(38 days)
Not Found
Not Found
No
The summary describes a standard enzyme immunoassay for detecting immune complexes in serum and contains no mention of AI or ML.
No
The device is an in vitro diagnostic test used to detect circulating immune complexes as an aid in diagnosis, not to treat or therapeutically intervene.
Yes
The "Intended Use / Indications for Use" section explicitly states "in vitro diagnostic detection" and "as an aid in the diagnosis of various autoimmune and other CIC related diseases."
No
The device is an in vitro diagnostic test that measures a substance in human serum using an enzyme immunoassay. This process inherently involves physical reagents and laboratory equipment, not just software.
Based on the provided information, yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use / Indications for Use: The statement explicitly says "for the in vitro diagnostic detection of circulating immune complex that bind C1q in human serum." The phrase "in vitro diagnostic" is a direct indicator.
- Purpose: The test is intended to "aid in the diagnosis of various autoimmune and other CIC related diseases." This aligns with the purpose of IVD devices, which are used to provide information for diagnosis.
- Sample Type: The test is performed on "human serum," which is a biological sample commonly used in IVD testing.
The other sections being "Not Found" or "Not Applicable" do not negate the clear statement of "in vitro diagnostic" in the intended use.
N/A
Intended Use / Indications for Use
The IBL C1q-CIC test is a quantitative enzyme immunoassay for the in vitro diagnostic detection of circulating immune complex that bind C1q 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
DAK
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
§ 866.5240 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
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services (HHS). The logo consists of a stylized caduceus, which is a symbol often associated with medicine and healthcare. The caduceus is surrounded by the words "U.S. Department of Health & Human Services" in a circular arrangement.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Immuno-Biological Laboratories, Hamburg c/o Mr. Gary Lehnus Lehnus & Associates Consulting 150 Cherry Lane Road East Stroudsburg, PA 18301
AUG 2 9 2003
Re: K032254
Trade/Device Name: IBL C1q-CIC EIA Test Regulation Number: 21 CFR § 866.5240 Regulation Name: Complement C1q, Antigen, Antiserum, Control Regulatory Class: II Product Code: DAK Dated: July 15, 2003 Received: July 22, 2003
Dear Mr. Lehnus:
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 vour 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.
1
Page 2 -
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
Page 1 of 1
510(k) Number (if known): K032254
Device Name:
Indications For Use:
The IBL C1q-CIC test is a quantitative enzyme immunoassay for the in vitro diagnostic detection of circulating immune complex that bind C1q 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)
A.L. Reeves for T. O'leary
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) 15032254
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use (Optional Format 1-2-96)