contact information for various FDA offices.
The "Indications For Use" statement for the device.

It explicitly states that the device is "substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices." This means the FDA's decision is based on a comparison to an existing device, rather than a detailed presentation of a new study demonstrating performance against specific acceptance criteria within this document. Such study details are typically found in the full 510(k) submission, which is not provided here.

Therefore, I cannot extract the following information from the given text:

A table of acceptance criteria and the reported device performance: This document does not specify any quantitative acceptance criteria or performance metrics for the IBL C3d-CIC EIA Test itself.
Sample size used for the test set and the data provenance: Not mentioned.
Number of experts used to establish the ground truth for the test set and their qualifications: Not mentioned.
Adjudication method for the test set: Not mentioned.
If a multi reader multi case (MRMC) comparative effectiveness study was done, if so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable, as this is an in-vitro diagnostic (IVD) test, not an AI-assisted diagnostic imaging device for human readers.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, this is an IVD kit, not an algorithm. Its performance is its standalone performance.
The type of ground truth used: Not mentioned.
The sample size for the training set: Not mentioned.
How the ground truth for the training set was established: Not mentioned.

The "Indications For Use" section provides context for the device's purpose:

Device Name: IBL C3d-CIC EIA Test
Indications For Use: A semi-quantitative enzyme immunoassay for the in vitro diagnostic detection of circulating immune complex that bind C3d in human serum. The measurement is performed as an aid in the diagnosis of various autoimmune and other CIC related diseases. Levels of these complexes are one indicator in a multi-factorial diagnostic regime.

To get the information you're looking for, one would need access to the full 510(k) submission document (Premarket Notification) itself, which contains the detailed scientific and clinical data submitted to the FDA.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or a stylized human figure with outstretched arms, composed of three curved lines.

JAN 1 3 2004

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Immuno-Biological Laboratories (IBL)-Hamburg C/O Lehnus and Associates Consulting 150 Cherry Lanc Rd. East Stroudsburg, PA 18301

Re: K032796

Trade/Device Name: IBL C3d-CIC EIA test Regulation Number: 21 CFR 866.5240 Regulation Name: Complement Components Immunological Test System Regulatory Class: Class II Product Code: CZW Dated: September 5, 2003 Received: September 9, 2003

Dear Mr. Lchnus:

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 IDA 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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Page 2 – Mr. G. Lehnus

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,

Pwer Autman, M.D.

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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Page _1 of _1

510(k) Number (if known): __ K032796

Device Name: ______IBL_C3d-CIC EIA Test

Indications For Use:

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

bn chan

(Division Sign-Off) Division of Clinical Laboratory Devices

KO32796 510(k) Number -

Prescription Use
(Per 21 CFR 801.109)

Over-The-Counter Use (Optional Format 1-2-96)

Regulation Number and Section

§ 866.5240 Complement components immunological test system.

(a)
Identification. A complement components immunological test system is a device that consists of the reagents used to measure by immunochemical techniques complement components C1q , C1r , C1s , C2 , C3 , C4 , C5 , C6 , C7 , C8 , and C9 , in serum, other body fluids, and tissues. Complement is a group of serum proteins which destroy infectious agents. Measurements of these proteins aids in the diagnosis of immunologic disorders, especially those associated with deficiencies of complement components.(b)
Classification. Class II (performance standards).