(204 days)
This kit is intended for the quantitative in vitro determination of human C3c in serum using the Binding Site SPAPLUS™ turbidimetric analyser. This test should be used in conjunction with other laboratory and clinical findings.
Not Found
The provided text is related to a 510(k) premarket notification for a medical device called "Human C3c Kit for use on SPAPLUSTM". It grants substantial equivalence to legally marketed predicate devices, but it does not contain a detailed study report with acceptance criteria, performance data, or information about sample sizes, ground truth establishment, or expert involvement as requested.
The document is an FDA clearance letter and an "Indications for Use" statement. It does not describe a performance study in the way a scientific paper or a detailed clinical trial report would.
Therefore, I cannot fulfill your request for detailed information regarding acceptance criteria and a study proving the device meets those criteria based only on the provided text. The text confirms the device's intended use and regulatory status but does not describe the specific performance study that led to its clearance.
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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 stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES (USA)" are arranged in a circle around the eagle. The eagle is black, and the text is also black. The logo is simple and recognizable.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-0609 Silver Spring, MD 20993-0002
SEP 1 4 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: K100179
Trade/Device Name: Human C3c Kit for use on SPAPLUSTM Regulation Number: 21 CFR §866.5240 Regulation Name: Complement components immunological test system Regulatory Class: Class II Product Code: CZW Dated: August 2, 2010 Received: August 9, 2009
Dear Mr. Geller:
This letter corrects our substantially equivalent letter of 8/13/2009.
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 (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 additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. 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 Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
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Page 2 - Mr. Jay H. Geller
forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Maria 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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Indications for Use
.
AUG 1 3 2010
510(k) Number (if known): K100179
Device Name: Human C3c Kit for use on SPAPLUSTM
Indications for Use: This kit is intended for the quantitative in vitro determination of human C3c in serum using the Binding Site SPAPLUS™ turbidimetric analyser. This test should be used in conjunction with other laboratory and clinical findings.
Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Manaí In Chan Attachment D
Division Sign-Off
ﺔ ﻓﻲ
Office of In Vitro Dlagnostic Device Evaluation and Safety
510(k) K100179
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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).