(114 days)
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Not Found
No
The summary describes an in-vitro diagnostic assay for measuring immune complexes and contains no mention of AI or ML technologies.
No
The device is described as an "in-vitro measurement of circulating immune complexes," which is a diagnostic tool used to identify the presence of certain indicators in a patient's body. It is not depicted as delivering any form of treatment or therapy.
Yes
The assay is intended for the in-vitro measurement of circulating immune complexes to determine their presence in patients with various autoimmune and other CIC-related diseases, and is used in conjunction with other clinical findings. This clearly indicates its use in aiding diagnosis.
No
The intended use describes an "in-vitro measurement of circulating immune complexes (CIC) that bind Clq, measurement on on serum." This strongly suggests a laboratory assay, which typically involves physical reagents and equipment, not just software. The lack of a device description further supports this interpretation as it doesn't provide any information to contradict the implication of a hardware-based assay.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states that the assay is designed for the in-vitro measurement of circulating immune complexes (CIC) in serum. This directly aligns with the definition of an in vitro diagnostic device, which is used to examine specimens derived from the human body to provide information for diagnostic purposes.
- Specimen Type: The assay uses serum, which is a biological specimen derived from the human body.
- Purpose: The assay is intended for the "determination of presence in names patients with various autoimmune and other CICrelated disease, and is used in conjunction with other clinical findings." This indicates a diagnostic purpose, providing information to aid in the diagnosis or management of diseases.
The other sections being "Not Found" or "Not Applicable" do not negate the clear indication in the "Intended Use" section that this is an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
"This assay is designed for the in-vitro measurement of circulating immune complexes (CIC) that bind Clq, measurement on on serum. It is intended for the determination of presence in names patients with various autoimmune and other CICrelated disease, and is used in conjunction with other clinical findings."
Product codes
DAK
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)
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).
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Image /page/0/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized image of an eagle or bird-like figure with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" is arranged in a circular pattern around the bird symbol. The text is in all capital letters and is evenly spaced around the circle.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
SEP 1 0 2003
The Binding Site, Limited c/o Mr. Jay H. Geller 2425 West Olympic Boulevard West Tower, Suite 4000 Santa Monica, California 90404
Re: K031563
Trade/Device Name: BINDAZYME C1q Binding Circulating Immune Complex Enzyme Immunoassay Kit Regulation Number: 21 CFR § 866.5240 Regulation Name: Complement Components Immunological Test System Regulatory Class: II Product Code: DAK Dated: July 28, 2003 Received: July 31, 2003
Dear Mr. Geller:
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,
ﺮ ﺍﻟﻤﺮﺍﺟﻊ
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
BINDAZYME Clq Binding Circulating Immune Complex Device Name: Enzyme Immunoassay Kit
Indications for Use: This assay is designed for the in-vitro measurement of circulating immune complexes (CIC) that bind Clq, measurement on on serum. It is intended for the determination of presence in names patients with various autoimmune and other CICrelated disease, and is used in conjunction with other clinical findings.
Ty/or
Division Sign-Off
g in
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k)