(53 days)
For measuring human haemolytic complement activity by the Classical pathway in human serum, as an aid in the diagnosis of disease associated with complement activation, and with complement component deficiencies.
Total Haemolytic Complement RID Kit
This FDA document, K992488, is a 510(k) clearance letter for a device called "Total Haemolytic Complement RID Kit." It states that the device is substantially equivalent to a legally marketed predicate device.
Crucially, this type of document is a clearance, not a study report or a detailed performance evaluation. Therefore, it does not contain the information requested about acceptance criteria, specific study designs, sample sizes, expert qualifications, or ground truth establishment.
Here's why the requested information cannot be extracted from the provided text:
- 510(k) clearances focus on substantial equivalence. They confirm that a new device is as safe and effective as a legally marketed predicate device, often by demonstrating similar technological characteristics and indications for use. They do not typically provide the detailed clinical study data or performance metrics that would be found in a full study report or premarket approval (PMA) application.
- The document is a letter, not a scientific paper. It's a regulatory communication from the FDA to the manufacturer, not a publication describing a study's methodology and results.
Therefore, I cannot populate the table or answer the specific questions about acceptance criteria, study design, sample size, or ground truth based solely on the provided text.
To obtain the requested information, one would need to access the original 510(k) submission document (if publicly available) or any associated clinical study reports that the manufacturer submitted to the FDA to support their claim of substantial equivalence. These documents would contain the detailed performance data, acceptance criteria, and study methodologies.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
SEP 1 7 1999
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
The Binding Site, Limited C/O Mr. Jay H. Geller East Tower, Suite 600 2425 West Olympic Boulevard Santa Monica, California 90404
Re: K992488
Trade Name: Total Haemolytic Complement RID Kit Regulatory Class: II Product Code: DAE Dated: July 21, 1999 Received: July 26, 1999
Dear Mr. Geller:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895, A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at (770) 488-7655.
This letter will allow you to begin marketing your device as described in your 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 Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers 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 Autman
Steven I. Gutman, M.D, M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Total Haemolytic Complement Kit Device Name:
For measuring human haemolytic complement Indications for Use: Indications for ose. Tor meabway in human serum, as an aid in activity by the Crassical pachar in Maxical Bank, and and with complement component deficiencies.
Peter E. Maksimi
Division Sign-Off
Prescription -
1999 1995 - 1
§ 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).