(127 days)
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Not Found
No
The description details a standard enzyme immunoassay and does not mention any AI or ML components.
No
The device is an in vitro diagnostic test used to detect circulating immune complexes in human serum as an aid in diagnosis, not to directly treat or alleviate a disease.
Yes
The device is described as an "in vitro diagnostic detection" tool used "as an aid in the diagnosis of various autoimmune and other CIC related diseases."
No
The device is described as a "semi-quantitative enzyme immunoassay," which is a laboratory test method involving chemical reactions and physical components, not solely software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The description explicitly states "for the in vitro diagnostic detection of circulating immune complex that bind C3d in human serum." It also mentions its use as an "aid in the diagnosis of various autoimmune and other CIC related diseases."
- Device Description: The description reiterates "semi-quantitative enzyme immunoassay for the in vitro diagnostic detection of circulating immune complex that bind C3d in human serum."
- Anatomical Site: It specifies "human serum," which is a biological sample taken from the human body for in vitro testing.
All of these points align with the definition of an In Vitro Diagnostic device, which is used to examine specimens derived from the human body to provide information for the diagnosis, prevention, or treatment of a disease or condition.
N/A
Intended Use / Indications for Use
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.
Product codes
CZW
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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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)
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc)
Not Found
§ 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).
0
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
2
Page _1 of _1
510(k) Number (if known): __ K032796
Device Name: ______IBL_C3d-CIC EIA Test
Indications For Use:
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.
(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)
OR
Over-The-Counter Use (Optional Format 1-2-96)