(198 days)
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No
The summary describes a turbidimetric assay for quantitative determination of a substance in serum, which is a standard laboratory technique and does not mention any AI or ML components.
No
The device is described as a kit for "quantitative in vitro determination of human C4 in serum," which is a diagnostic function, not a therapeutic one.
Yes
The device is intended for the quantitative in vitro determination of human C4 in serum, which is a diagnostic measurement used in conjunction with other laboratory and clinical findings to assess a patient's health status.
No
The intended use describes a "kit" for in vitro determination using a "turbidimetric analyser," which are hardware components, not software-only.
Yes, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states:
"This kit is intended for the quantitative in vitro determination of human C4 in serum using the Binding Site SPAPLUS™ turbidimetric analyser."
The phrase "in vitro determination" is the key indicator that this device is an IVD. IVD devices are used to examine specimens taken from the human body (like serum in this case) outside of the body to provide information for diagnosis, monitoring, or screening.
N/A
Intended Use / Indications for Use
This kit is intended for the quantitative in vitro determination of human C4 in serum using the Binding Site SPAPLUS™ turbidimetric analyser. This test should be used in conjunction with other laboratory and clinical findings
Product codes
DBI
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)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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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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. The logo consists of a stylized eagle with its wings spread, surrounded by a circle of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". The eagle is black, and the text is also black.
Public Health Service
Food & Drug Administration 10903 New Hampshire Avenue Building 66 Silver Spring, MD 20993
SEP 0 3 2010
The Binding Site Group, Ltd. c/o Mr. Jay H. Geller Authorized U.S. Representative 12100 Wilshire Boulevard. Suite 500 Los Angeles, CA 90025-7121
Re: K100455
Trade/Device Name: Human C4 Kit for use on SPAPLUSTM Regulation Number: 21 CFR § 866.5240 Regulation Name: Complement components immunological test system Regulatory Class: II Product Code: DBI Dated: August 25, 2010 Received: August 26, 2010
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 class II (Special Controls), 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); medical device reporting (reporting of
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Page 2 - Mr. Jay H. Geller
medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (OS) 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
m chan
Maria M. Chan, Ph.D. Director Division of Immunology and Hematology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known): K100455
SEP 0 3 2010
Device Name: Human C4 Kit for use on SPAPLUS™
Indications For Use:
0
This kit is intended for the quantitative in vitro determination of human C4 in serum using the Binding Site SPAPLUS™ turbidimetric analyser. This test should be used in conjunction with other laboratory and clinical findings
Prescription Use X (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
AND/OR
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Reena Philip
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
510K K100455