(439 days)
Human Albumin CSF Kit for use on SPAPLUS is intended for the in-vitro quantification of human albumin in serum and cerebrospinal fluid (CSF) samples on the SPAPLUS analyser. Measurement of albumin aids in the diagnosis of kidney and intestinal diseases in conjunction with other laboratory and clinical findings.
Not Found
This document is a 510(k) clearance letter from the FDA for "The Binding Site Human Albumin CSF kit for use on SPAplus". It confirms that the device is substantially equivalent to legally marketed predicate devices.
The document does not contain a detailed study report with acceptance criteria and device performance as described in your request. It's a regulatory approval, not a scientific publication presenting study data.
Therefore, I cannot provide the specific information requested about acceptance criteria, sample sizes, ground truth establishment, or expert qualifications based on this document. These details would typically be found in the 510(k) submission itself or in a separate study report, not in the clearance letter.
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Image /page/0/Picture/0 description: The image shows the text "DEPARTMENT OF HEALTH & HUMAN SERVICES". The text is in all caps and is in a bold, sans-serif font. The text is centered in the image and is the only element present. The image is simple and straightforward.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 19, 2013
THE BINDING SITE GROUP LTD. C/O MS. SUZANNE HORNE REGULATORY AFFAIRS MANAGER 8 CALTHORPE ROAD EDGBASTON, BIRMINGHAM, B15 IQT UNITED KINGDOM
Re: K121045
Trade/Device Name: The Binding Site Human Albumin CSF kit for use on SPAplus Regulation Number: 21 CFR 866.5040 Regulation Name: Albumin immunological test system Regulatory Class: II Product Code: DCF Dated: May 13, 2013 Received: May 15, 2013
Dear Ms. Horne:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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 Parts 801 and 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the
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Page 2-Ms. Suzanne Horne
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 regulations (21 CFR Parts 801 and 809), please contact 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. 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/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Maria M. Chan -S
Maria M. Chan, pH. D. Director Division of Immunology and Hematology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known):_k121045
Device Name: Human Albumin CSF Kit for use on SPAPLUS
Indications For Use:
Human Albumin CSF Kit for use on SPAPLUS is intended for the in-vitro quantification of human albumin in serum and cerebrospinal fluid (CSF) samples on the SPAPLUS analyser. Measurement of albumin aids in the diagnosis of kidney and intestinal diseases in conjunction with other laboratory and clinical findings.
Prescription Use X
AND/OR
Over-The-Counter Use
(Part 21 CFR 801 Subpart D)
(21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH; Office of In Vitro Diagnostics and Radiological Health (OIR)
Maria M. Chan -S
Division Sign-Off Office of In Vitro Diagnostics and Radiological Health
510(k): K121045
§ 866.5040 Albumin immunological test system.
(a)
Identification. An albumin immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the albumin (a plasma protein) in serum and other body fluids. Measurement of albumin aids in the diagnosis of kidney and intestinal diseases.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 866.9.